• Bausch + Lomb has received European CE Mark approval for its next-generation SeeLyra femtosecond laser
• The compact platform combines live swept-source OCT with applications for premium cataract, LASIK flap, and corneal therapeutic procedures
• Limited European availability is planned in the coming months, with broader availability expected in 2027 

Bausch + Lomb announced that its next-generation SeeLyra femtosecond laser has received CE Mark approval in Europe, clearing the way for a limited commercial rollout in the region in the coming months.

The platform is designed for laser preparation in premium cataract surgery, LASIK flap creation, and corneal therapeutic procedures. According to the company, SeeLyra combines a compact footprint with features intended to provide surgeons with greater precision and control while accommodating operating room workflow requirements.

“Building on over 15 years of experience in the femtocataract laser market, our goal was to deliver a platform that provides both enhanced functionality and greater flexibility to the OR,” Luc Bonnefoy, president of Surgical at Bausch + Lomb, said in a statement. “SeeLyra delivers, helping surgeons achieve the precise preparation and controlled conditions necessary to unlock the full potential of premium cataract surgery without compromising on space or efficiency.”

SeeLyra incorporates live swept-source optical coherence tomography (OCT), providing real-time depth visualization during procedures. Bausch + Lomb said the technology is intended to help reduce variability during docking, facilitate precise positioning of laser cuts, and provide visualization during laser application.

The system also carries forward features from the company’s previous-generation Victus femtosecond platform, including an interface designed to streamline setup and support multiple surgical applications.

SeeLyra does not use a fixed patient bed and is compatible with existing bed configurations. According to Bausch + Lomb, the design allows the laser to be repositioned and transported within space-constrained operating rooms and eliminates the need for patients to switch beds between procedures. An articulating swing arm also allows the system to accommodate surgeons’ preferred operating orientation.

“Premium surgery success begins with precise surgical preparation of the eye,” José Manuel Larrosa, MD, of the University of Zaragoza in Spain, said in the announcement. “SeeLyra will help me to achieve this consistently on my terms, while fitting seamlessly and efficiently into our OR space and workflow.”

Bausch + Lomb expects SeeLyra to become available on a limited basis in Europe in the coming months, followed by increased availability in 2027.

The company is also pursuing regulatory approvals for the platform in other markets, including the United States. Indications and regulatory approvals will vary by country.

• Ziemer will highlight 4 innovations spanning cataract, refractive, and phakic IOL surgery at ESCRS 2026
• Femto Posterior Capsulotomy expands the Femto Z8 platform with an OCT-guided approach to creating a posterior capsulotomy
• Uniqa and the Epic Phakic Lens App Suite are designed to provide a more integrated workflow for phakic IOL planning and surgery

Ziemer is set to showcase several additions to its cataract, refractive, and therapeutic surgery portfolio at the European Society of Cataract and Refractive Surgeons (ESCRS) 2026 meeting, highlighting expanded applications of its femtosecond laser technology.

The company will feature 4 key innovations at Booth B.340: Femto Posterior Capsulotomy, Soft/Surface Clear, the Uniqa phakic lens, and the Epic Phakic Lens App Suite.

Femto Posterior Capsulotomy represents a new application for Ziemer’s Femto Z8 platform. According to the company, the technology uses intraoperative optical coherence tomography (OCT) to visualize the posterior capsule and guide creation of a circular posterior capsulotomy.

Ziemer will also introduce Soft/Surface Clear, which extends its Clear lenticule-based refractive surgery technology to the corneal surface. The approach is intended to broaden the potential applications of lenticule-based procedures in refractive surgery.

The company is also expanding its refractive portfolio with Uniqa, a phakic IOL manufactured in Switzerland. Ziemer said the system is designed to provide an integrated phakic IOL surgery workflow spanning preoperative planning, surgery, and postoperative assessment, with an emphasis on improving vault predictability and consistency of long-term outcomes.

Complementing the lens is Epic, Ziemer’s Phakic Lens App Suite. The software suite is designed to support precise and reproducible surgical steps using OCT guidance on the Femto Z8 platform.

Together, Uniqa and Epic reflect Ziemer’s effort to integrate phakic IOL planning and implantation more closely with its femtosecond laser ecosystem.

Attendees can view the technologies and meet with Ziemer’s clinical experts at Booth B.340 during ESCRS 2026.

• Hexiris Ophthalmics will present its OBi platform and first-in-human clinical findings at five ophthalmology meetings across Europe and North America this fall
• OBi Core is designed to enable minimally invasive, ab externo filtration surgery at the slit lamp without capital equipment, potentially expanding access beyond the operating room

Hexiris Ophthalmics announced a fall program spanning five major ophthalmology meetings in Europe and North America, where the company will present its OBi platform and first-in-human clinical results. First up: co-founder Dr. Nir Shoham-Hazon will present the company and its clinical experience at the Ophthalmology Futures Forum in London on September 10, during the week of the 44th ESCRS Annual Congress.

Hexiris was founded by surgeons Dr. Houfar Sekhavat and Dr. Nir Shoham-Hazon after humanitarian missions in Gabon, Mozambique and Mexico, where they saw the same reality in every clinic: effective treatments for glaucoma exist, but far too many patients cannot access them. The bottleneck is access to an operating room.

Hexiris' OBi platform is a family of instruments comprising OBi Core, OBi Gon, OBi Shunt and OBi Spacer. Together they span the major aqueous outflow pathways, from angle-based procedures to subconjunctival filtration, and are designed to bring glaucoma surgery out of the operating room and to the slit lamp. The first procedure to market, OBi Core, is a minimally invasive, ab externo, transconjunctival bleb surgery designed to offer a simplified, office-based approach to filtration surgery for patients who might otherwise require an operating room. It is performed at the slit lamp without capital equipment.

In the platform's first-in-human series, 11 eyes with mild, moderate and advanced glaucoma were treated with OBi Core by three surgeons. No device- or procedure-related adverse events were observed, and early postoperative intraocular pressures ranged from the single digits to the low teens. Additional clinical series are being compiled, and the company's first clinical studies are underway in Canada.

"Everywhere we operated on mission, the patients were there and the operating room was not," said Dr. Shoham-Hazon. "When glaucoma surgery can be performed safely at a slit lamp, it changes who can treat this disease, and where. This season we are putting our instruments directly into surgeons' hands."

Over the coming weeks, Hexiris will be present at five major meetings:

Ophthalmology Futures Forum, London, September 10. Dr. Shoham-Hazon presents the Hexiris platform and first-in-human results to the forum's audience of ophthalmic innovators, clinicians and investors.

ESCRS Annual Congress, London, September 11 to 15. Hexiris will be present at the 44th Congress of the European Society of Cataract and Refractive Surgeons.

Canadian Glaucoma Society Meeting, end of September, Halifax, September 19 to 20. Hexiris will host hands-on OBi demonstrations for the Canadian glaucoma community.

57th Sally Letson Symposium, Ottawa, September 24 to 26. Under this year's theme, Reimagining Glaucoma Care Together, Hexiris will host hands-on OBi training for attending surgeons.

AAO 2026, New Orleans, October 9 to 12. Hexiris will showcase the OBi platform and host hands-on demonstrations at the American Academy of Ophthalmology Annual Meeting.

These meetings come as Hexiris prepares for the planned commercial introduction of OBi Core and OBi Gon in select markets in early 2027, subject to applicable regulatory requirements.

• Phase 2 eDREAM data will examine the feasibility of patient-tailored microperimetry as a sensitive functional endpoint for evaluating GAL-101 in geographic atrophy
• Baseline analyses will explore microperimetry repeatability, structure–function discordance, and agreement between fundus autofluorescence and OCT measurements

Galimedix Therapeutics announced that functional feasibility data from its phase 2 eDREAM study evaluating GAL-101 in geographic atrophy (GA), will be presented at the 26^th Euretina Congress. The congress will take place October 1-4, 2026 in Vienna, Austria. The data will showcase the use of patient-tailored microperimetry as a sensitive functional endpoint for evaluating potential treatment effects in the eDREAM study.

The following abstract will be presented by Galimedix:

Oral presentation #1:
Title: Repeatability and Test–Retest Characteristics of Personalized Microperimetry Endpoints in Non-Foveal Geographic Atrophy: Findings from Baseline Triplicate Testing in the eDREAM Trial
Presenter: Yaniv Barkana, MD, Chief Medical Officer, Galimedix
Time/Place: Sunday, October 4 | 12:00-12:06 CEST | Free Paper Forum 1

Other abstracts analyzing baseline data from eDREAM will be presented during the conference:

Oral presentation #2:
Title: Structure–Function Discordance in the Peri-Atrophic Zone of Geographic Atrophy: Baseline Results from the eDREAM Trial
Presenter: Omer Trivizki, MD, MBA, Unit & Deputy Chair of Ophthalmology at Tel-Aviv Medical Center, eDREAM International Coordinating Investigator
Time/Place: Thursday, October 1 | 13:24-13:30 CEST | Free Paper Forum 2

Oral presentation #3:
Title: Cross-modal agreement between FAF and OCT in quantification of geographic atrophy for eyes enrolled in the eDREAM randomised trial
Presenter: Fangyao Tang, Moorfields Ophthalmic Reading Centre & Clinical AI Lab
Time/Place: Friday, October 2 | 16:54-17:00 CEST | Free Paper Forum 1

Oral presentation #4:
Title: Topographic Spatial Agreement Between Fundus Autofluorescence and SD-OCT Features of Geographic Atrophy: Analysis in the eDREAM Trial
Presenter: Yiu Wai Chan, Moorfields Ophthalmic Reading Centre & Clinical AI Lab
Time/Place: Saturday, October 3 | 9:42-9:48 CEST | Free Paper Forum 2

E-Poster #1:
Title: Repeatability and Correlation of Best-Corrected Visual Acuity, Low-Luminance Visual Acuity, and Central Foveal Microperimetry: Baseline Paired-Visit Data from the eDREAM Trial
Presenter: Omer Trivizki, MD, MBA, Unit & Deputy Chair of Ophthalmology at Tel-Aviv Medical Center, eDREAM International Coordinating Investigator
Time/Place: Thursday, October 1| Poster Hub

E-poster #2:
Title: Locus-level test-retest repeatability of MAIA microperimetry in geographic atrophy: implications for trial endpoint design from the eDREAM randomised trial
Presenter: Dun Jack Fu, Moorfields Ophthalmic Reading Centre & Clinical AI Lab
Time/Place: Thursday, October 1 | Poster Hub

• Researchers at Duke University developed an AI system designed to determine the optimal treatment timing for patients converting to wet AMD.
• The team found the system’s precision and specificity were particularly strong, reducing false-positive treatment recommendations compared with the baseline models.
• The study was limited by its small single-center dataset and retrospective design, and further studies and additional validation are necessary.

Researchers at Duke University have developed a fully automated AI system designed to determine the optimal treatment timing for patients converting to wet AMD. The study found that the deep-learning framework could predict when anti-VEGF treatment should be initiated while also measuring changes in outer retinal thickness.¹

The study included 122 patients (n = 207 eyes) with intermediate AMD and 2,047 OCT images collected at the Duke Eye Center between January 2006 and November 2020. Researchers divided the data into two datasets to train different components of the AI framework.¹

The modular, multitask, and multimodality deep-learning system consisted of a convolutional neural network to extract the necessary OCT features, and two models to predict treatment initiation and estimate future retinal thickness changes for patients who acutely converted to wet AMD.¹

When evaluated against overall clinical treatment decisions made by retina specialists, the model achieved an area under the receiver operating curve (AUROC) of 0.73, accuracy of 0.87, precision of 0.73, sensitivity of 0.69, and specificity of 0.92. Under a separate single-visit assessment, the framework achieved an AUROC of 0.88, accuracy of 0.89, precision of 0.89, sensitivity of 0.62, and specificity of 0.98.¹

The study found that the AI system’s precision and specificity were particularly strong, reducing false-positive treatment recommendations compared with the baseline models. The authors noted that while some baseline models achieved slightly higher sensitivity, they generated more false positives, potentially leading to unnecessary treatment recommendations.¹

In addition to predicting treatment initiation, the framework estimated future outer retina thickness measurements with a normalized mean absolute error of 11.99%.¹

The authors said the technology may one day be integrated into clinical workflows as a decision-support tool, emphasizing that any recommendations would supplement, not replace, clinician judgment. The study was limited by its small single-center dataset and retrospective design. The researchers also noted that treatment labels were based on real-world clinical decisions rather than standardized image grading protocols. Further studies and additional validation would be necessary before clinical implementation.¹

1. Gao Q, Kuo D, Amason J, et al. Modular multi-task deep learning framework for prediction of treatment initiation in neovascular age-related macular degeneration modular AI for NVAMD treatment initiation study-MANTIS [published online ahead of print September 1, 2026). Br J Ophthalmol. doi.org/10.1136/bjo-2025-328327

• Staar Surgical's global analysis found declining or stagnant laser procedure volumes alongside increasing adoption of phakic IOLs across multiple refractive surgery markets
• Patient attitudes may be contributing to the trend, with 59% of surveyed consumers reporting they were not open to laser correction and 58% expressing interest in a reversible option
• Asian markets currently lead phakic IOL adoption, while lower awareness in the United States and Europe may leave room for further growth in implantable lens correction

Staar Surgical has released a global market analysis suggesting refractive surgery is undergoing a gradual shift from laser-based procedures toward implantable lens correction, with changing patient preferences and evolving clinical practice patterns contributing to increased adoption of phakic IOLs.

The report, The Future of Refractive Surgery, examines patient sentiment, procedure trends and clinical practice patterns across Japan, China, South Korea, the United States, Germany, Spain, and the UK and Ireland. The analysis incorporates a consumer survey of 7,800 respondents as well as data from academic research.¹

According to Staar, the findings point to a consistent increase in implantable lens correction across multiple markets, including regions where awareness of ICL technology remains relatively low. The company, which manufactures the Evo family of Implantable Collamer Lenses (Evo ICL), is presenting the report as evidence of structural changes affecting both patient demand and refractive surgery practice.

The report found that excimer laser procedure volumes have declined or remained stagnant across the geographic regions examined, while phakic IOL adoption has increased.

The US market showed one of the largest divergences. According to the report, US laser procedure volume has declined 52% since 2022, representing 4 consecutive years of double-digit decreases. During the same period, adoption of Evo ICL increased 76%, which Staar said has more than tripled the technology's market share. Patient attitudes may provide an indication of how the refractive market will develop, according to the analysis.

Among consumers surveyed globally, 80% said they would like to be free from glasses and contact lenses, while 58% said they were attracted to a vision-correction option that is reversible. The survey also found that 59% of respondents were not open to laser vision correction.

Safety concerns and fear of the procedure were each identified by 38% of respondents as barriers to laser correction, compared with 32% who cited cost.

Japan offers a view of a lens-based refractive market

Staar highlighted Japan as the most developed market for lens-based vision correction among those included in the report. ICL procedures now account for more than half of refractive procedures in the country, according to the analysis.

Consumer awareness also differs from that observed in Western markets. In Japan, 46% of respondents demonstrated unaided awareness of ICL, compared with 40% for LASIK.

Awareness of implantable lens correction remains substantially lower in several markets that Staar identified as being at an earlier stage of the same transition. Awareness was reported at 18.9% in Germany, 19.3% in the United States, 20% in the UK and Ireland, and 27% in Spain.

The company said changes in how patients research refractive procedures may contribute to future adoption patterns. Patients increasingly obtain information through search engines, social media, online communities and artificial intelligence tools in addition to consultations with eye care professionals.

In the United States, 53.5% of surveyed consumers said they would use search engines to investigate vision correction, and 25.5% said they would use AI tools such as ChatGPT.

Changes in surgeon practice appear to be occurring alongside shifts in patient sentiment.

Staar cited an AECOS study involving 1,882 eyes treated at 19 US practices in which ICL implantation accounted for 72% of refractive procedures performed in patients with myopia of -8.0 D or greater.²

The company suggested that expanding surgeon training and familiarity with phakic IOL implantation could further increase consideration of lens-based correction for appropriate patients.

Long-term demographic trends may also expand the potential patient population. Global prevalence of high myopia, defined in the report as -6.0 D or greater, is projected to approach 1 billion people by 2050, with particularly large populations in East and Southeast Asia.³ According to the report, phakic IOLs have more than quadrupled their share of global refractive procedures during the past decade while laser procedure volumes have remained broadly flat.

Staar representatives will discuss the report during the 44th Congress of the European Society of Cataract and Refractive Surgeons (ESCRS), scheduled for September 11 to 15, 2026, in London.

References

1. STAAR Surgical Consumer Survey, Global Combined Summary (n=7,800). Fieldwork: March 2025 (UK), August 2025 (US), March 2026 (Germany, Spain), May 2026 (China, Japan, South Korea).
2. AECOS US Refractive Surgery Study Data 2024, n=1,882 procedures, Internal Data on File.
3. Holden BA, Fricke TR, Wilson DA, et al. Global prevalence of myopia and high myopia and temporal trends from 2000 through 2050. Ophthalmology. 2016

• The AT LUCIA Toric 721P (Carl Zeiss Meditec) is a bitoric hydrophobic monofocal IOL with a nonconstant asphericity profile design.
• The company announced the launch of the new lens at 2026 European Society of Cataract and Refractive Surgeons congress in London.
• The AT LUCIA Toric 721P has CE marked and is commercially available in select European countries, including Germany, Italy, Spain, Portugal, and France.

Zeiss Medical Technology announced the commercial availability of the Zeiss AT Lucia toric 721P, a hydrophobic monofocal toric IOL with a bitoric optic combined with an asphericity design. Built to perform independently of individual eye conditions, the Zeiss Lucia family of lenses takes into account variations in pupil size, corneal spherical aberration, and natural lens position to offer consistent, reliable outcomes in real-world conditions.

The AT LUCIA toric 721P IOL, CE marked and commercially available in select European countries, including Germany, Italy, Spain, Portugal, and France, officially launched at the European Society of Cataract and Refractive Surgeons (ESCRS) congress in London from September 11 – 14.

“ZEISS once again demonstrates to the market our expertise in optics with a huge leap forward for our IOL offerings. Our broader portfolio will provide surgeons around the world with more options to reach a higher level of patient satisfaction,” says Andreas Völker, Head of the Ophthalmology Strategic Business Unit, Zeiss Medical Technology.

“Providing high reliability and proven lens platform stability, the Zeiss AT LUCIA toric 721P is a game changer, enabling surgeons to elevate their astigmatism management workflow,” says Frank Seitzinger, Head of Business Sector Surgery Anterior Segment, Zeiss Medical Technology.

During the launch celebration in the Zeiss booth (C.100 in the South Event Hall) on Saturday, September 12 from 10:00 – 11:00 AM BST, attendees will hear from surgeons who participated in early clinical evaluations with the IOL and who will share first-hand insights from their use. Participating surgeons include Prof. Gerd Auffarth from Heidelberg University Hospital (Germany), Dr. Andrea Janeková from Eye Centre Prague (Czech Republic), Dr. Amin Kassem from Värnamo Ögoncenter (Sweden), Dr. Fayyaz Musa from The Eye Doctor Clinic (UK), Dr. Helena Noguera from Miranza COI (Spain), Dr. Felix Rombold from Südblick Augenzentren (Germany), and Prof. Sathish Srinivasan from Ayrshire Eye Clinic (UK), who are also receiving the “Zeiss AT Lucia Toric Pioneer Award” for their pioneering role in adopting the new IOL technology.

Johnson & Johnson has appointed Jacqueline Henderson Company Group Chair, Vision, effective immediately. Ms. Henderson has served as Interim Company Group Chair for the past 3 months, leading the company’s end-to-end global vision business across Vision Care and Surgical Vision. Before taking on the interim role, she served as President, EMEA, Vision. 

"With more than 30 years at Johnson & Johnson, Ms. Henderson brings enterprise perspective, extensive global leadership experience and deep expertise in strategy, marketing, commercial leadership, brand building, e-commerce and digital transformation," J&J said in a company statement. "In her new role, Ms. Henderson will continue to advance innovation and commercial execution for a business whose products and technologies help make vision possible for more than 40 million people around the world each year." 

• The FDA has accepted and filed Nanoscope Therapeutics’ BLA for Mogenry, an investigational optogenetic gene therapy for patients with RP and severe vision loss
• The application is supported by phase 1/2a and phase 2b/3 data, with RESTORE meeting its primary and key secondary endpoints and showing visual acuity improvements at weeks 52 and 76
• If approved, Mogenry could become the first gene-agnostic therapy to improve vision in patients with RP and severe vision loss, with a one-time, in-office administration approach that does not require genetic testing

The FDA has accepted and filed Nanoscope Therapeutics’ biologics license application (BLA) for Mogenry (sonpiretigene isteparvovec; MCO-010), an investigational optogenetic gene therapy designed to restore vision in patients with retinitis pigmentosa (RP) and severe vision loss.

The regulatory milestone moves the one-time therapy into FDA review. If approved, Mogenry would become the first gene-agnostic therapy to improve vision in patients with RP and severe vision loss, according to Nanoscope.

"FDA acceptance and filing of our BLA for MOGENRY is a crucial milestone that brings us a critical step closer to offering a one-time, in-office treatment option to the retinitis pigmentosa community with severe vision loss, who have no approved therapy today," said Sulagna Bhattacharya, Chief Executive Officer of Nanoscope Therapeutics. "The strength of our RESTORE data, together with the durability we have observed through long-term follow-up in the REMAIN study, give us confidence in MOGENRY's potential to become a new standard of care for patients living with RP having severe vision loss. We look forward to working closely with the FDA throughout its review."

The FDA has issued a PDUFA (Prescription Drug User Fee Act) date in the first half of 2027. Nanoscope told Eyewire News it is actively preparing to be commercial-ready in the first half of 2027. 

The application is supported by efficacy and safety findings from a Phase 1/2a study (NCT04919473) and the phase 2b/3 RESTORE trial (NCT04945772). RESTORE was a multicenter, randomized, double-masked, sham-controlled clinical trial evaluating Mogenry in patients with RP and severe vision loss. According to Nanoscope, the trial met its primary and key secondary endpoints, demonstrating improvements in visual acuity at weeks 52 and 76.

The investigational therapy was also reported to be well tolerated, with no treatment-related serious adverse events.

Most patients treated in RESTORE subsequently continued into the REMAIN study, which is providing long-term follow-up data included in the BLA.

Allen C. Ho, MD, professor of ophthalmology at Thomas Jefferson University, director of retina research at Wills Eye Hospital, and chief medical advisor for Nanoscope Therapeutics, said the therapy’s potential accessibility could be particularly important for patients outside major academic centers.

“Mogenry does not require genetic testing or administration in a surgical suite, which could enable broad adoption by community retina practices,” Dr. Ho said in the company’s announcement.

Mogenry is designed to address vision loss through optogenetics rather than targeting a particular disease-causing mutation. The approach is intended for patients who have experienced photoreceptor loss from retinal degeneration. That distinction could potentially broaden the population eligible for treatment compared with mutation-specific gene therapies because patients would not need to have a particular genetic variant to qualify.

Nanoscope is also positioning the therapy as a one-time, in-office treatment, potentially avoiding the surgical-suite administration required for some ocular gene therapies.

• All 5 participants in the low-dose BIRD-1 cohort demonstrated clinically meaningful improvement in at least 1 measure of visual function, while structural improvements were observed in 4 participants
• OPGx-BEST1 was reported to have a favorable safety profile, with no serious adverse events in Cohort 1
• Opus Genetics has advanced to a higher-dose cohort and is preparing for potential pivotal development, with Phase 3 participant dosing targeted to begin in 2027

Opus Genetics announced positive 3- and 6-month results from the low-dose cohort of its ongoing phase 1/2 BIRD-1 clinical trial evaluating OPGx-BEST1 in patients with BEST1-related retinal diseases, including Best vitelliform macular dystrophy (BVMD) and autosomal recessive bestrophinopathy (ARB).

According to the company, all 5 participants in Cohort 1 demonstrated clinically meaningful improvement in at least 1 measure of visual function after receiving OPGx-BEST1 at a dose of 1.5 × 10⁹ vg/eye. Structural improvements were also observed in 4 of the 5 participants.

Cohort 1 included 3 participants with BVMD who have reached 3 months of follow-up and 2 participants with ARB who have reached 6 months. Opus Genetics said the largest functional gains occurred among participants with less advanced disease and viable retinal tissue, a finding that could help guide patient selection in subsequent development.

“These positive results provide important evidence of OPGx-BEST1’s potential to improve both visual function and retinal structure in patients with BEST1-related retinal disease, which we believe has a significantly larger underserved patient population than we previously thought,” George Magrath, MD, chief executive officer of Opus Genetics, said in a statement.

Dr. Magrath added that the Cohort 1 findings, along with recent discussions with the FDA and enrollment in Cohort 2, support the company’s plans to move the program toward pivotal development in 2027.

All 5 participants experienced clinically meaningful improvement in 1 or more assessments of visual function, including best-corrected visual acuity (BCVA), low-luminance visual acuity (LLVA), contrast sensitivity, and microperimetry. BCVA improved in 3 of 5 participants (60%), while LLVA and contrast sensitivity each improved in 2 of 5 participants (40%). Among participants evaluable by microperimetry, 3 of 4 (75%) demonstrated clinically meaningful improvements in retinal sensitivity.

According to Opus Genetics, microperimetry gains were concentrated in the treated retinal pigment epithelium transitional zone, where viable photoreceptors remained. The greatest functional improvements were seen in participants with less advanced disease.

Structural changes were reported in 4 of 5 participants. Among the 3 participants with BVMD, 2 (67%) experienced reductions in vitelliform material. The third participant had a possible but not definitive reduction. Both participants with ARB experienced reductions in intraretinal fluid.

The company noted that vitelliform material is a defining structural feature of BVMD and said its reduction corresponded with functional improvement in the responding participants. In ARB, where intraretinal fluid is a predominant structural manifestation, reductions were observed in both treated participants.

OPGx-BEST1 demonstrated what the company characterized as a favorable safety and tolerability profile. No serious adverse events, dose-limiting toxicities, or intraocular inflammation were reported, and there were no notable vital-sign or safety-laboratory findings. All treatment-related adverse events were mild or moderate in severity.

Based on the Cohort 1 findings, Opus Genetics has advanced BIRD-1 into Cohort 2, which is evaluating a higher dose of 4.5 × 10⁹ vg/eye.

Although Cohort 2 was initially designed to enroll 5 participants, the company said it has over-enrolled the cohort with 8 participants, most of whom have BVMD. Dosing is expected to be completed during the fourth quarter of 2026, with topline 3-month results anticipated in the second quarter of 2027. Six-month data for the 3 Cohort 1 participants with BVMD are also expected in the second quarter of 2027.

Opus Genetics also provided additional details about an August 2026 meeting with the FDA regarding the clinical development of OPGx-BEST1 and potential endpoints for a pivotal trial. According to the company, discussions with the agency identified a potential pivotal endpoint based on an improvement of at least 3 dB from baseline by microperimetry in at least 5 prespecified loci, in conjunction with a patient-reported outcome in a randomized, controlled trial. BCVA, LLVA, and contrast sensitivity may also represent acceptable endpoints, the company said.

Opus said it also reached alignment with the FDA regarding phase 3 and commercial manufacturing requirements, which it expects to complete in early 2027. The company plans to begin phase 3 planning immediately, with participant dosing targeted for 2027.

Separately, Opus reported new epidemiologic estimates suggesting the population potentially affected by symptomatic BEST1-related disease may be larger than previously estimated.

Research conducted by Triangle Insights Group, based on a survey of more than 150 eye care professionals, estimated approximately 23,600 symptomatic patients with BEST1-related disease in the United States. The estimate includes approximately 13,000 diagnosed and 10,600 undiagnosed patients. Globally, the research estimated approximately 45,400 symptomatic patients with BEST1-related disease.

• The AMA has adopted a resolution supporting classification of myopia as a disease, including recognition by CMS, as part of an effort to improve treatment access and insurance coverage
• Specialized spectacle lenses, contact lenses, orthokeratology, low-dose atropine and increased outdoor time are among approaches being studied or used to address childhood myopia onset or progression
• Growing concern about the long-term ocular risks associated with high myopia is driving calls for greater public education, childhood screening and access to early intervention

The American Medical Association (AMA) has adopted a resolution supporting the formal classification of myopia as a disease, adding momentum to efforts to improve access to myopia management for children and adolescents, according to a news release from the American Academy of Ophthalmology. 

The resolution calls for myopia to be recognized as a disease, including by the Centers for Medicare and Medicaid Services, with the goal of improving access to appropriate treatment and insurance coverage. It also supports expanded public health education and improved childhood screening. The policy comes as ophthalmic organizations increasingly emphasize that myopia is more than a refractive error corrected with glasses or contact lenses. Progressive and high myopia can increase the lifetime risk of sight-threatening ocular complications.

The American Academy of Ophthalmology (AAO) has advocated for greater recognition of the condition as a public health issue. In 2021, the Academy published the white paper, Reducing the Global Burden of Myopia by Delaying the Onset of Myopia and Reducing Myopic Progression in Children, calling for international collaboration, education and strategies aimed at delaying myopia onset and slowing progression.

Myopia prevalence in the United States has increased substantially over recent decades. According to figures cited by the Academy from the National Eye Institute, approximately 41.6% of Americans are nearsighted. Globally, projections have suggested that approximately half of the world's population could have myopia by 2050 if current trends continue.

The implications extend beyond dependence on corrective lenses. High myopia is associated with increased risks of retinal detachment, glaucoma, cataract and myopic maculopathy, potentially resulting in irreversible vision loss.

A growing body of research has examined interventions intended to delay myopia onset or reduce progression during childhood. Approaches include specialized spectacle lenses, soft multifocal or dual-focus contact lenses, orthokeratology, low-dose atropine and increased time outdoors.

Specialized spectacle lenses designed for myopia management have emerged as one option for children. Soft contact lenses employing multifocal or dual-focus optical designs also can reduce myopia progression in appropriately selected pediatric patients.

Low-dose atropine has also been studied extensively for childhood myopia management. Treatment response can vary according to concentration and population, and studies have reported differences in efficacy among geographic and ethnic groups, according to the AAO.

Increasing children's time outdoors represents another important strategy, particularly for reducing the risk of myopia onset. Evidence has linked greater outdoor exposure with a lower incidence of childhood myopia.

Despite the expanding range of interventions, the Academy said awareness among parents, educators and policymakers remains limited. Insurance coverage can also present a barrier because interventions intended to slow myopia progression may not be routinely covered.

The Academy is also supporting federal legislation intended to improve children's access to vision screening and follow-up care. H.R. 2527, the Early Detection of Vision Impairments for Children Act, seeks to establish a national approach to children's vision and eye health.

• VirtuaLens has added a Mix and Match feature that allows surgeons to simulate different IOL technologies in each eye for cataract patients before surgery
• A new "Monovision Dominance Invert" function lets patients compare monovision configurations by switching simulated eye dominance during a consultation

VirtuaLens announced the launch of its new Mix and Match feature for the company’s immersive virtual reality patient education platform, expanding surgeons’ ability to demonstrate personalized IOL strategies to patients considering cataract surgery.

The VirtuaLens platform and headset are designed to simulate the visual differences among IOL options before surgery, giving patients an immersive way to experience potential postoperative vision rather than relying solely on traditional educational materials.

With the Mix and Match software update, surgeons can assign different types of IOLs to each eye to demonstrate treatment approaches intended to optimize vision across multiple distances. For example, physicians can simulate a multifocal IOL in one eye and an extended depth of focus (EDOF) IOL in the other, as well as other combinations involving different IOL technologies.

The update also includes a Monovision Dominance Invert function, which allows surgeons to switch eye dominance during a consultation. According to the company, the capability enables patients to compare different monovision configurations and gain a better understanding of how each approach could affect their everyday vision.

The additions are intended to address a patient education challenge that has become increasingly relevant as cataract treatment strategies become more individualized. When surgeons combine different premium IOL technologies between the 2 eyes, explaining the potential benefits and trade-offs through brochures or 2-dimensional videos can be difficult, according to VirtuaLens.

VirtuaLens said its immersive simulations are designed to make those concepts easier for patients to visualize while supporting individualized discussions between surgeons and patients about their treatment options.

Alongside the software update, VirtuaLens introduced a Mix and Match Vision Tutorial to help surgeons, technicians, and other practice staff learn to use the new functionality. The guided tutorial provides an overview of the feature and is intended to support practices as they incorporate the technology into patient consultations.

• Johnson & Johnson will host and participate in peer-to-peer educational programs at ESCRS 2026 covering refractive surgery, presbyopia treatment, cataract care, IOL selection, and biometry
• Investigator-initiated and independent studies will present clinical data on the Tecnis IOL portfolio, including Tecnis Odyssey, Tecnis PureSee, and Tecnis Eyhance, across patient populations and surgical settings

To support ophthalmologists in optimizing patient outcomes and advancing clinical practice, Johnson & Johnson will host and participate in a series of peer-to-peer educational programs featuring leading ophthalmic surgeons and key opinion leaders throughout the 2026 European Society of Cataract and Refractive Surgery (ESCRS) Congress, September 11-15 in London.

"Through symposia, expert panel discussions, case-based learning and interactive sessions, attendees will gain insights into the latest evidence, technologies and real-world clinical experiences across refractive surgery, presbyopia treatment and cataract care", said Lisa Ann Hill, President EMEA, Vision, MedTech, Johnson & Johnson. "Investigator initiated data will also be presented at ESCRS reflecting the growing body of clinical evidence supporting the TECNIS IOL portfolio across a range of patient needs."

Peer-to-Peer Education Events  

Johnson & Johnson is hosting and participating in educational sessions with key opinion leaders throughout the meeting: 

Saturday, September 12:

• 10:30-11:00: Meet the Experts: Real Cases, Real Choices: The Truth Behind Tecnis Odyssey IOL
  • ExCeL Exhibition Centre, London - Booth E.200
  • Expert perspectives on optimizing clinical outcomes with Tecnis Odyssey IOL. Three experienced surgeons will share their strategies for patient selection, decision making, and real-world case insights, with the session moderated by an expert surgeon to ensure an interactive discussion for the audience.
• 13:00-14:00: Lunch Symposia: Advancing Full Range of Vision: Evidence, Experience and Outcomes with Tecnis Odyssey IOL
  • ExCeL Exhibition Centre, London - Level 3 Victoria Room 5/6
  • Valuable opportunity to explore Tecnis Odyssey IOL - through the personal clinical experiences of leading ophthalmic surgeons, moderated by Prof. Oliver Findl
• 15:30-16:00: Meet the Experts: The Art of Precision: Tecnis PureSee IOL Through Expert Eyes
  • ExCeL Exhibition Centre, London - Booth E.200
  • Expert perspectives on optimizing clinical outcomes with Tecnis PureSee IOL. Experienced surgeons share their strategies for patient selection, surgical planning, and real-world case insights. The session concludes with an interactive Q&A.

Sunday, September 13:

• 8:30-10:00: ESCRS European Clinical Spotlight Symposium Session 2026: Multicentric Randomized Clinical Trial comparing the refractive Extended Depth of focus IOL, Tecnis PureSee, vs an aspheric monofocal control, Tecnis 1 piece IOL
  • ExCeL Exhibition Centre, London - ICC Auditorium
  • Presentation will reinforce clinical trial data, demonstrating the clinical safety and effectiveness of the Tecnis PureSee IOL
    • A sub-group analysis will be shared showing results of subjects with absolute post-op spherical equivalent (SEQ) > 0.25 D in one or both eyes to assess the tolerance of the study IOL to post op refractive error
       
• 10:30-11:00: Meet the Experts: SILK in Action: See It. Learn It. Master It.
  • ExCeL Exhibition Centre, London - Booth E.200
  • Learn about the SILK procedure, from surgical technique and pre-operative planning, to learning curve management and real-world case insights from experienced surgeons.
     
•  13.00-14.00: Lunch Symposia: From Enhanced to Extended: Shaping the Modern IOL Spectrum
  • ExCeL Exhibition Centre, London - Level 3 - George V Room 4
  • Valuable opportunity to explore Tecnis Eyhance IOL & Tecnis PureSee IOL — through the personal clinical experiences of leading ophthalmic surgeons, moderated by Dr. Ahmed Assaf
• 15:30-16:15: Biometry Excellence Master Class
  • ExCeL Exhibition Centre, London - Booth E.200
  • This Biometry Excellence Master class translates biometry science into actionable steps to consistently achieve more predictable, patient‑satisfying results. During this session our experts will share practical guidance on formula selection and plausibility checks to reduce refractive surprises, particularly in short, long and complex eyes.

Johnson & Johnson is also proud to support the ESCRS Corneal and Lens-Based Refractive Surgery Masterclass, a new global educational initiative designed to help develop the next generation of refractive surgeons. Combining expert mentorship, virtual learning, case-based discussions and hands-on training, the programme provides early-career ophthalmologists with the knowledge and skills to advance excellence in refractive patient care.

Notable findings for the TECNIS Family of IOLs: 

Tecnis IOLs are prominently featured across papers and posters at ESCRS, with highlighted Investigator Initiated Studies demonstrating strong, high‑quality visual outcomes, including in post‑LASIK patient populations and refractive lensectomy.

• Visual And Refractive Outcomes of an EDOF Intraocular Lens in Post-Lasik Eyes Vs Non-Lasik Controls: A Real-World Retrospective Comparison – Presented by: Dr. David Mingo Botín*
• Patients achieved a high level of visual acuity and refractive outcomes Tecnis 
  • Refractive accuracy showed that 93% of post-LASIK eyes and 77% of control eyes were within ±0.50 
  • Monocular UDVA 20/24 (0.07) in the post-LASIK group versus 20/23 (0.05) in controls
• Prospective Evaluation Of Visual And Refractive Outcomes With TECNIS PureSee IOL (Partial Dofi-Ex) Intraocular Lens – Presented by: Dr Clare O'Donnell on behalf of Dr Alise Kalteniece*
  • This study reports the visual and refractive outcomes of TECNIS PureSee IOL intraocular lens implanted bilaterally following refractive lensectomy
    • Mean binocular UDVA was 20/19 (-0.02), binocular UIVA was 20/27 (0.14)
    • All respondents reported improved postoperative scores in Catquest-9SF questionnaire 
• Visual And Functional Outcomes of the TECNIS Odyssey Full-Dofi Intraocular Lens – Presented by: Dr. Nic J. Reus*
  • Bilateral implantation of TECNIS Odyssey IOL demonstrated a continuous range of high-quality vision across all distances
    • Binocular UDVA and CDVA were both 20/14 (-0.16)
    • Binocular UIVA and DCIVA were 20/21(0.02) and 20/17 (-0.06), respectively
    • Binocular UNVA and DCNVA were 20/19 (-0.02) and 20/18 (-0.04), respectively
• Clinical Outcomes of a New Full Range Diffractive Intraocular Lens – Presented by: Dr. Helena Noguera Nuñez*
  • TECNIS Odyssey IOL demonstrated strong visual outcomes across far, intermediate, and near distances, with good refractive performance and high patient satisfaction
    • Mean CDVA and DCIVA at 3 months were 20/20 (0.0)
    • DCNVA was 20/25 (0.1)
• Comparison Of Vision, Spectacle Independence and Patient Satisfaction with Micro-Monovision Implantation of Two Toric Aspheric Intraocular Lenses in the Public Health Sector: Final Results of a Prospective Randomized Controlled Study – Presented by: Dr. Ashmal Jameel and Prof David O’Brart*
  • Eyhance Toric IOL showed greater spectacle independence, compared to Acrysof IQ Toric
  • 65% of TECNIS Eyhance IOL patients versus 20% of Acrysof IQ patients reported independence from glasses, despite similar distance vision between groups

TECNIS IOLs will also be featured via independent studies:

• Visual Outcomes After Bilateral TECNIS PureSee IOL Implantation in Refractive Lens Exchange Patients with Ocular

Morbidities: A Multicentre Retrospective Cohort Study – Presented by: Dr. Frank Kerkhoff

• Enhancement Rates Across Full Range Of Focus IOL Platforms – Presented by: Dr. Frank Kerkhoff
• Visual And Refractive Outcomes Following Implantation of a Refractive Partial Range of Field Extended Intraocular Lens in Eyes with a History of Previous Laser Refractive Surgery – Presented by: Dr. Richard Mcneely

• Norlase is moving to a hybrid sales and support model in the UK, with Hanson Instruments continuing to serve NHS clinics and Norlase directly supporting private practices and clinic chains
• Heather Robbins has been appointed national sales director, UK, bringing more than 19 years of ophthalmic and medical device sales experience
• Norlase will showcase its Lynx Pattern LIO and Echo Pattern Laser at ESCRS 2026 in London

Norlase has announced a transition to a hybrid sales and support model in the United Kingdom, appointing Heather Robbins as national sales director, UK, to oversee the ophthalmic laser manufacturer’s private sector business.

Under the new structure, Norlase’s existing distribution partner, Hanson Instruments, will continue serving National Health Service (NHS) clinics. Ms. Robbins will lead direct sales and support for private practices and clinic chains.

Norlase said the model is intended to combine its partner’s local distribution capabilities with an expanded direct presence as adoption of the company’s retina and glaucoma laser platforms grows in the UK.

“Adopting a hybrid sales model in the UK builds on the momentum we’ve created across Europe,” Oliver Hvidt, CEO and co-founder of Norlase, said in a news release. “By partnering with Hanson to serve NHS clinics while establishing a direct line for private accounts and clinic chains, we can better support the unique needs of UK retina and glaucoma specialists.”

Ms. Robbins brings more than 19 years of ophthalmic and medical device sales experience to the position. She spent 15 years at Optos, most recently serving as regional sales manager for Southwest England and Southern Wales. She previously worked as a territory manager at Allergan, focusing on the company’s glaucoma portfolio.

The company said the new structure is also intended to provide more consistent hands-on service, training, and clinical support to UK ophthalmologists. Norlase noted that the approach extends a strategy of developing a direct, in-market presence that has supported its growth in the United States.

Ms. Robbins will join Mr. Hvidt and Norlase’s international team at the 44th Congress of the European Society of Cataract and Refractive Surgeons (ESCRS), scheduled for September 11 to 15, 2026, in London.

At the meeting, Norlase will showcase its Lynx Pattern LIO and Echo Pattern Laser and host educational presentations addressing pattern laser trabeculoplasty and vitreoretinal examination before cataract surgery.

• Alcon will showcase cataract surgery technologies at ESCRS 2026, including Clareon PanOptix Pro, the European launch of Clareon TruPlus, and the Unity Cataract System
• New clinical and bench data will examine Clareon PanOptix Pro visual and optical performance and Unity system metrics including phaco efficiency, ultrasound energy delivery, anterior chamber stability, and surgical workflow
• Alcon’s broader ESCRS program will feature technologies spanning cataract, refractive, and glaucoma care, with nearly 40 studies and abstracts scheduled for presentation

Alcon will present its latest surgical innovations at the 44th Congress of the European Society of Cataract and Refractive Surgeons (ESCRS) in London, September 11-15, 2026. Alcon will showcase a portfolio of surgical innovations designed to meet the evolving needs of a growing cataract patient population, including Clareon PanOptix Pro, the European launch of Clareon TruPlus, and the Unity Cataract System (CS). Together, these innovations advance IOL performance and drive greater efficiency across the cataract surgery workflow.

Alcon will also feature innovations across cataract, refractive, and glaucoma care, including Unity M microscope, WaveLight Plus, Voyager Direct Selective Laser Trabeculoplasty (DSLT) and Hydrus Microstent. Nearly 40 studies and abstracts will also be featured throughout the congress.

“Surgeons today are being asked to deliver outstanding outcomes for more patients, with greater efficiency and consistency than ever before,” said Seba Leoni, President Surgical at Alcon International. “That is why our innovation strategy is focused not only on breakthrough technologies, but on how they work together in real clinical settings. At ESCRS 2026, Clareon PanOptix Pro and Unity Cataract System (CS) showcase Alcon’s commitment to advancing the next generation of cataract surgery—from optical performance and visual quality to operating room (OR) workflow and superior procedural efficiency.”

Clareon PanOptix Pro: advancing optical performance across the full visual range

Building on the Clareon platform and the established Clareon PanOptix clinical profile, including its superior axial stability and low visual disturbances, Clareon PanOptix Pro is designed to provide more uninterrupted light distribution across the full visual range, according to Alcon. It delivers an unprecedented 94% light utilization for reduced light scatter—the highest reported of any trifocal IOL and is designed for better image contrast.

New data presented at ESCRS 2026 will further characterize Clareon PanOptix Pro’s visual performance, patient-reported outcomes and optical quality:

• Dr. David Gunn will present the first prospective real-world evaluation of binocular visual performance and patient-reported outcomes following bilateral implantation of Clareon PanOptix Pro. E-Poster, On Demand
• A study by Dr. William Xu, presented by Dr. Kamal Das, will showcase bench data and virtual implantation (JenVis) comparing Clareon PanOptix Pro and TECNIS Odyssey , with findings supporting the optical performance of Clareon PanOptix Pro in the intermediate-to-near range, including image contrast and tolerance of halo and starburst. Poster, Podium 3
• Dr. Andrzej Dmitriew will present bench data evaluating the optical performance of Clareon PanOptix Pro, including findings supporting improved light utilization and enhanced optical quality in the distance-to-intermediate range while preserving performance at established focal points compared to Clareon PanOptix. E-Poster, On Demand

In an exclusive ESCRS 2026 symposium session, Clareon PanOptix Pro will be featured within the theme “Pushing Boundaries in Every Category,” including the session “Raising the Bar in FRoF IOLs: Clareon PanOptix Pro.” Details on the schedule are available at MyAlcon.com.

Clareon PanOptix Pro is commercially available in Europe and most Asian markets, with further rollout subject to local regulatory approvals.

At ESCRS, Alcon will also launch Clareon TruPlus in European markets, a novel enhanced monofocal IOL designed to deliver enhanced intermediate vision, without compromising distance vision. TruPlus is the latest addition to the Clareon Collection, featuring proprietary Opti-Balance Technology which optimizes the curvature of the central optic to direct light to distance vision.

Advancing superior efficiency with Unity Cataract System

Alcon will also spotlight Unity Cataract System (CS) at ESCRS 2026 as a commercially available offering within its next-generation Unity surgical equipment portfolio. Designed to deliver superior efficiency in cataract surgery, Unity CS supports faster nucleus removal and improved OR efficiency.

With cataract procedure volumes increasing and surgical teams facing continued workflow pressures, Alcon says the Unity CS reflects the company's focus on workflow-driven innovation. The system streamlines operating room turnover time and expedites console set-up, designed for rapid vacuum rise with Intelligent IOP1 that precisely controls and maintains the desired IOP setpoint.

• Unity 4D Phaco is a breakthrough ultrasound modality that delivers nucleus removal twice as fast as OZil with 41% less energy delivered to the eye. 
• Intelligent Sentry provides efficient active anterior chamber surge mitigation without losing followability using a proprietary sensor and dual-vent valve technology.
• Unity Thermal Sentry is a first-of-its-kind handpiece that estimates the temperature at the incision site and regulates ultrasound power.

New data at ESCRS 2026 will further characterize Unity VCS|CS performance across phaco efficiency, ultrasound energy delivery, anterior chamber stability and cataract surgery workflow.

• Dr. Ivo Ferreira will present bench data evaluating the novel 4D Phaco ultrasound modality of Unity VCS|CS compared with traditional torsional ultrasound, with results showing improvements in lens removal efficiency alongside reductions in ultrasound energy delivered to the eye. Free Paper, Podium 1 
• Dr. Hisaharu Suzuki will present bench data supporting enhanced anterior chamber stability with Unity VCS during simulated occlusion break events, particularly at lower intraocular pressure (IOP) settings. Free Paper, Podium 1 
• Research by Dr. Lawrence Woodard, presented by Li-Chen Pan, will showcase real-world data evaluating sterile-technician console interactions during cataract surgery setup, supporting the streamlined system design of Unity. e-Poster, On Demand

Alongside Unity CS, Alcon will highlight Unity M, Alcon’s next-generation microscope, designed to deliver precise control to surgeons throughout the surgical procedure. Alcon is also introducing Unity GPS, a new, comprehensive image-guidance technology that seamlessly connects every step of the clinic-to-OR workflow. In combination with SMARTCataract DX for cataract planning, Unity GPS supports execution of the surgical plan in the operating room, helping surgeons optimize placement of IOLs. The technology will be available in Japan and Italy later this month. Alcon rounds out its innovations with SMARTCataract DX, the easier solution for smarter planning and Intelligent Service Solution (ISS) designed to maximize productivity with remote support.

Advancing scientific exchange and surgical education at ESCRS 2026

As part of its Medical Affairs program, Alcon will host peer-to-peer scientific exchange across IOLs, cataract and vitreoretinal surgery and glaucoma care. The program will include the European launch of the Alcon Science Expert Network, a new global initiative driving high-quality scientific engagement among healthcare professionals: 

• “Ray-Tracing-Guided LASIK: Principles and Clinical Outcomes,” led by David Allamby, MBChB, and Dr. med. Ben Asani, FEBO

In addition, Alcon will offer a range of expert-led educational sessions focused on IOL innovation, surgical technologies, and workflow efficiency, designed to help healthcare professionals translate innovation into clinical practice, including:

• “Alcon Eye to Eye – Changing the Game in IOLs: Ready to Go Pro”
• “Unity Surgical Platform – From Vision to Impact in Clinical Practice”
• “Achieving Superior Efficiency in Cataract Surgery” 
• “Unity CS case-based education: Management of a complex cataract case with 4D Phaco and Intelligent Fluidics”

For more information, healthcare professionals are encouraged to visit the Alcon booth at ESCRS (ExCel London C231 & C221), review the complete schedule of Alcon congress activities on MyAlcon.com and follow Alcon, MyAlcon and Alcon Science on LinkedIn for approved congress updates.

Under terms of the agreement, Tarsus paid approximately $450 million upfront, consisting of $270 million in cash and $180 million in Tarsus common stock. The deal also includes milestone payments of up to $350 million upon potential regulatory approval and first commercial sale, and low single-digit tiered descending royalties as a percentage of gildeuretinol net sales. 

With the transaction complete, Tarsus gains ALK-001, an investigational, late-stage small molecule being developed for Stargardt disease. The once-daily oral therapy is designed to reduce the formation and accumulation of toxic vitamin A dimers in the retina while preserving the normal visual cycle.

“Completing the Alkeus acquisition marks an important step forward in our vision to build a leading eye care company,” said Bobby Azamian, MD, PhD, CEO and chairman of Tarsus. “ALK-001 is highly complementary to our core strengths and has the potential to become a foundational medicine for people living with Stargardt disease, a potentially blinding disease with no FDA-approved treatment.”

ALK-001 is currently being evaluated in the global phase 3 NORTHSTAR trial, with topline results anticipated in 2029. According to Tarsus, the investigational therapy has been studied in more than 400 individuals and has demonstrated what the company characterized as a promising tolerability and efficacy profile.

The FDA has granted ALK-001 Breakthrough Therapy, Orphan Drug, Fast Track, and Rare Pediatric Disease designations for Stargardt disease.

• FDA approval of Ciliatech’s IDE allows the company to begin a US feasibility study of the Intercil Uveal Spacer in approximately 30 patients with POAG at 3 clinical sites
• The ab externo implant is designed to support uveoscleral outflow through controlled supraciliary spacing without entering the anterior chamber or creating a subconjunctival bleb
• Ciliatech is evaluating Intercil for patients who may require more intervention than conventional MIGS but may not yet be candidates for filtering surgery

Ciliatech has received FDA approval of its Investigational Device Exemption (IDE) application to begin a US feasibility study of the Intercil Uveal Spacer in patients with primary open-angle glaucoma (POAG).

Ciliatech plans to enroll about 30 patients across 3 US clinical sites. The study will assess the safety and performance of the investigational glaucoma implant, with findings expected to inform subsequent stages of Ciliatech’s US clinical and regulatory development program.

“FDA approval of our IDE application is an important milestone in the US development of Intercil,” Olivier Benoit, CEO of Ciliatech, said in a news release. “It allows us to begin generating US clinical evidence and advance a development program focused on an important unmet need in the glaucoma treatment pathway.”

Intercil is a flat, trapezoidal implant made from hydrophilic acrylic material. Implanted using an ab externo surgical approach, the device is designed to create controlled spacing in the supraciliary space to support uveoscleral outflow. The approach does not enter the anterior chamber or create a subconjunctival bleb.

Ciliatech is positioning the device for what it describes as the “middle segment” of the glaucoma treatment pathway—patients whose disease may require an intervention beyond conventional minimally invasive glaucoma surgery (MIGS) but for whom filtering surgery may not yet be appropriate.

“The middle segment represents an important clinical decision point in the glaucoma treatment pathway,” Mark Packer, MD, chief medical officer, US, at Ciliatech, said in the release. “This feasibility study will provide important US clinical experience with Intercil and help us better understand the potential role of a supraciliary, non-bleb approach for these patients.”

Intercil has previously been studied in Europe through Ciliatech’s SAFARI clinical program. According to the company, data from that program supported its IDE submission and provided clinical experience to help inform the design of the US feasibility study.

Intercil is CE-marked and is in the pre-commercial phase in Europe. In the United States, the device remains investigational and is not approved for commercial sale. The IDE approval permits Ciliatech to use the device in the specified clinical investigation under applicable FDA requirements.

• PretestPro combines 4 ophthalmic pretest assessments into a wearable, guided examination that Heru says can be completed in approximately 90 seconds
• The software performs an 8-point suprathreshold assessment, near cover test, EOM assessment, and quantitative pupillometry, including RAPD and PERRLA status
• Current and future Heru Prime customers will receive PretestPro at no additional charge through a software update

Heru announced the US launch of PretestPro, a new software capability for its Heru Prime wearable platform designed to perform 4 ophthalmic pretest examinations in approximately 90 seconds.

According to the company, PretestPro will be provided at no additional charge to current and future Heru Prime customers through an automatic software update.

The technology uses virtual reality and eye tracking to combine several pretesting assessments into a single guided workflow and generate a consolidated, quantitative report. PretestPro performs an 8-point suprathreshold assessment, near cover test, extraocular motility (EOM) assessment, and quantitative pupillometry, including relative afferent pupillary defect (RAPD) and PERRLA status.

“PretestPro isn’t just a faster test. It is a fundamentally different way to structure the diagnostic workflow,” Mohamed Abou Shousha, MD, PhD, founder and CEO of Heru and professor of clinical ophthalmology at Bascom Palmer Eye Institute at the University of Miami Miller School of Medicine, said in a news release. “Traditional pretesting requires multiple devices and several manual steps. PretestPro consolidates these tests into a single wearable exam that runs about three times faster than traditional testing.”

During testing, patients maintain fixation using Nora, Heru’s patient-guided fixation target. Heru said the underlying virtual reality and eye-tracking modalities have been evaluated in peer-reviewed research.

Practices can also add the platform's visual acuity test, which requires approximately another 30 seconds. According to Heru, the combination allows clinicians to complete about half of their pretesting workflow in approximately 2 minutes.

The company said the approach is intended to reduce reliance on multiple pieces of diagnostic equipment and manual testing while improving workflow consistency. Because Heru Prime is portable, testing can be performed in pretest areas, waiting rooms, or remote settings.

In addition to PretestPro, the Heru Prime platform supports several vision assessments, including suprathreshold visual field testing; full-threshold 24-2, 10-2, and 30-2 visual fields; Esterman visual field testing; visual acuity; Ishihara color vision testing; near and distance cover testing; quantitative pupillometry; and EOM assessment.

• Rayner will introduce RayOne Galaxy Hydrophobic at ESCRS 2026, adding a hydrophobic acrylic option to its Galaxy full-range-of-vision IOL platform
• The new lens combines the Galaxy spiral optic with Rayner's glistening-free hydrophobic material, Amon-Apple 360° Enhanced Square Edge, and a new precision laser-cutting manufacturing process
• Commercial availability of RayOne Galaxy Hydrophobic in CE-marked countries is planned for the fourth quarter of 2026

Rayner announced it will expand its RayOne Galaxy IOL platform with the introduction of RayOne Galaxy Hydrophobic at the European Society of Cataract and Refractive Surgeons (ESCRS) 2026 Congress, taking place September 11-14 in London.

The new IOL combines the spiral optic used in the existing hydrophilic RayOne Galaxy lens with Rayner's hydrophobic acrylic material. According to the company, the addition is intended to give surgeons a choice of lens material while maintaining the visual performance of the Galaxy optical design.

RayOne Galaxy was introduced in 2024 as a full-range-of-vision IOL. Rayner reported that more than 200,000 Galaxy lenses have since been implanted across 75 countries. The lens was designed using a proprietary artificial intelligence engine and employs a spiral optic intended to provide continuous vision from near through distance while minimizing dysphotopsias associated with diffractive trifocal designs.

According to Rayner, RayOne Galaxy Hydrophobic incorporates the same proprietary spiral optic in the company's glistening-free hydrophobic material. The lens also features the Rayner's Amon-Apple 360° Enhanced Square Edge and a new precision laser-cutting manufacturing process intended to minimize posterior capsule opacification (PCO).

Prelaunch evaluations conducted using the Real Artificial Lens Vision (RALV) simulator showed a minimal halo profile and range of vision consistent with the existing hydrophilic Galaxy lens, according to Rayner.

“When we launched Galaxy at ESCRS in 2024, our goal was to redefine what surgeons and patients could expect from premium lenses,” Tim Clover, CEO of Rayner, said in the announcement. “The momentum since then has been incredible. Introducing Galaxy Hydrophobic means that more patients can now benefit from the same quality of vision, whichever material their surgeon uses.”

Galaxy at ESCRS 2026

Rayner plans to demonstrate the expanded Galaxy platform at booth B.200 during ESCRS 2026. Attendees will be able to use the RALV simulator to experience the spiral optic in a simulated night-driving environment.

The company will also hold a lunchtime symposium, “Patients in Focus: Advanced Technology for Premium Eye Care,” on September 13. The program will include 12-month multicenter outcomes with the Galaxy IOL as well as comparative clinical data against another full-range-of-vision IOL.

Filomena Ribeiro, MD, PhD, will moderate the symposium, with Victor Caparas, MD; Başak Bostancı, MD; Josefina Botta, MD; and Kieren Darcy participating. The program will also address intraoperative approaches to endothelial cell protection using the Sophi phacoemulsification system.

Rayner said additional activities at its booth will include Sophi wet labs and expert presentations focused on operating-room workflow and clinical practice.

RayOne Galaxy Hydrophobic is expected to become commercially available in CE-marked countries beginning in the fourth quarter of 2026.

• Ohio Gov. Mike DeWine has been named the 2026 recipient of the Bonnie Strickland Champion for Children’s Vision Award for his leadership in developing the OhioSEE program
• During its initial year, OhioSEE provided comprehensive eye examinations to 1,900 children and free eyeglasses to 1,200 children, with services currently reaching schools in 15 counties

The National Center for Children’s Vision and Eye Health at Prevent Blindness (NCCVEH) has named Ohio Gov. Mike DeWine the recipient of the 12th annual Bonnie Strickland Champion for Children’s Vision Award, recognizing his leadership in establishing the Ohio Student Eye Exam (OhioSEE) program and expanding access to pediatric eye care across the state.

The award will be formally presented during a virtual NCCVEH event on September 11, 2026, at 10 am ET.

Established in 2014, the Bonnie Strickland Champion for Children’s Vision Award recognizes individuals or groups that have made significant contributions to public health approaches for children’s vision and eye health at the state or national level. The award honors Bonnie Strickland and her work to establish a comprehensive system for children’s vision in the United States.

Gov. DeWine was selected in recognition of his efforts to develop a sustainable system of eye care for children in Ohio, including support for a $25 million allocation to expand the initiative.

In 2024, Gov. DeWine led the formation of the Children’s Vision Strike Force, an initiative designed to address gaps in follow-up care for students who did not pass certified vision screenings. The effort focused on connecting those children with comprehensive eye examinations and eyeglasses when needed.

Gov. DeWine subsequently developed OhioSEE to strengthen the continuum of vision and eye health care for children throughout the state. During the program’s initial year, 1,900 children received comprehensive eye examinations and 1,200 received free eyeglasses, according to Prevent Blindness. OhioSEE currently supports mobile vision vans and temporary clinics that bring comprehensive eye examinations directly to schools in 15 counties.

Gov. DeWine has allocated $25 million through the Rural Health Transformation Fund to expand OhioSEE statewide and add pathways for delivering eye examinations to children in need.

"When my wife, Fran, and I learned that only 1 in 4 kids actually receive comprehensive eye exams and follow up vision care that they need, we knew we needed to help find a solution quickly," Gov. DeWine said. "OhioSEE brings vision care directly to the child in their school, so no child is missed."

Key Takeaways

• Orbis' first Flying Eye Hospital simulation project in Macau will train 70 ophthalmologists and nurses from eight partner hospitals across China
• Training will cover cataract, glaucoma, strabismus, medical retina, and nursing, with Cybersight providing continuing education and mentorship beyond the on-site program.
• The project marks 20 years of Orbis Macau, during which the Macau community has raised more than $33 million to support Orbis' eye care programs in China and worldwide

Orbis International is marking two decades of partnership with the Macau community by bringing its Flying Eye Hospital to the city for its first simulation-based training project in Macau.

The initiative will provide advanced training and mentorship to 70 ophthalmologists and nurses from eight Orbis partner hospitals across China. Participants will train aboard the Flying Eye Hospital and at Kiang Wu Nursing College of Macau, with the clinicians collectively serving more than 245,000 patients in China each year.

Training will include simulation-based instruction in cataract, glaucoma, strabismus, medical retina, and ophthalmic nursing. Orbis said the program is designed not only to strengthen participants' clinical skills but also to enable them to share their knowledge with colleagues and future generations of eye care professionals.

The project comes 20 years after Orbis Macau was established in 2006. Since then, the Macau community has raised more than $33 million to support the nonprofit's work in China and internationally. Orbis Macau has worked with donors, companies, schools, foundations, and volunteers to support clinician training, stronger eye care systems, and greater access to quality eye care.

"For twenty years, the people of Macau have stood beside Orbis as partners in our mission," said Isabel da Silva, director of development at Orbis Macau. "The real story of this visit is not just the aircraft. It's the thousands of individuals, companies, schools, and volunteers of Macau who have supported Orbis over the last two decades."

Cybersight, Orbis' telemedicine and e-learning platform, will complement the in-person training. Participants can use the platform to prepare before the program, consult with international experts, access continuing education, and continue developing their skills after the Flying Eye Hospital leaves Macau.

"By bringing eye care teams from across China together for advanced simulation training and connecting them to ongoing mentorship through Cybersight, we are investing not only in individual clinicians, but in stronger eye care systems," said Orbis President and CEO Kathleen Sherwin.

Alcon, which has supported Orbis for more than 45 years, is providing financial support for the Flying Eye Hospital through the Alcon Foundation. The company also provides ophthalmic equipment, surgical products, and supplies through Alcon Cares.

Omega, a supporter of Flying Eye Hospital projects since 2011, is also participating in the Macau initiative. The company works with its brand ambassadors to raise awareness of Orbis' mission and provides teddy bears to pediatric patients treated aboard the aircraft.

The Macau project is part of Orbis' 2026 Flying Eye Hospital global program. Other organizations supporting the initiative include Macau International Airport Co. Ltd., Menzies Aviation Macau, TAG Aviation Asia (Macau) Ltd., Min Da Construction & Engineering Co. Ltd., Sands China Ltd., MGM, Kiang Wu Nursing College of Macau, CSI Group Macau, Macau Coca-Cola Beverage Co. Ltd., FedEx, Woodward Inc., AirAsia, Embraer, and GE Aerospace.

• Nidek has launched the RSD-1 Duo OCT/Fundus Camera, AFC-1 Non-mydriatic Auto Fundus Camera,and EyeLink Eye Care Data Management Platform
• The RSD-1 Duo combines expanded OCT imaging and fundus photography with PC-free analysis, reference database capabilities and optional OCT angiography
• EyeLink centralizes imaging data and, with the optional Retina Viewer, provides advanced OCT and OCT angiography analysis, including deep learning-based segmentation and longitudinal image comparison

Nidek announced the launch of 3 ophthalmic technologies designed to streamline imaging, screening, analysis and data management: the RSD-1 Duo OCT/Fundus Camera, AFC-1 Non-mydriatic Auto Fundus Camera, and EyeLink Eye Care Data Management Platform.

The company plans to showcase the new products at the European Society of Cataract and Refractive Surgeons (ESCRS) 2026 meeting, scheduled for September 11-14 in London.

The RSD-1 Duo combines optical coherence tomography (OCT) and fundus photography, while the AFC-1 provides nonmydriatic fundus imaging. According to Nidek, both systems incorporate automated operation intended to support consistent image acquisition while reducing operator workload.

For color fundus imaging, the RSD-1 Duo and AFC-1 use slit-scan technology designed to produce high-contrast, high-definition images while reducing artifacts and shadows. The systems provide 50° imaging in pupils as small as 2.0 mm and can automatically combine as many as 7 images to create a panoramic composite. Fundus autofluorescence imaging is also available with the FAF model of the RSD-1 Duo.

The RSD-1 Duo expands OCT B-scan imaging to as much as 16.5 mm in width and 3.0 mm in depth. According to the company, the larger imaging area can capture anatomy extending from the optic nerve head to the temporal vascular arcade and accommodate the oblate retinal shape associated with myopic eyes.

The system also incorporates B-scan denoising technology, and optional OCT angiography uses an imaging algorithm designed to suppress artifacts and improve visualization of vascular detail.

Nidek said the RSD-1 Duo can perform basic analysis and generate reports without requiring an external PC. Its retina map captures the optic disc and macula and supports reference database analysis of both the retinal nerve fiber layer and ganglion cell complex from a single OCT image.

For glaucoma assessment in eyes with axial myopia, a long axial length reference database provides analysis incorporating axial-length compensation. The device automatically selects between the regular and long axial length reference databases using an axial-length value derived from OCT image acquisition. The company noted that this calculated value differs from an actual measured axial length.

The standard reference database was developed using data from a sample of Caucasian and Asian patients, whereas the long axial length database was developed from a sample of Asian patients.

Both the RSD-1 Duo and AFC-1 offer PC-free operation and connectivity options that include direct DICOM connectivity and integration with Nidek's new EyeLink platform.

EyeLink is designed to centralize patient imaging data on a server, allowing images acquired with the RSD-1 Duo and AFC-1 to be automatically transferred to the platform and accessed from multiple PCs throughout a clinical practice. An optional Retina Viewer application extends the platform's OCT and OCT angiography analysis capabilities. Its deep learning-based segmentation identifies retinal layer boundaries on B-scan images, which serves as the basis for Nidek's Structural Normality Map. The map is designed to identify and highlight structural abnormalities, including subtle retinal changes, to assist clinicians with image interpretation.

Optional denoising licenses are available for B-scan and OCT angiography images. The viewer also provides quantitative OCT angiography metrics intended to assist with assessment of disease progression and treatment response. For longitudinal evaluation, automatic image registration enables clinicians to compare changes at the same retinal location across examinations, including studies performed with different scan sizes or orientations. Additional tools include anterior chamber angle analysis, pachymetry mapping and epithelial mapping for anterior segment assessment.

"We believe that the RSD-1 Duo and AFC-1, featuring effortless image capture, high-quality imaging, PC-free operation and analysis, and broad connectivity, streamline clinical workflows and support faster, more confident decision-making," Motoki Ozawa, president and CEO of Nidek, said in the company's announcement.

Mr. Ozawa added that EyeLink provides clinicians with a dedicated viewer and advanced analysis capabilities, with Nidek planning to continue expanding the platform.

The company said it will demonstrate the RSD-1 Duo, AFC-1 and EyeLink at booth D.300 during ESCRS 2026.

• Alcon has begun the commercial launch of the Unity M surgical microscope in select markets, including the United States and Japan, with Europe to follow
• The base system combines an expanded red reflex zone, color-tunable illumination, and an ophthalmology-optimized depth of field to support visualization during surgery
• Unity M uses a modular architecture designed for anterior and posterior segment surgery and is intended to integrate with Alcon's broader Unity ecosystem

Alcon announced the initial commercial launch of the Unity M premium surgical microscope in select markets, including the United States and Japan, with a European launch to follow. The company will feature the new microscope at the European Society of Cataract and Refractive Surgeons (ESCRS) Congress September 11-15 in London.

Unity M is the third addition to Alcon’s Unity surgical platform, following Unity VCS and Unity CS. The microscope combines optical and illumination technologies with a modular architecture designed to allow ophthalmic practices to configure the system according to their clinical needs and add upgrades over time.

“The idea behind the Unity platform is to develop clinic-based and operating room equipment solutions with a seamless user experience that improve surgical workflows,” Ian Bell, senior vice president and chief operating officer of Alcon, said in a statement. “By partnering closely with eye care professionals to understand their most significant unmet needs, we developed Unity M to provide a flexible, future-ready visualization platform that gives surgeons precise control and personalization in the operating room.”

According to Alcon, the Unity M base model incorporates 3 principal visualization features: an expanded red reflex zone, color-tunable illumination, and a depth of field optimized for ophthalmic surgery.

Alcon said the microscope provides a red reflex zone up to 6 times larger than that of the Zeiss Artevo. The company said the red reflex is designed to remain stable as the eye moves, helping surgeons maintain visualization across different pupil sizes and microscope positions.

The microscope also incorporates what Alcon describes as the first color-tunable illumination system for a surgical microscope. The technology allows illumination to be adjusted to enhance contrast and visualization of tissue details compared with traditional illumination systems.

Unity M's depth of field is optimized for ophthalmic procedures and designed to maintain visualization of ocular structures as the eye shifts during surgery.

“Visualization is fundamental to every procedure I perform because it directly impacts the level of control I have throughout surgery,” Eric Rosenberg, MD, of SightMD in Long Island, New York, said in the announcement. “During critical moments of a case, having a stable view helps me operate with confidence and precision. The combination of a stable red reflex, advanced illumination and enhanced depth of field provides the visualization I need to maintain control from one stage of surgery to the next, while the platform's flexibility allows me to tailor the system to my specific preferences.”

Alcon designed Unity M as a modular system that can be configured for both anterior and posterior segment surgeons. Purpose-built options can be selected according to a practice's needs, with additional modular upgrades incorporated as those needs change. The microscope is also designed for current and future integration with Alcon's broader portfolio of equipment, digital technologies, and services.

The company said additional Unity M modules are planned as it continues to develop the Unity ecosystem.

Unity M has received regulatory approvals in the United States, Canada, Japan, India, and Europe, including CE marking. Alcon said inventory will begin shipping in September.

The microscope will be displayed at Alcon's booth C231 at ExCeL London during ESCRS. The company will also discuss the platform during its “Unity Surgical Platform – From Vision to Impact in Clinical Practice” symposium on September 13 at 9:30 am.

• Bausch + Lomb will present a broad portfolio of research at ESCRS 2026, including data on the LuxLife, enVista Aspire, and enVista Envy IOLs, along with refractive surgery and ocular surface technologies
• Multiple studies will evaluate excimer laser trabeculostomy and the Elios procedure, with outcomes ranging from short-term real-world findings to 5-year data on IOP reduction, visual fields, and retinal nerve fiber layer thickness

Bausch + Lomb will present new scientific data evaluating its IOL, glaucoma, refractive surgery, and ocular surface technologies during the European Society of Cataract and Refractive Surgeons (ESCRS) annual congress, scheduled for September 11-15, 2026, in London.

The company's scientific program will include studies of the LuxLife, enVista Aspire, and enVista Envy IOLs, as well as the Elios procedure for glaucoma. Additional presentations will examine refractive surgery and dry eye technologies. Register here for demonstrations.

Bausch + Lomb will also feature technologies from across its surgical and eye care portfolios at booth C.142, including enVista Envy, LuxLife, Elios, the Teneo Excimer Laser Platform, and Artelac Complete.

Bausch + Lomb is a sponsor of Glaucoma Day, the Excimer Laser Celebration, and iNovation Day, where Chief Executive Officer Brent Saunders will join the “MedTech Leadership Panel,” offering perspectives for the next 5 years, and Executive Vice President of Research and Development and Chief Medical Officer Yehia Hashad will join another group of industry leaders to discuss “Interventional Glaucoma in the Cataract Practice.” Saunders also will participate in the Ophthalmology Futures Forum leaders panel discussion.

Following is a complete list of Bausch + Lomb events and scientific presentations.

Saturday, September 12, 2026
Satellite Symposium - Redefining the Surgical Experience: Bausch + Lomb’s Fully Integrated Innovative Surgical Suite

• 13:00-14:00, George V Room 1
• Speakers: Dr. Robert E. Ang, Dr. Alain Saad, Dr. José Manual Larrosa, Dr. Adam Muzychuk, Dr. Vittorio De Grande
• Join a panel of experts as they discuss their experience with Bausch + Lomb technologies including the SeeLuma™ iOCT and enVista Envy and share a complete case involving the ELIOS procedure for the treatment of glaucoma and the LuxSmart™ IOL.

Sunday, September 13, 2026
IME Symposium: Simultaneous Vision IOL IME Forum: Achieving Functional Vision – What Is the Right Solution for Today’s Patients?

• 10:15-11:30, Victoria Room 5/6
• During the IME symposium, Dr. Belén Alfonso Bartolozzi will present a case study with the enVista Envy IOL.

AI Digital Summit

• 10:15-12:00, Victoria Room 3
• During this session, Jay Charnalia, Senior Director, Commercial Ops Surgical & Head of Customer Service Europe, Bausch + Lomb, will present on how the company is providing AI applications to improve doctor practices for today and the immediate future.

Lift Off in London

• 18:00-22:30. Please register here and receive details about the event and location.
• During this dynamic and interactive evening, discover the latest Bausch + Lomb Surgical Suite advances while enjoying refreshments and networking with your peers and the Bausch + Lomb team.

Podium Presentations

• “Visual And Refractive Outcomes Of An Enhanced Monofocal Intraocular Lens In A Prospective, Real World Spanish Multicentre Study.” Castro F.
• “Effectiveness Of Excimer Laser Trabeculostomy Treatment In Patients With Glaucoma Over 18 Months Of Follow-Up.” De Grande V.
• “Clinical Outcomes And Patient Satisfaction With A Full Range Of Vision Intraocular Lens: A Single-Centre Prospective Study.” Gaeckle H.
• “Pre-clinical Evaluation of Glare Phenomena in Presbyopia-Correcting Intraocular Lenses.” Gu S.
• “Managing Dry Eye Before and After Refractive Surgery.” Labetoulle M.
• “Clinical Performance of Enhanced Monofocal Intraocular Lenses In Real World Multicenter Study.” McCabe C.
• “Effectiveness Of The Excimer Laser Trabeculostomy Procedure In Patients With Primary Open-Angle Glaucoma Undergoing Cataract Surgery.” McCabe C.
• “Visual And Refractive Outcomes From A Multicentric, Prospective Study In Patients Bilaterally Implanted With An Enhanced Monofocal Intraocular Lens.” McCabe C.
• “A comparison between Mini-Monovision and Bilateral Emmetropia: An assessment of clinical outcomes with an enhanced monofocal intraocular lens.” Micheletti M.
• “Changes In Visual Field And Peripapillary Retinal Nerve Fibre Layer Thickness After Combined Excimer Laser Trabeculostomy And Phacoemulsification: Five Years of Follow-Up.” Moreno-Valladares A.
• “Real World Data Of IOP Reduction With Combined Excimer Laser Trabeculostomy And Phacoemulsification At Five Years Of Follow-Up.” Moreno-Valladares A.
• “Impact Of Residual Refractive Error On Visual Acuity In Eyes Implanted With A Full Visual Range Intraocular Lens.” Muzychuk A.
• “Assessment Of The Patient-Reported Outcomes Following Bilateral Implantation Of An Enhanced Monofocal Intraocular Lens In Cataract Patients.” Sadri E.
• “Safety Outcomes Of Excimer Laser Trabeculostomy Performed In Conjunction With Cataract Surgery In Primary Open-Angle Glaucoma Patients.” Singh P.
• “Acuity, Wavefront, Stereo And Satisfaction Outcomes Of Supracor Transepithelial Phototherapeutic Keratectomy (TransPRK) In Myopic Presbyopes.” Tagal JM.

Posters

• “Clinical outcomes and eye care practitioner satisfaction with Artelac dry eye lubricating drops in patients with dry eye disease: a retrospective real-world evidence study.” Altroudi W.
• “Long-Term Follow-Up In A Clinical Study Of Transepithelial Photorefractive Keratectomy Versus Conventional Photorefractive Keratectomy.” Ang R.
• “Clinical outcomes of an enhanced monofocal intraocular lens in patients with cataract: A real-world study.” Harasymowycz P.
• “Visual And Safety Outcomes Of Cataract Surgery With A Full Visual Range Intraocular Lens: Real World Evidence Study.” Katz J.
• “Evaluation Of An Ectoine-Containing Ophthalmic Solution In The Treatment Of Dry Eye Disease.” Labetoulle M. et al.
• “Visual Performance Of A Full Visual Range, Non-Toric Intraocular Lens Following Cataract Surgery In Routine Clinical Practice.” Muzychuk A.
• “Real-World Excimer Laser Trabeculostomy Combined With Cataract Surgery In Patients With Primary Open Angle Glaucoma Or Ocular Hypertension: Safety And Effectiveness At 1 Month.” Nijm L.
• “Performance Of An Enhanced Monofocal IOL: Outcomes Of A Non-Interventional, Prospective, Multicenter Clinical Study.” Parekh J.
• “Visual And Refractive Outcomes Of A Small Aperture Intraocular Lens In Keratoconic Eyes After Cataract Surgery.” Schartmüller D.
• “Clinical Outcomes Of Enhanced Monofocal Non-Toric And Toric Intraocular Lenses In Patients Following Cataract Extraction: A Retrospective Case Series.” Stephenson D.
• “Clinical Performance And Visual Outcomes With A Full Visual Range Toric Intraocular Lens.” Stephenson D.
• “Clinical Performance And Visual Outcomes Of A Novel Monofocal Plus Intraocular Lens: A Single-Center Experience with The Envista Aspire IOL.” Wowra B.
• “Early Outcomes Of A Partial Range Of Field Monofocal Intraocular Lens Following Cataract Surgery: A Case Series.” Yau K.
• “Interim Analysis Of A Multicentre, Retrospective, Real-World Assessment Of the Performance And Safety Of A New Enhanced Intraocular Lens In Patients Undergoing Cataract Surgery.” Leydolt C. et al.
• “Retrospective real-world evidence study: utilisation patterns and clinical outcomes with two types of lubricating eye drops in patients with dry eye disease.” Wozniak P.

*Not available in the United States.

Other research will evaluate full-range-of-vision IOLs, including the effect of residual refractive error on visual acuity and clinical outcomes and patient satisfaction following implantation.

Poster presentations will further examine enhanced monofocal, full-range-of-vision, toric, and other IOL designs. Among the studies are investigations of enVista Aspire, including clinical performance and visual outcomes with the monofocal-plus IOL, as well as real-world analyses of enhanced monofocal lenses.

The company will also participate in an independent medical education symposium September 13 addressing simultaneous-vision IOLs and functional vision. During the program, Belén Alfonso Bartolozzi, MD, is scheduled to present a case involving the enVista Envy IOL.

Elios glaucoma data include follow-up to 5 years

Multiple presentations will focus on excimer laser trabeculostomy and the Elios procedure for lowering IOP in patients with glaucoma.

Podium research includes an evaluation of the effectiveness of excimer laser trabeculostomy through 18 months of follow-up and another study examining the procedure in patients with primary open-angle glaucoma undergoing cataract surgery.

Longer-term findings will also be presented. Two studies will report 5-year outcomes following combined excimer laser trabeculostomy and phacoemulsification, including changes in visual field and peripapillary retinal nerve fiber layer thickness and real-world IOP reduction.

Additional research will assess safety when excimer laser trabeculostomy is performed with cataract surgery in patients with primary open-angle glaucoma.

A poster will report 1-month real-world safety and effectiveness outcomes for excimer laser trabeculostomy combined with cataract surgery in patients with primary open-angle glaucoma or ocular hypertension.

The company will further highlight the technology during a September 12 satellite symposium on its integrated surgical portfolio. The program will include discussion of the Elios procedure alongside technologies including SeeLuma intraoperative OCT and the LuxSmart and enVista Envy IOLs.

Refractive surgery and dry eye research planned

Bausch + Lomb's ESCRS program will also include refractive surgery research. One podium presentation will examine acuity, wavefront, stereopsis, and patient satisfaction outcomes following Supracor transepithelial phototherapeutic keratectomy in patients with myopic presbyopia.

A separate poster will report long-term findings from a study comparing transepithelial photorefractive keratectomy with conventional photorefractive keratectomy.

Ocular surface research will include a presentation addressing dry eye management before and after refractive surgery. Posters will examine clinical outcomes and practitioner satisfaction with Artelac lubricating eye drops, an ectoine-containing ophthalmic solution for dry eye disease, and real-world utilization and outcomes associated with 2 types of lubricating drops.

Beyond its scientific program, Bausch + Lomb will sponsor several events during ESCRS, including Glaucoma Day, the Excimer Laser Celebration, and iNovation Day. CEO Brent Saunders is scheduled to participate in a medical technology leadership panel as well as the Ophthalmology Futures Forum leaders panel.

Yehia Hashad, MD, executive vice president of research and development and chief medical officer at Bausch + Lomb, will participate in a discussion focused on interventional glaucoma in cataract practices.

The company will also host educational programs covering its surgical technologies and participate in an artificial intelligence-focused session addressing applications intended to support ophthalmic practices.

• Zeiss will showcase cataract technologies including the AT Lucia toric 721P IOL, a cataract configuration of the Dorc Eva Nexus system, and the cloud-based Zeiss Surgery Planner
• A VisuMax 800 software update will add arcuate incision capabilities and CentraLign Auto centration in CE-marked markets
• The company will preview retinal imaging and virtual reality-based perimetry technologies intended to expand its screening and diagnostic portfolio

Zeiss will showcase additions to its cataract, corneal refractive, and retinal portfolios during the European Society of Cataract and Refractive Surgeons (ESCRS) Congress, scheduled for September 11-14, 2026, in London.

The company said its presentations will span IOLs, cataract surgical systems and planning, laser vision correction, and screening and diagnostic technologies.

Cataract workflow additions

Among the cataract technologies on display will be the Zeiss AT Lucia toric 721P IOL, a hydrophobic monofocal toric lens designed to address cataracts and astigmatism. According to the company, the IOL incorporates its patented Zeiss Optic nonconstant asphericity profile.

Zeiss plans to hold an event September 12 from 10:00–11:00 AM BST at Booth C.100 featuring surgeons who were among the first to implant the lens worldwide. The company will also recognize several surgeons with its Pioneer Award for early implantations.

The company will also showcase the Dorc Eva Nexus ophthalmic surgical system in a cataract-only configuration. The system includes a cataract grade selection feature with as many as 4 programmable presets, allowing surgeons to select phacoemulsification, aspiration, and irrigation settings for individual surgical steps and cataract grades. Settings can be activated using the footswitch or screen.

Another focus will be the newly available Zeiss Surgery Planner, a cloud-based digital planning platform for cataract surgery. Used with Zeiss Data Analyzer, the platform is designed to connect a practice's electronic medical record system with the operating room while supporting IOL calculations, collaboration among clinical staff, and data analysis.

Zeiss said the platform builds on its experience with Veracity Surgery Planner, which has been used to plan more than 3 million cases in the United States. Zeiss Surgery Planner is expected to become available in fall 2026 in select markets, including Australia, Brazil, Germany, and Spain.

“With Zeiss Surgery Planner, we are advancing cataract surgery planning from manual coordination to a connected, cloud-based and data-driven workflow, helping practices reduce complexity while giving surgeons more time to focus on patient care,” Frank Seitzinger, head of Business Sector Surgery Anterior Segment at Zeiss Medical Technology, said in the announcement.

To address the rapid development of advanced IOL technologies, Zeiss will host a group of industry-leading surgeons on September 13, from 3:00 – 4:00 PM BST to discuss the use of different IOLs based on their clinical and personal experiences. Participating surgeons include Dr. Javier Coloma from Clínica Baviera (Spain), Prof. Haike Guo from Shanghai Heping Eye Hospital (China), Dr. Mfazo Hove from Blue Fin Vision (UK), Dr. Jiwon Jeong from Fatima Eye Clinic (South Korea), Dr. James Myerscough from Southend University Hospital NHS Foundation Trust (UK), and Dr. Jascha Wendelstein from The Institute for Refractive and Ophthalmic Surgery (Switzerland).

Zeiss will also host its Cataract Surgery Symposium on September 13, from 1:00 – 2:00 PM BST. The event will highlight “Converting astigmatism complexity into predictable outcomes with digital cataract surgery” and feature key insights from some of the industry’s leading surgeons.

Corneal refractive workflow updates

For refractive surgery, Zeiss will present a software update for the VisuMax 800 femtosecond laser. In CE-marked markets, the update includes a new option for arcuate incisions as well as CentraLign Auto centration.

According to Zeiss, the arcuate incision capability expands the platform's laser vision correction applications. CentraLign Auto is an assistant system that automates lateral movement of the device to support eye centration before docking and facilitate the docking process.

The company also plans to showcase consultation tools and educational resources intended to help refractive practices identify and counsel candidates for laser vision correction.

Zeiss will celebrate its partnership with leading refractive clinics around the world with a special event on September 13, from 10:00–11:00 AM BST. Hear from leading experts, including Dr. Dan Reinstein from London Vision Clinic (UK), Dr. Chao-Kai Chang from Nobel Eye Institute in Taipei (Taiwan), Dr. Fengju Zhang from Beijing Tongren Hospital (China), and Dr. Miriam Meddour from Smile Eyes Hamburg (Germany), about why they’ve chosen ZEISS LVC solutions, including Zeiss SMILE pro and Zeiss PRESBYOND, and how clinics use these solutions for business growth.

Additionally, Zeiss will host its Corneal Refractive Surgery Symposium at ESCRS on September 12 from 1:00–2:00 PM BST. The event will offer key business growth insights from some of the world’s leading refractive surgeons.

Screening and diagnostic technologies previewed

Zeiss will also preview technologies under development for its screening and diagnostics portfolio.

One is a retinal diagnostic offering intended to complement the Cirrus OCT portfolio and support multimodal retinal imaging. The company said the technology is being developed to simplify imaging workflows and facilitate routine retinal imaging across clinical settings.

A second offering involves virtual reality-based perimetry designed to complement Humphrey Field Analyzer visual field testing. According to Zeiss, the technology is intended to support detection of visual field defects as part of comprehensive glaucoma diagnostics.

The company plans to reveal additional details about the future screening and diagnostic offerings during an event September 11.

Zeiss will exhibit at booth C.100 in the South Event Hall during ESCRS 2026.

• Wills Eye Hospital named Sunir Garg, MD, chief of its Retina Service, and Christina McGowan, MD, chief of its Cataract and Primary Eye Care Service, effective July 1, 2026
• Dr. Garg succeeds Carl Regillo, MD, and plans to focus on expanding retina services, research, education, and industry partnerships
• Dr. McGowan succeeds Doug Wisner, MD, with priorities that include resident education, cross-department collaboration, innovation, and renovation of the CPEC space

Wills Eye Hospital announced leadership changes within its Retina Service and Cataract and Primary Eye Care (CPEC) Service, naming Sunir Garg, MD, chief of Retina, and Christina McGowan, MD, chief of CPEC.

Dr. Garg, previously co-director of Retina Research, succeeds Carl Regillo, MD, as chief of the Wills Eye Retina Service. Dr. McGowan moves into the CPEC leadership position after serving as co-director and medical director of the department, succeeding Doug Wisner, MD.

Both physicians assumed their new roles July 1, 2026.

“We look forward to wonderful new eras for Retina and CPEC, building on the tremendous legacy of both services’ history, and the remarkable leadership of outgoing chiefs, Drs. Carl Regillo and Doug Wisner,” Julia A. Haller, MD, chief executive officer and ophthalmologist-in-chief of Wills Eye Hospital, said in the announcement. “Under the expert stewardship of Dr. Garg and Dr. McGowan, I have no doubt the Retina and CPEC services will continue to grow and thrive as the teams work tirelessly to protect and preserve the vision of our patients.

Wills Eye operates its Retina Service in partnership with Mid-Atlantic Retina. According to the institution, the service has 30 physicians, the largest staff in the department’s 65-year history. In 2025, the retina team performed more than 4,000 surgical cases and published more than 100 peer-reviewed papers based on original research conducted at Wills Eye. Its physicians have also held leadership roles in multicenter clinical trials.

Over the past 2 decades, the Retina Service has participated in advances involving injectable biologic therapies, ophthalmic imaging, and less invasive vitrectomy techniques, according to Wills Eye. The service also maintains a significant role in training retina specialists.

Dr. Garg has held several leadership positions in ophthalmology, including president of the Greater Philadelphia Ophthalmology Society, chair of the Wills Eye Annual Conference, and chair of the American Academy of Ophthalmology Annual Meeting Retina Committee. He has also served on the Academy’s Ethics Committee and as a clinical spokesperson.

His honors include 3 American Academy of Ophthalmology Secretariat Awards, the American Society of Retina Specialists Presidential Award, and the inaugural Women in Retina Champion Award. Dr. Garg serves on the executive committee of the American Society of Retina Specialists and is slated to become the Academy’s secretary for online education in 2027.

He said his priorities include expanding clinical services, supporting surgeons and educators, advancing research, and strengthening industry partnerships aimed at developing new treatments for retinal disease.

The CPEC Service provides comprehensive care for conditions affecting vision and ocular health, including examinations, evaluations, and surgical treatment. The department also serves as an entry point for many Wills Eye patients before referral to subspecialty services. During the most recent calendar year cited by Wills Eye, CPEC treated more than 16,000 patients and its staff performed more than 2,600 surgeries.

Dr. McGowan joined Wills Eye in 2015 and has served in the CPEC department throughout her tenure. Her teaching honors include the institution’s Residency Advocacy Award and Golden Apple Teaching Award. She has also been recognized as a Top Doctor by Castle Connolly and Philadelphia Magazine.

According to Wills Eye, Dr. McGowan spends her clinical and surgical time working alongside trainees, integrating resident education into patient care.

Among her priorities, Dr. McGowan cited strengthening collaboration between departments and working with Wills Eye administration toward a renovation of the CPEC space.

• Interim phase 1b findings showed ophthalmic responses in 3 of 5 evaluable Chinese participants, with individual patients demonstrating improvements in visual acuity, color vision, and microperimetry
• DF-003 treatment was associated with improvements in systemic ROSAH manifestations and reductions in multiple inflammatory biomarkers, with some effects partially reversing after treatment ended
• Drug Farm plans to advance the oral ALPK1 inhibitor into a Phase 3 pivotal trial

Drug Farm reported positive interim findings from an international phase 1b study of DF-003, an investigational oral ALPK1 inhibitor, showing improvements in visual function and several systemic manifestations among adults with ROSAH syndrome.

The findings were presented by Ruifang Sui, MD, PhD, at the Asia-Pacific Vitreo-retina Society 2026 Congress in Gold Coast, Australia. According to the company, the results support continued clinical development of DF-003, including a planned phase 3 pivotal trial.

ROSAH syndrome is a rare genetic autoinflammatory disorder caused by activating mutations in ALPK1. The disease is characterized by progressive retinal degeneration as well as systemic inflammatory manifestations.

The open-label phase 1b study enrolled 11 adults with genetically confirmed ROSAH syndrome at 3 clinical sites in China, Australia, and the United States. Participants received DF-003 at 140 mg orally once daily for 3 days, followed by 45 mg once daily through Day 28. At the time of the presentation, 9 participants had completed follow-up through Day 78, while 2 remained in follow-up.

The APVRS presentation included detailed findings from 5 participants treated at Peking Union Medical College Hospital in China. Investigators reported improvements across ophthalmic function, anhidrosis, headache, arthralgia, and quality of life that were consistent with observations among participants enrolled in the United States and Australia.

For the presented analysis, an ophthalmic response was defined as an improvement of at least 2 lines in best-corrected visual acuity (BCVA) or low-luminance BCVA in at least 1 eye, or an improvement of at least 5 dB on microperimetry at 5 or more loci that was consistent with the direction of the BCVA change.

Three of the 5 Chinese participants met these response criteria. The other 2 had advanced visual impairment that limited assessment using the prespecified measures, according to Drug Farm.

One 20-year-old participant experienced an 11-letter improvement in BCVA. Color vision improved from 20 of 25 Ishihara plates at baseline to 25 of 25 by Day 15, with the improvement maintained through Day 78. The same participant experienced improvement in anhidrosis, with sweating returning beginning on Day 15. Objective testing demonstrated increased sweat production, and the patient reported improved heat tolerance. Weekly fever was absent during treatment but returned following treatment cessation. High-sensitivity C-reactive protein (hsCRP) in this participant decreased from 100 mg/L on Day 2 to 1.64 mg/L on Day 29. Improvements in mobility, fatigue, sleep quality, and arthralgia were also reported.

A second participant, who had advanced ocular disease, severe visual impairment, and a complicated cataract, also demonstrated an 11-letter improvement in visual acuity. Microperimetry showed improvements of at least 5 dB at 17 of 68 matched loci in the right eye and 15 of 68 matched loci in the left eye. These included spatially coherent clusters of at least 5 contiguous loci in each eye, according to Drug Farm. Intermittent fever was absent during treatment in this participant, while hsCRP decreased from 19.8 mg/L at baseline to 0.63 mg/L by Day 15.

Across the 5 Chinese participants, improvements in anhidrosis were observed through both objective sweat testing and patient-reported assessments. Improvements in headache burden, arthralgia, and quality of life were also reported among evaluable participants.

“These interim findings are encouraging because improvements were observed across both ocular and systemic manifestations of ROSAH syndrome,” Dr. Sui, chief physician and professor at Peking Union Medical College Hospital, said in a company announcement. “In particular, the changes observed in visual function together with improvements in sweating, systemic symptoms, and inflammatory biomarkers support continued evaluation of ALPK1 inhibition as a potential therapeutic approach for patients with ROSAH syndrome.”

DF-003 was reported to be well tolerated in the interim analysis. No serious adverse events were observed, and no adverse events occurred during the 28-day treatment period. Drug Farm said all recorded adverse events occurred after treatment ended and were primarily associated with the reemergence of ROSAH symptoms.

No clinically meaningful treatment-emergent laboratory abnormalities were identified. Pharmacokinetic findings were generally consistent among participants enrolled in China and elsewhere and supported once-daily oral administration, according to the company.

Drug Farm plans to advance DF-003 into a phase 3 pivotal trial in patients with ROSAH syndrome. Longer treatment and evaluation in a larger patient population will be needed to determine the durability and magnitude of the ophthalmic and systemic effects suggested by the small, open-label phase 1b study.

• Real-world data from 141 eyes showed that enVista Aspire and enVista Aspire toric IOLs provided good distance visual acuity alongside functional intermediate vision after cataract surgery
• All patients in both study groups achieved binocular uncorrected intermediate visual acuity of 20/32 or better, and no serious adverse events were reported

Bausch + Lomb announced the publication of new real-world research evaluating visual and refractive outcomes with its enVista Aspire and enVista Aspire toric IOLs in patients undergoing cataract surgery.¹

The multicenter retrospective study, published in Ophthalmology and Therapy, found that the enhanced monofocal IOLs provided good distance vision as well as functional intermediate vision. The findings add real-world evidence to previous clinical data supporting the intermediate-optimized optics of the enVista Aspire platform.

“Traditional monofocal lenses offer good distance vision, but we know that cataract patients have an increased need and desire for good intermediate vision, particularly given the digital demands of our modern world,” Luc Bonnefoy, president, Surgical, Bausch + Lomb, said in a company announcement. “The results of this study reinforce clinical data showing that the intermediate optimized optics of the enVista Aspire platform, which are designed for a broader depth of focus, can deliver both.”

Six US cataract surgeons contributed cases and completed a retrospective experience survey assessing corrected distance visual acuity (CDVA), uncorrected distance visual acuity (UDVA), uncorrected intermediate visual acuity (UIVA), refractive outcomes, and safety. The analysis included 84 patients and 141 eyes, of which 88 received an enVista Aspire IOL and 53 received an enVista Aspire toric IOL.

Among eyes implanted with enVista Aspire, 97.2% achieved monocular CDVA of 20/25 or better at the last reported follow-up visit. Additionally, 71.3% achieved monocular UDVA of 20/25 or better, and 76.6% achieved monocular UIVA of 20/32 or better.

Results were similar in the enVista Aspire toric group. At the last reported follow-up, 94.9% of eyes achieved monocular CDVA of 20/25 or better, 84.9% achieved monocular UDVA of 20/25 or better, and 93% achieved monocular UIVA of 20/32 or better.

Across both groups, 100% of patients achieved binocular UIVA of 20/32 or better. No serious adverse events were reported.

“The results of clinical studies involving enVista Aspire lenses have been clear, but real-world data has thus far been limited,” said Eric Donnenfeld, MD, lead author of the study and an ophthalmologist with Ophthalmic Consultants of Connecticut. “The outcomes reported in this study not only mirror what I’ve seen in my practice, they also provide evidence that the intermediate optimized optic is indeed having the intended effect in clinical practice.”

The enVista Aspire platform is designed to extend the range of vision of a monofocal IOL beyond distance and into the intermediate range. The lenses also incorporate Bausch + Lomb’s glistening-free optic material and StableFlex technology, which is designed to support controlled unfolding and optic recovery during implantation.

For patients with astigmatism, the enVista Aspire toric platform combines the intermediate-optimized optic with astigmatic correction. According to Bausch + Lomb, the toric platform includes a low-cylinder option beginning at +1.25 D in the United States and +0.90 D at the IOL plane in markets outside the United States. Its AccuSet haptic design is intended to provide rotational stability following implantation.

Reference

1. Donnenfeld, E., Patel, R., Patterson, M. et al. Real-World Experience with Enhanced Monofocal Intraocular Lenses Following Cataract Surgery: A Multicenter Retrospective Case Series. Ophthalmol Ther (2026). https://doi.org/10.1007/s40123-026-01473-3

• Ocugen has dosed the first patient in a 237-patient global phase 3 trial of OCU410 for geographic atrophy secondary to dry AMD
• The study will evaluate a single subretinal administration of the RORA-based modifier gene therapy, with GA lesion growth serving as the primary endpoint

Ocugen has dosed the first patient in a global phase 3 registrational trial evaluating OCU410, an investigational modifier gene therapy for geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD).

The milestone follows the FDA’s July 29, 2026, regenerative medicine advanced therapy (RMAT) designation for OCU410 and completion of a Type B end-of-phase 2 meeting with the agency’s Center for Biologics Evaluation and Research (CBER). According to Ocugen, the meeting resulted in alignment on key elements of the phase 3 program, including its endpoints, dose, adaptive design and use of a single pivotal trial to support a biologics license application (BLA).

“Dosing the first patient in our global phase 3 trial, just weeks after receiving RMAT designation, marks a defining moment for the OCU410 program—and for the millions of people living with geographic atrophy,” Shankar Musunuri, PhD, MBA, chairman, CEO and co-founder of Ocugen, said in a news release.

OCU410 uses an AAV5 vector to deliver the human retinoid-related orphan receptor alpha (RORA) modifier gene through a single subretinal injection. The investigational therapy is designed to address multiple pathways implicated in GA, including complement overactivation, chronic inflammation, oxidative stress and lipid dysregulation.

The global, multicenter, randomized, controlled phase 3 study is expected to enroll 237 patients with GA secondary to dry AMD at sites in the United States, Canada, Europe and Latin America. Participants will be randomized 2:1 to receive either a single 200-µL subretinal injection of OCU410 at 5 × 10^10 vg/mL or no treatment.

The primary endpoint is the rate of change in square root-transformed GA lesion area, measured by fundus autofluorescence at baseline and months 4, 8 and 12 and analyzed using a mixed model for repeated measures.

Secondary endpoints include the proportion of patients experiencing a loss of at least 15 ETDRS letters in low-luminance visual acuity at 2 consecutive visits through month 12. Investigators will also evaluate the rate of ellipsoid zone area loss using spectral-domain optical coherence tomography.

“We are entering a global single phase 3 with a well-defined program: a dose validated in a randomized, controlled Phase 2 study; an FDA-endorsed primary endpoint measuring the rate of lesion growth; and a secondary endpoint assessing functional vision,” Mohamed Genead, MD, chief medical officer of Ocugen, said in the announcement.

Ocugen said the trial is intended to provide the pivotal evidence supporting a BLA submission, which the company anticipates in 2028. Discussions with the European Medicines Agency are ongoing regarding whether the same phase 3 trial could support a marketing authorization application in Europe.

The phase 3 program builds on 12-month findings from the phase 2 ArMaDa study, a multicenter, randomized, controlled trial involving 51 patients with GA secondary to dry AMD.

According to Ocugen, the medium dose selected for phase 3 produced a statistically significant 31% reduction in the GA lesion area growth rate compared with control at 12 months among patients meeting the phase 3 lesion-size criteria of 2.5 mm² to 17.5 mm². The company also reported a 27% reduction in ellipsoid zone area loss compared with control. In a responder analysis, approximately 20% of patients receiving the medium dose showed no disease progression, while 75% demonstrated greater than a 30% reduction in lesion growth at 12 months.

No OCU410-related serious adverse events or adverse events of special interest have been reported to date, according to the company.

Ocugen is positioning OCU410 as a potential one-time treatment that differs mechanistically and administratively from the intravitreal complement inhibitors currently approved for GA in the United States. 

• Samsara Vision promoted Jason Herod to president and CEO, effective April 28, 2026, after he most recently served as the company’s chief commercial officer
• The company said its SING IMT has been implanted in more than 550 patients across 19 countries where the device is approved for use
• Samsara Vision is preparing for the PERSPECTIVE study evaluating SING IMT outcomes in pseudophakic patients with late-stage AMD 

Samsara Vision has promoted Jason Herod to president and chief executive officer, effective April 28, 2026. The announcement comapany comes as the company continues the commercialization and clinical development of its implantable telescope technology for patients with late-stage age-related macular degeneration (AMD).

Mr. Herod joined Samsara Vision in 2021 and most recently served as chief commercial officer, where he was responsible for commercialization of the company’s Smaller-Incision New-Generation Implantable Miniature Telescope (SING IMT). He brings more than 29 years of experience across ophthalmic medical devices, pharmaceuticals and over-the-counter products. Before joining Samsara Vision, he spent 15 years at Alcon, most recently serving as global senior director of presbyopia-correcting IOLs within the company’s surgical business.

He earned a bachelor’s degree in commerce from Saint Mary’s University in Canada and a Master of Business Administration from the University of Toronto.

“I’m grateful for the opportunity to lead Samsara Vision, particularly during a time of immense growth,” Mr. Herod said in a statement. “In CE Referenced countries, where the SING IMT is approved for use, we have seen tremendous excitement and uptake of our device for late-stage AMD, where it has been implanted in over 550 patients in 19 countries.”

Mr. Herod also pointed to the upcoming PERSPECTIVE study as a key component of the company’s clinical strategy. The European clinical trial is designed to evaluate outcomes with the SING IMT in patients with pseudophakic eyes. According to Samsara, PERSPECTIVE is the first study designed to assess outcomes in pseudophakic eyes in a controlled, multinational setting. The company says including patients who have previously undergone cataract surgery could expand the population evaluated for the technology as pseudophakia is common among individuals with late-stage AMD. The study’s primary endpoints will assess safety, visual outcomes, patient selection criteria and rehabilitation strategies.

Samsara Vision also announced several additional leadership appointments. Faustino Vidal Aroca, PhD, has assumed the role of global vice president of clinical and medical affairs, while Syed Rashid has been named global vice president of market access and Europe commercial. Zubair Hussain, PhD, has joined the company as global vice president of regulatory affairs and quality, and Pedro Gonçalves has joined as global vice president of marketing.

• Only 14% of surveyed perimenopausal, menopausal and postmenopausal women recognized dry eye as a menopause-related symptom, while 78% were surprised to learn of the association
• Women experiencing dry eye reported effects on daily activities, including reading (58%), screen use (53%), driving (26%) and productivity (17%)
• The findings point to an opportunity for eye care professionals to increase awareness of dry eye and discuss ocular symptoms with patients during perimenopause and menopause

A new Bausch + Lomb survey suggests that dry eye remains underrecognized among women as a symptom associated with perimenopause and menopause, despite its potential effects on daily activities and quality of life.

According to the company, only 14% of perimenopausal, menopausal and postmenopausal women surveyed recognized dry eye as a menopause-related symptom. By comparison, 79% identified hot flashes as a symptom. Nearly 8 in 10 respondents (78%) said they were surprised to learn that dry eye can be associated with perimenopause or menopause.

“Dry eye symptoms can have a meaningful impact on everyday activities and quality of life, yet they are often not associated with perimenopause and menopause,” Mayssa Attar, PhD, senior vice president of Consumer and Pharmaceutical Research & Development at Bausch + Lomb, said in a statement. “The survey findings highlight an opportunity to increase understanding of how eye health can be affected during these stages of life and encourage women experiencing symptoms to speak with an eye care professional.”

Hormonal changes occurring during perimenopause and menopause can affect tear production, tear quality and tear evaporation, potentially contributing to symptoms including burning, irritation, fluctuating vision and ocular discomfort. Among respondents who experienced dry eye symptoms during perimenopause, menopause or postmenopause, 80% said the symptoms came as a surprise.

The survey also examined how dry eye affects everyday activities. Among perimenopausal, menopausal and postmenopausal women experiencing dry eye, 58% reported difficulty reading and 53% reported difficulty using screens. Additionally, 26% reported difficulty driving, while 17% said dry eye reduced their productivity.

The findings pointed to broader challenges surrounding symptom management during the menopause transition. More than 43% of respondents said managing their symptoms was overwhelming, and more than 40% said they did not know where to start when managing perimenopausal or menopausal symptoms.

• Medicel is expanding its Soft Tip I/A portfolio with Bicel Soft Tip I/A Terralution, a bimanual irrigation and aspiration instrument for cataract surgery
• The device uses a flexible polymer tip and ergonomic cannula and handle design intended to support gentle tissue interaction during cortical removal and capsular cleanup
• Medicel will introduce the instrument at ESCRS 2026 in London

Medicel AG announced the expansion of its Soft Tip I/A portfolio with the launch of Bicel Soft Tip I/A Terralution, a bimanual irrigation and aspiration instrument designed to support gentle tissue interaction during cataract surgery.

The Swiss manufacturer plans to introduce the instrument at the European Society of Cataract and Refractive Surgeons (ESCRS) 2026 Congress, scheduled for September 11-15 in London.

According to Medicel, the new device extends the company’s soft-tip approach from its Swiss Coaxial Soft Tip I/A platform into bimanual I/A. The instrument incorporates a flexible polymer tip intended to provide controlled interaction with delicate ocular tissues during cortical removal and capsular cleanup.

Posterior capsule rupture remains an important complication and quality indicator in cataract surgery, and published research has reported that rupture frequently occurs during cortical removal. Medicel noted that conventional metal I/A tips can contain microscopic internal irregularities or sharp edges that may contact the posterior capsule if tissue is inadvertently aspirated.

The company said the soft-tip design increases the separation between delicate tissue and exposed metal, with the goal of supporting safer tissue handling during irrigation and aspiration.

Bicel Soft Tip I/A also incorporates what Medicel describes as an “aeroplane shape” cannula design intended to facilitate cortex and epinucleus removal as well as removal of residual lens epithelial cells. The handpiece includes a balanced handle designed to support a natural hand position and a textured, nonslip grip.

“With the Bicel Soft Tip I/A handpiece, we are expanding our Soft Tip I/A portfolio by bringing the philosophy of gentle tissue interaction to bimanual I/A,” Monika Maria Schulten, chief commercial officer at Medicel AG, said in a statement. “The new instrument reflects our commitment to listening to surgeons’ needs and developing solutions that combine performance, ergonomics, and sustainability.”

The new instrument is part of Medicel’s Terralution product family, which incorporates sustainability-focused materials and manufacturing processes. According to the company, the handpiece uses a 75% bio-based high-performance material and is packaged in a recyclable grass-paper box.

Medicel said the product is manufactured in Switzerland using electricity generated entirely from local renewable hydropower.

• Innoptix says more than 5,000 patients have enrolled on Eyejourney within 6 months of the ophthalmic digital platform’s commercial launch
• Eyejourney combines patient education, electronic consent, eye drop compliance monitoring and multichannel patient engagement across the surgical pathway.

Rayner’s digital health division, Innoptix, announced that more than 5,000 patients have been enrolled on Eyejourney, its AI-powered ophthalmic patient education platform, 6 months after its commercial launch.

According to the company, Eyejourney has now been adopted across clinics in the United Kingdom and international markets. The milestone comes alongside clinical data presented at DOC 2026 suggesting use of the platform may reduce consultation and chair time by up to 40%.¹

Eyejourney is designed to support patients and clinical teams throughout the ophthalmic surgical pathway. The platform incorporates preoperative and postoperative education, electronic consent, eye drop compliance tracking and patient engagement through app push notifications, SMS and email.

Innoptix said the platform was developed with input from a clinical advisory board, patient-centered research and ophthalmic specialist developer Wolfson Research.

“Our Innoptix team is breaking new ground, and it's exciting to see the impact in action,” Tim Clover, CEO of Rayner, said in a statement. “Passing 5,000 patients within 6 months, with real clinical data behind it, tells us we're solving a genuine problem, not adding technology for its own sake.”

One feature of Eyejourney allows surgeons to create personalized video messages using digital avatars, enabling patients to revisit instructions after leaving the clinic. Clinical teams can also use a central dashboard to capture electronic consent, monitor patients’ engagement with educational materials, and track adherence to prescribed eye drops.

The potential impact on clinical workflow was highlighted in research presented by Tabitha Neuhann, MD, at DOC 2026 in Nuremberg, Germany, in June. The presentation examined an AI-integrated digital pathway intended to improve ophthalmic patient education and reduce perioperative anxiety.

“When patients understand what's happening, through the structured education videos and drop compliance tracker, they arrive better prepared and need less reassurance in the room,” Dr. Neuhann, a vision correction surgeon at Ophthalmologikum Dr. Neuhann, said in a statement.

She added that reducing the need for additional reassurance can free up chair time for clinicians to focus on patient care.

Innoptix said it plans to expand Eyejourney’s AI capabilities across the surgical and postoperative pathway as development of the platform continues.

The company will demonstrate Eyejourney at Rayner’s booth during the European Society of Cataract and Refractive Surgeons (ESCRS) 2026 meeting, scheduled for September 11-14 in London.

Reference

Neuhann T. AI-Integrated Digital Pathway for Enhancing Ophthalmic Patient Education and Reducing Perioperative Anxiety. Presented at DOC 2026; June 18-20, 2026; Nuremberg, Germany.

• X-Cel Specialty Contacts and Essilor Custom Contacts have launched Lunara, an FDA PMA-approved overnight orthokeratology lens made from 180 Dk Optimum Infinite material
• Lunara uses familiar tangential, reverse-geometry fitting principles and offers flexible optic zone and diameter options, along with fitting and certification resources and consultant support

X-Cel Specialty Contacts and Essilor Custom Contacts have announced the launch of Lunara, a new FDA-approved overnight orthokeratology lens designed around familiar tangential fitting principles.

The lens is manufactured in Optimum Infinite (tisilfocon A), a 180 Dk material intended to provide high oxygen permeability for overnight wear. According to the companies, Lunara combines tangential, reverse-geometry design principles with flexible optic zone and diameter options, allowing practitioners to tailor lens selection to individual patient needs.

The design is intended to provide a familiar fitting approach for clinicians already working with established tangential-design orthokeratology lenses while also offering an accessible option for practitioners adding orthokeratology to their practices.

“Whether a doctor is new to fitting orthokeratology or already fitting today’s leading tangential-design lenses, Lunara is built around familiar clinical principles,” Derrell James, vice president and general manager of X-Cel Specialty Contacts and Essilor Custom Contacts, said in the announcement.

Mr. James added that the lens combines “premium material performance, flexible parameters, fast turnaround and direct access to knowledgeable specialty contact lens consultants.”

The launch is supported by a dedicated Lunara Lens Selector as well as fitting, certification and educational resources. The materials are designed to assist practitioners throughout the fitting process, including initial lens selection, follow-up and troubleshooting.

Practitioners also have access to NCLE-certified specialty contact lens consultants by phone from 8 a.m. to 8 p.m. Eastern Time, Monday-Friday. According to the companies, dedicated assistance is available for practices transitioning from other tangential-fitting lens systems.

Additional features highlighted by X-Cel and Essilor include flexible optic zone and diameter options and fast turnaround.

As part of the U.S. launch, X-Cel Specialty Contacts is offering a 50% discount on Lunara for US accounts through December 31, 2026. The promotion is aimed at practices adopting the lens, including those looking to add another tangential-design option to an existing orthokeratology program.

Practitioners can access product information, fitting resources and certification materials through X-Cel Specialty Contacts’ Lunara website.

• Kiora Pharmaceuticals licensed South Korean development and commercialization rights for KIO-301 to Chong Kun Dang, receiving $1 million upfront with potential milestone payments and future royalties
• Kiora expects Chong Kun Dang, Laboratoires Théa, and Senju Pharmaceutical to coordinate around a single global phase 3 trial of KIO-301 in retinitis pigmentosa
• KIO-301 is designed to restore light sensitivity to retinal ganglion cells through a mutation-agnostic mechanism, potentially allowing its use across multiple inherited retinal diseases

Kiora Pharmaceuticals has licensed development and commercialization rights for KIO-301 in South Korea to Chong Kun Dang Pharmaceutical Corporation (CKD), expanding the geographic partnering network for the investigational retinal therapy.

Under the agreement, Kiora will receive a $1 million upfront payment and is eligible for additional development and regulatory milestone payments, as well as royalties on future KIO-301 sales in South Korea. Specific values for the potential milestone payments and royalty rates were not disclosed. CKD, based in Seoul, will be responsible for development and commercialization activities in South Korea.

KIO-301 is a molecular photoswitch being developed initially for retinitis pigmentosa (RP). The therapy is designed to restore light sensitivity to retinal ganglion cells after photoreceptors have degenerated, using an approach that does not depend on the genetic mutation responsible for a patient's disease.

“KIO-301 is a molecular photoswitch designed to restore light sensitivity in degenerated retinal cells through a novel and elegant gene mutation-agnostic mechanism,” Young-Joo Kim, president of CKD, said in a statement.

Kiora said it expects its development and commercialization partners—Laboratoires Théa, Senju Pharmaceutical, and CKD—to coordinate their efforts around a single global Phase 3 clinical trial evaluating KIO-301 in RP.

The latest agreement adds South Korea to Kiora's partnered markets for the program. According to the company, partnerships now cover major markets including the United States, Europe, Japan, China, and South Korea.

With its global KIO-301 partnerships established, Kiora said it plans to focus internal resources on other areas of its pipeline. These include advancing KIO-104 for retinal inflammation and fibrosis, and evaluating the company's ion channel modulators for potential therapeutic applications outside ophthalmology, including epilepsy. Kiora also said it will evaluate potential strategic transactions that could expand its pipeline.

KIO-301's mutation-agnostic mechanism could potentially allow the therapy to address a broader population of patients with inherited retinal degeneration than treatments directed at individual genetic variants.

Although RP is the initial indication under development, Kiora has identified other inherited retinal diseases, including choroideremia and Stargardt disease, as potential applications for the technology.

• A Bayesian meta-analysis of 54 studies and more than 6.8 million cataract surgeries found antibiotic injection was associated with an approximately 79% reduction in the odds of postoperative endophthalmitis
• Investigators calculated a 100% posterior probability of clinically meaningful benefit and a 99.1% probability that future studies would confirm the finding

Intraoperative antibiotic injection was associated with a substantially lower risk of postoperative endophthalmitis compared with conventional topical eye drop regimens following cataract surgery, according to findings from a large Bayesian meta-analysis.¹

The analysis included 54 studies encompassing 6,867,422 cataract surgeries, including 3,501,802 procedures in which antibiotic injection therapy was administered. Investigators reported that antibiotic injection was associated with an approximately 79% reduction in the odds of postoperative endophthalmitis compared with conventional postoperative regimens.

The study was published online August 25, 2026, in the Journal of Cataract & Refractive Surgery.

Investigators conducted a systematic search of PubMed, Embase, and the Cochrane Library for studies evaluating antibiotic injections during cataract surgery compared with conventional postoperative regimens. The researchers used a Bayesian random-effects meta-analysis to estimate the overall treatment effect and between-study heterogeneity. Treatment effects were expressed as odds ratios (ORs) with 95% credible intervals (CrIs). 

Across the 54 studies, antibiotic injection was associated with an OR of 0.208 for postoperative endophthalmitis compared with standard regimens (95% CrI, 0.161-0.268). The Bayesian analysis also found a 100% posterior probability that antibiotic injection provided a clinically meaningful benefit, which investigators defined as an OR below 0.80. Additionally, the model estimated a 99.1% probability that future studies would confirm the observed benefit. Sensitivity analyses supported the primary findings.

The findings provide additional evidence supporting intraoperative antibiotic administration as an infection-prevention strategy and may also bolster interest in approaches designed to reduce patients' reliance on postoperative drops.

The analysis specifically evaluated the risk of endophthalmitis associated with antibiotic injection and does not, based on the published abstract, provide detailed comparisons of individual antibiotic agents, dosing strategies, or injection routes. The available results also do not report secondary safety outcomes associated with specific intracameral or subconjunctival protocols.

Because the meta-analysis incorporated both randomized and nonrandomized evidence, differences among the underlying studies should also be considered when interpreting the pooled treatment effect. Still, the investigators concluded that antibiotic injection during cataract surgery was associated with a significant reduction in postoperative endophthalmitis risk, with sensitivity analyses supporting the robustness of the finding.

Reference

1. Ramos M, Barbosa LM, Ramos SM, et al. Antibiotic injection in cataract surgery and risk of endophthalmitis: a Bayesian meta-analysis. J Cataract Refract Surg. Published online August 25, 2026. doi:10.1097/j.jcrs.0000000000002045.

• A human stem cell-derived 3D retina model showed that primary RPE dysfunction can initiate photoreceptor degeneration in CLN3-Batten disease
• Reduced acid ceramidase levels and associated lipid abnormalities emerged as a potential mechanism contributing to retinal damage
• Recombinant human acid ceramidase improved cellular health and reduced retinal degeneration in preclinical models, supporting further investigation as a potential therapy

Researchers at University of Rochester Medicine have developed a 3D human stem cell-derived retina model that sheds new light on the mechanisms underlying early vision loss in CLN3-Batten disease and identifies recombinant human acid ceramidase as a potential therapeutic approach.

The study, published in Science Translational Medicine, suggests that dysfunction of the retinal pigment epithelium (RPE) may be sufficient to initiate photoreceptor degeneration in CLN3-Batten disease.¹ The findings challenge the view that retinal degeneration in the inherited disorder is driven primarily by abnormalities within neurons and photoreceptors.

CLN3-Batten disease is a rare inherited neurodegenerative disorder in which vision loss frequently occurs before progressive neurological decline. For affected children, declining vision can interfere with reading, learning, mobility, and independence years before other neurological manifestations emerge.

Studying the earliest stages of retinal degeneration has been difficult because the disease affects interactions between photoreceptors and supporting cells within the retina. To better reproduce those interactions, investigators created a 3D human stem cell-derived model designed to mimic the relationship between photoreceptors and the RPE.

“Although molecular and cellular changes associated with the disease have been shown in other models, this retina model captures the earliest and most consistent pathology seen in patients, including photoreceptor outer segment loss and degeneration,” Ruchira Singh, PhD, associate professor in the University of Rochester Medicine Flaum Eye Institute and lead author of the study, said in a University of Rochester Medicine article. 

Using the model, investigators found that disease-related abnormalities confined to RPE cells could lead to photoreceptor degeneration. The observation points to the RPE as an important contributor to the retinal manifestations of CLN3-Batten disease and could help explain why visual impairment occurs early in the disease course.

“Our data shows that primary RPE dysfunction is sufficient to instigate photoreceptor degeneration,” Dr. Singh said. “This may help explain why vision loss is one of the earliest symptoms in CLN3-Batten disease.”

The findings could also influence therapeutic development by indicating that preservation of vision may require targeting the broader photoreceptor-RPE unit rather than photoreceptors alone.

Investigators also identified reduced levels of acid ceramidase, an enzyme involved in cellular lipid regulation, in CLN3-Batten disease cells. Reduced enzyme activity was associated with lipid abnormalities that may contribute to retinal degeneration.

The team subsequently evaluated recombinant human acid ceramidase (rhAC) as a potential treatment in laboratory-grown retinal tissue and a large-animal model of CLN3-Batten disease. Treatment improved measures of cellular health and reduced signs of retinal degeneration, according to the researchers.

“rhAC is a strong therapeutic candidate because it restores enzyme activity in diseased cells without affecting healthy ones,” Dr. Singh said.

The results add a potential enzyme-based strategy to a therapeutic landscape that already includes investigational gene therapies and approaches targeting lipid metabolism. The researchers indicated that recognizing the role of RPE dysfunction could help inform these efforts by emphasizing the need to address both photoreceptors and their supporting cells.

Beyond its therapeutic implications, the 3D retina model could provide investigators with a human-relevant platform for studying disease mechanisms and screening candidate treatments. The approach may also have applications in other retinal disorders involving dysfunction of the photoreceptor-RPE interface.

Additional studies will be needed to establish the long-term safety and efficacy of rhAC before clinical testing and to determine whether the strategy could affect manifestations of CLN3-Batten disease beyond retinal degeneration.

The study included collaborators from the University of Rochester, University of Tasmania, Cleveland Clinic, and Icahn School of Medicine. Funding was provided by the National Eye Institute, ForeBatten Foundation, and Mangurian Foundation.

Reference

1. Han J, Foley N, Dalvi S, et al. A 3D human retina model reveals a non-cell-autonomous and non-neuronal mechanism of photoreceptor loss in a lysosomal storage disorder. Sci Transl Med. 2026;18(864):eady7616. doi:10.1126/scitranslmed.ady7616

• Cataract surgery performed in outreach camps was associated with a lower adjusted probability of achieving presenting visual acuity of 6/18 or better than surgery performed at fixed facilities, 60.6% versus 66.6%
• Among fixed facilities, private hospitals had better outcomes than government hospitals, whereas outcomes at NGO and government hospitals were statistically similar
• Visual outcomes improved across all cataract surgery delivery models over time, but differences between settings persisted, highlighting potential opportunities to improve outreach and public-sector cataract services

Cataract surgery performed in outreach camps was associated with poorer visual outcomes than surgery conducted at fixed facilities, according to a large international analysis published in the British Journal of Ophthalmology.¹

The study, which included 41,881 cataract-operated eyes across 61 countries, also identified differences among fixed-facility providers. Private hospitals had better outcomes than government hospitals, while outcomes at nongovernmental organization (NGO) hospitals were similar to those at government facilities.

The findings suggest that although cataract surgical outcomes have improved across different models of care, persistent differences associated with where surgery is delivered could affect efforts to reduce avoidable vision impairment.

Investigators conducted a pooled cross-sectional analysis using data from 168 population-based "Rapid Assessment of Avoidable Blindness" surveys. The analysis included cataract-operated eyes from adults aged 50 years and older and was restricted to surgeries performed between 2000 and 2020.

The primary outcome was presenting visual acuity of 6/18 or better following cataract surgery. Researchers used multilevel logistic regression to examine the relationship between surgical setting and visual outcomes, accounting for clustering at the country, survey, cluster and individual levels. Analyses were adjusted for age at surgery, sex, year of surgery and Global Burden of Disease super-region.

Outreach camps accounted for 9.7% of cataract procedures included in the analysis. The adjusted probability of achieving presenting visual acuity of 6/18 or better was 60.6% following surgery in an outreach camp compared with 66.6% following surgery at a fixed facility.

Overall, outreach surgery was associated with significantly lower odds of achieving this level of visual acuity compared with surgery at fixed facilities (OR, 0.59; 95% CI, 0.50-0.70).

The researchers separately examined outcomes among government, NGO and private hospitals operating as fixed facilities.

The adjusted probability of achieving presenting visual acuity of 6/18 or better was 64.8% at government hospitals, 66.8% at NGO hospitals, and 69.5% at private hospitals.

Compared with government hospitals, NGO hospitals did not demonstrate a statistically significant difference in outcomes (OR, 1.21; 95% CI, 0.95-1.53). Patients undergoing surgery at private hospitals, however, had greater odds of achieving presenting visual acuity of 6/18 or better than those treated at government hospitals (OR, 1.56; 95% CI, 1.25-1.94).

Visual outcomes improved over time across all of the cataract surgery delivery models evaluated. However, the differences between surgical settings persisted, according to the investigators.

The findings have potential implications for global initiatives focused on effective cataract surgical coverage, which considers not only whether patients receive cataract surgery but also whether surgery produces an adequate visual outcome.

The investigators concluded that in regions where outreach programs perform a substantial share of cataract procedures, poorer outcomes associated with these services could limit improvements in effective cataract surgical coverage.

Reference

1. Arazi M, Burd D, Henok SH, et al; Variation in cataract surgical outcomes by facility type: evidence from 168 population-based surveys in 61 countries. Br J Ophthalmol. Published online August 26, 2026. doi:10.1136/bjo-2026-329992.

• The UK government aims to restore the NHS standard of treating 92% of patients within 18 weeks of referral by March 2029, including those awaiting ophthalmology care
• Planned reforms include standardized glaucoma pathways, improved referral technology, expanded ophthalmic surgical hubs, and home-based glaucoma services through NHS Online

The UK government has outlined a series of initiatives intended to reduce ophthalmology waiting times, address regional disparities, and move more eye care into community and digital settings.

The measures were detailed in a written parliamentary response published August 25, following a question from Baroness Redfern about plans to publish ophthalmology waiting-time data and address inconsistent commissioning of sight-saving treatment across England.

Baroness Merron, parliamentary under-secretary of state for health and social care, said the government remains committed to restoring the NHS constitutional standard under which 92% of patients begin consultant-led treatment within 18 weeks of referral by March 2029.

Across all medical specialties, the proportion of patients waiting less than 18 weeks increased from 65.7% in July 2024 to 74.1% in May 2026, according to the response. The government did not provide a separate national percentage for ophthalmology.

Several initiatives are being implemented specifically to improve eye care services. NHS England accelerator pilot programs have demonstrated that better information technology connectivity and a single point of access can accelerate referrals and allow more patients to be managed in community settings, the government said.

NHS England’s "Getting It Right First Time" program also released best-practice guidance for glaucoma care in May 2026. The document is expected to be the first in a series covering ophthalmic conditions and is intended to standardize patient pathways across England.

According to the government, greater pathway consistency should help ophthalmology teams identify and prioritize patients with the most complex conditions or the greatest risk of vision loss.

The response also highlighted the planned introduction of NHS Online in 2027. Patients participating in glaucoma pathways are expected to have the option of receiving certain elements of specialist care from home. Across all specialties, NHS Online is projected to deliver the equivalent of as many as 8.5 million appointments and assessments during its first 3 years.

The government also plans to expand surgical hubs, which provide protected capacity for elective procedures. Ophthalmology is one of six specialties targeted by that initiative. To address geographic variations in access and outcomes, commissioners will continue to receive data through the Public Health Outcomes Framework eye-health indicator. The measure tracks sight loss associated with age-related macular degeneration, glaucoma, and diabetic retinopathy.

The government noted that integrated care boards are legally required to fund medicines recommended by the National Institute for Health and Care Excellence, including approved treatments for ophthalmic conditions such as age-related macular degeneration.

The parliamentary response did not announce a new ophthalmology-specific waiting-time publication. However, it pointed to existing NHS data and described a broader strategy centered on digital access, community-based care, standardized pathways, and expanded surgical capacity.

• California lawmakers have passed AB 2756, which would establish performance measures examining utilization, access, and availability of vision services for children enrolled in Medi-Cal
• Data cited by the California Optometric Association indicate that 84% of school-age Medi-Cal enrollees are not receiving basic primary eye care, with utilization declining over the past decade
• The bill now heads to Gov. Gavin Newsom, with supporters arguing that better data could help California identify care gaps and reduce reliance on emergency departments for nonemergent eye conditions

California lawmakers have passed legislation that would establish new performance measures for children's vision services under Medi-Cal, sending the measure to Gov. Gavin Newsom for consideration.

AB 2756, authored by Assemblymember Patrick Ahrens and sponsored by the California Optometric Association (COA), is intended to strengthen state oversight of the utilization, access, and availability of vision services. The legislation received unanimous bipartisan support in the Assembly and Senate, according to the COA.

The measure comes amid concerns about low utilization of primary eye care among children enrolled in Medi-Cal. An analysis of California Department of Health Care Services (DHCS) data cited by the association found that 84% of school-age Medi-Cal enrollees are not receiving basic primary eye care services.

“When California is paying Medi-Cal plans for children’s primary eye care but only one in six school-age children enrolled is receiving it, we need better tools to understand where children are falling through the cracks and how we can improve access,” Rachelle Lin, OD, president of the COA, said in a statement.

According to the data cited by the COA, the proportion of school-age children receiving primary eye care declined from 19.2% in 2015-2016 to 15.8% during 2022-2024. Medi-Cal managed care plans in 47 counties reportedly served a smaller proportion of children than they had 7 years earlier. In 23 counties, the proportion of children receiving primary eye care services declined by more than 50%.

AB 2756 would require California to establish performance measures assessing the utilization, access, and availability of vision services. Supporters say the resulting data could help policymakers identify disparities in care and determine where improvements are needed in access to primary vision services and follow-up treatment.

The coalition supporting the legislation includes optometrists, pediatricians, and education advocates, according to the COA.

Supporters are also pointing to the potential health care costs associated with inadequate access to routine eye care. Research cited by the association found that more than 300,000 California children visited emergency departments for nonemergent eye conditions over a 10-year period.

“AB 2756 will provide state policymakers with the critical data needed to connect children with the eye care they need, helping prevent non-emergent eye conditions from being treated in costly emergency departments when they could be more appropriately addressed through routine outpatient care,” Dr. Lin said.

• Zeiss is introducing a cataract-only configuration of the DORC EVA Nexus ophthalmic surgical system, with an initial European rollout planned for September 
• The configuration includes up to 4 programmable cataract-grade presets as well as VacuFlow VTi fluidics, Smart IOP pressure management, and EVA Equiphaco technology
• Zeiss is positioning the system within its Cataract Workflow portfolio, with global availability expected to expand subject to regional regulatory approvals

Zeiss announced the availability of the DORC EVA Nexus ophthalmic surgical system in a dedicated cataract configuration, expanding the platform with features designed to provide cataract surgeons with streamlined performance, stability, and control in the operating room.

The cataract-only configuration is scheduled to make its global debut at the 2026 European Society of Cataract and Refractive Surgeons (ESCRS) Congress in London. According to Zeiss, the system will initially become available in select European countries beginning in September 2026, with broader global availability to follow pending regional regulatory approvals.

The configuration includes a cataract grade selection feature with as many as 4 programmable presets. The presets allow surgeons to select optimized phacoemulsification, aspiration, and irrigation settings based on the surgical step and cataract grade. Settings can be activated through either the footswitch or system screen.

Zeiss also said the DORC EVA Nexus cataract configuration is being integrated into its Cataract Workflow portfolio.

“With the newly configured DORC EVA Nexus cataract solution, Zeiss’ advanced technology is redefining how cataract surgeons can operate in the OR—designed for streamlined performance, stability and control—supporting surgical decisions and procedural precision,” Dominik Beck, MD, head of the Posterior Surgery Business Sector at Zeiss Medical Technology, said in the announcement.

Among the technologies incorporated into the system are the VacuFlow VTi pump, Smart IOP, and EVA Equiphaco.

VacuFlow VTi uses Valve Timing Intelligence to provide either pulsation-free flow or responsive vacuum during cataract procedures. According to the company, the fluidics technology is intended to improve efficiency and surgeon control.

Smart IOP is designed to automatically compensate for pressure losses and maintain constant intraocular pressure. Zeiss reported that the technology provides more stable, lower anterior chamber pressure, and up to 73% greater responsiveness, including during post-occlusion breaks.

For phacoemulsification, the system incorporates the compact EVA Sure Touch handpiece and EVA Equiphaco range of phaco tips with fitted, color-coded sleeves. Zeiss said the combination is designed to support chamber stability, ultrasound efficiency, and surgeon control.

A customizable wireless Dual Linear footswitch provides independent control of aspiration and ultrasound.

• The FDA has accepted the NDA for NCX 470 for lowering IOP in patients with open-angle glaucoma or ocular hypertension and set April 30, 2027, as the PDUFA target date
• The application is supported by the phase 3 Mont Blanc and Denali trials, which Nicox said demonstrated IOP reductions of up to 10 mm Hg with a favorable safety profile
• Nicox partner Kowa is targeting a US launch in the second half of 2027 if NCX 470 receives FDA approval

The FDA has accepted the new drug application (NDA) for Nicox's NCX 470 (bimatoprost grenod), a nitric oxide-donating bimatoprost eye drop being developed to lower IOP in patients with open-angle glaucoma or ocular hypertension,

The agency set April 30, 2027, as the Prescription Drug User Fee Act (PDUFA) target date for its decision on the application. FDA acceptance indicates that the NDA is sufficiently complete to proceed to formal review but does not constitute approval of the investigational therapy.

Kowa, Nicox's exclusive US licensee for NCX 470, submitted the NDA on June 30, 2026. The drug candidate is known as K-911 in Kowa’s publications.

"The FDA's acceptance of the NCX 470 NDA for filing is the next key step towards the approval of NCX 470 in the US, which would lead to a commercial launch in the second half of 2027," Gavin Spencer, CEO of Nicox, said in a company announcement.

"The FDA's acceptance of the NDA for K-911 marks an important milestone as we work toward bringing a potential new treatment option to people living with open-angle glaucoma or ocular hypertension," said Joe Barna, CPA, Chief Executive Officer and President of Kowa Pharmaceuticals. "We're proud to bring Kowa's decades of global ophthalmology experience to the U.S. eye care community, and we look forward to working with the FDA throughout the review process."

The NDA for NCX 470, which combines bimatoprost with nitric oxide donation, is supported by results from the phase 3 Mont Blanc and Denali clinical trials. Together, the studies were designed to satisfy efficacy and safety requirements supporting regulatory applications in the United States and China. According to Nicox, the trials demonstrated clinically meaningful IOP reductions of up to 10 mm Hg with a favorable safety profile.

In February 2024, Kowa and Nicox S.A. entered into an exclusive licensing agreement for the development, manufacturing and commercialization of K-911/NCX 470 in Japan, followed by an agreement in July 2025 granting Kowa rights to develop and commercialize K-911/NCX 470 in the United States and other licensed territories. Nicox, which discovered and developed K-911/NCX 470 and led the Mont Blanc and Denali Phase 3 trials, continues to provide development expertise and support, while Kowa is responsible for U.S. regulatory and commercialization activities. 

• The FDA granted De Novo marketing authorization to Avulux, establishing a new device classification for precision optical filters intended to decrease the impact of light sensitivity in patients with episodic migraine
• Avulux filters light at 480 nm and 590 nm while transmitting the remaining visible spectrum and is indicated for patients aged 12 years and older
• The lenses can be dispensed with or without a vision prescription and are intended to complement, rather than replace, patients' usual migraine care and medication use

The FDA has granted De Novo marketing authorization to Avulux for its precision light-filtering lenses designed to decrease the impact of light sensitivity in patients with episodic migraine, establishing a new FDA-recognized device classification for the technology.

According to Avulux, the authorization applies to patients aged 12 years and older who have been diagnosed with episodic migraine. The company said the decision provides patients, eye care professionals, other healthcare providers, and commercial partners with a defined regulatory framework for understanding the device and its intended use.

The FDA's De Novo pathway provides a route for marketing novel medical devices for which there is no legally marketed predicate device. In the case of Avulux, the authorization establishes a classification for a precision optical filter intended to address migraine-associated light sensitivity.

Avulux is designed to block light at wavelengths of 480 nm, in the high-blue range, and 590 nm, in the red/amber range, while allowing light from the remainder of the visible spectrum to pass through. The lenses are worn similarly to conventional eyeglasses and can be produced with or without a patient's vision prescription.

The device is intended to complement rather than replace existing migraine treatment. According to the indication described by the company, use of Avulux should not alter the usual care of patients with episodic migraine, including their medication use.

"For a long time, light sensitivity was seen as just a symptom of migraine. That thinking has changed," Charles Posternack, co-founder and CEO of Avulux, said in the company's announcement. "There is growing recognition that light sensitivity is a serious medical concern in its own right."

Mr. Posternack added that the FDA authorization provides patients and clinicians with an option specifically designed to manage the effects of light in people with migraine.

Photophobia, or light sensitivity, is among the common symptoms associated with migraine and can substantially interfere with patients' daily activities. Avulux cited estimates indicating that migraine affects nearly 15% of the global population and more than 1 billion people worldwide, including more than 45 million people in the United States. The company also noted that light sensitivity occurs in as many as 90% of people with migraine and that light or glare may trigger a substantial proportion of migraine attacks.

The authorization extends to adolescents aged 12 years and older, a population in which migraine can affect school attendance, activities, and quality of life.

The FDA authorization may give optometrists and other eye care professionals a more defined role in helping manage migraine-associated light sensitivity. Patients can obtain the lenses through participating eye care providers, optical practices, and authorized partners, according to Avulux.

Avulux said the FDA reviewed clinical evidence supporting the device, including randomized controlled trials and real-world experience. According to the company, its lenses have been dispensed to more than 50,000 wearers, and its network includes more than 1,400 eye care providers in the United States and Canada.

• Sightview has launched an updated EHR and practice management platform designed specifically for ophthalmology practices
• The platform introduces a redesigned interface, streamlined workflows, an enhanced Patient-at-a-Glance feature, and functionality spanning optical through surgical ophthalmology

Sightview has launched a new electronic health record (EHR) and practice management (PM) platform for ophthalmologists, introducing updated workflows, a redesigned user interface, and expanded clinical information displays while retaining familiar elements of the company’s existing ophthalmology software.

The company said the new platform builds on its established ophthalmology EHR and PM technology, with an emphasis on reducing friction in daily clinical and administrative tasks. The updated technological foundation is also designed to support future enhancements and integrations.

“Sightview has built a large and loyal customer base by keeping our focus squarely on the unique needs and challenges of the eyecare specialty,” said Tycene Fritcher, CEO of Sightview. “We listened carefully to user feedback to keep the best parts of our solutions intact, while uncovering opportunities to modernize and improve usability.”

According to Mr. Fritcher, the resulting platform offers a cleaner user interface while seeking to eliminate unnecessary steps from routine tasks.

Developed in collaboration with ophthalmologists and other eye care clinicians, the platform features standardized colors and simplified screen views intended to make important information easier to identify. Sightview also updated workflows to more closely reflect how clinicians deliver care while preserving familiar processes for existing users.

An enhanced Patient-at-a-Glance feature provides clinicians with a concise view of a patient’s clinical context, including summaries, history, and trends in findings, laboratory results, and vital signs from previous encounters. The platform is also designed to provide end-to-end functionality spanning optical care through surgical ophthalmology. Sightview said a single chart can follow patients across their care journey, including encounters with technicians, optometrists, and ophthalmologists.

Existing Sightview ophthalmology customers are currently transitioning to the new platform, according to the company. The solution is also available to new customers.

• TECLens closed a $10 million Series A2 extension financing, with participation from existing investors 
• The funding will support expansion of the company's first-in-human qCXL clinical program, next-generation system development, regulatory planning, and preparations for an IDE submission
• TECLens' CXLens System is being developed to reshape the cornea through patterned ultraviolet light and targeted cross-linking without cutting or removing corneal tissue

TECLens announced it has closed a $10 million Series A2 extension financing to support clinical development of its quantitative corneal cross-linking technology, including expansion of a first-in-human program evaluating the approach for noninvasive refractive vision correction.

The clinical-stage ophthalmic medical device company said the additional capital will support continued generation of proof-of-concept data for its qCXL platform, development of its next-generation system, refinement of its regulatory strategy, and preparations for an investigational device exemption submission.

The financing follows the initiation of TECLens' first-in-human proof-of-concept study, which is evaluating the company's approach to reshaping the cornea without cutting or removing tissue. TECLens said it expanded the financing round following investor interest, including participation from strategic investors entering the syndicate.

Existing investors participated in the financing, including Johnson & Johnson through its corporate venture capital organization, Johnson & Johnson Innovation – JJDC Inc.

"This financing reflects the significant progress TECLens has made in advancing our proof-of-concept clinical study and the growing confidence in our technology," Madhu Ayyagari, PhD, CEO of TECLens, said in a statement.

Dr. Ayyagari, who became CEO in June, added that early progress in the program has reinforced the potential of qCXL as an alternative approach to refractive vision correction. The new financing will allow the company to expand its clinical program, collect additional data, and advance its CXLens platform, he said.

The company's CXLens System uses personalized, patterned ultraviolet light to reshape the cornea while preserving the epithelium. TECLens' qCXL technology is designed to create molecular bonds at targeted locations within the cornea, strengthening and reshaping the tissue to produce refractive correction without the cutting or tissue removal associated with conventional surgical refractive procedures. The system pairs a proprietary treatment-planning engine with real-time ultrasound monitoring to guide execution of individualized treatment plans, according to the company.

TECLens announced earlier this year that it had treated the first patient in its first-in-human proof-of-concept study of qCXL for noninvasive refractive vision correction. The current clinical program is evaluating patients with refractive errors, with a particular focus on presbyopia.

The company said it plans to provide updates on the clinical development program at the European Society of Cataract and Refractive Surgeons (ESCRS) meeting in London and the American Academy of Ophthalmology (AAO) annual meeting in New Orleans. 

• Bausch + Lomb plans to advance its lifitegrast/PFHO dry eye combination into phase 3 using a Day 15 primary endpoint after the phase 2 study produced a significant prespecified Day 15 result
• BL1332 significantly reduced pain intensity in a phase 1b capsaicin challenge study, providing clinical evidence supporting TRPV1 blockade as a potential approach to ocular surface pain

Bausch + Lomb is advancing two investigational ophthalmic therapies following new clinical results, with a dual-action dry eye treatment headed for phase 3 development and the TRPV1 antagonist BL1332 continuing development for ocular surface pain.

The company reported results from a phase 2 study of its combination of 5% lifitegrast and perfluorohexyloctane (PFHO), as well as a phase 1b study evaluating BL1332 0.30% ophthalmic solution in a capsaicin-induced ocular pain model.

“Helping people see better to live better starts with tackling the challenges patients still face every day,” Brent Saunders, CEO of Bausch + Lomb, said in a news release. “These results support our approach to developing differentiated therapies that have the potential to address significant unmet needs and change the standard of care in eye health.”

Dual-action dry eye candidate moves toward Phase 3

Bausch + Lomb’s investigational dry eye drop combines lifitegrast, the active ingredient in Xiidra, with PFHO, the active ingredient in Miebo. The twice-daily therapy is intended to simultaneously address ocular surface inflammation and tear evaporation.

A 4-week, randomized, double-masked, parallel-group, active-controlled phase 2 trial enrolled 443 adults with dry eye disease across 6 treatment arms. These included the combination therapy, lifitegrast alone, PFHO alone, and 3 vehicle masking controls.

The study did not meet its primary endpoint of superiority to lifitegrast alone for change from baseline in total corneal fluorescein staining (tCFS) at Day 29. Although the numerical result favored the combination, the difference was not statistically significant (P=.196).

A prespecified secondary analysis at Day 15, however, demonstrated a statistically significant reduction in mean tCFS change from baseline with the combination compared with lifitegrast alone (P=.0007). Bausch + Lomb noted that Day 15 has been accepted by the FDA as a registrational primary endpoint timepoint for tCFS.

At Day 15, 41.6% of patients receiving the combination achieved an improvement of at least 3 units in tCFS, compared with 18.8% receiving lifitegrast alone and 31.6% receiving PFHO alone.

No new safety signals were identified, according to the company, and the safety findings across the treatment groups were consistent with the established profiles of Xiidra and Miebo.

Bausch + Lomb said it plans to use Day 15 as the primary endpoint timepoint when the program advances into phase 3. The company also noted that the investigational drop delivered the phase 2 findings using more than 50% less lifitegrast volume than Xiidra and at half the dosing frequency of Miebo.

“This was the first time this combination has been studied in humans, and it did exactly what a phase 2 should do: demonstrated a rapid, robust treatment effect and told us precisely when to measure it,” said Yehia Hashad, MD, executive vice president of R&D and chief medical officer at Bausch + Lomb.

Details of the Phase 3 program are expected to be announced in the coming months.

BL1332 targets ocular pain signaling

The company also reported positive phase 1b findings for BL1332, a topical TRPV1 antagonist being developed to target pathways involved in ocular pain signaling.

The study evaluated BL1332 0.30% ophthalmic solution in healthy adults using a capsaicin-induced ocular pain challenge. According to Bausch + Lomb, the trial met its primary endpoint, with BL1332 producing a statistically significant reduction in pain intensity compared with vehicle.

Five seconds after the capsaicin challenge, BL1332-treated eyes had a 5.5-point reduction in mean pain intensity compared with vehicle (P<.0001).

Exploratory analyses showed complete pain resolution in 68.2% of BL1332-treated eyes compared with none of the vehicle-treated eyes (P<.0001). No BL1332-treated eyes reported severe pain, compared with 36.4% of vehicle-treated eyes (P<.01).

Mean pain duration following the capsaicin challenge was 1.6 seconds with BL1332 versus 37.8 seconds with vehicle (P<.0001). The company reported no new safety signals.

“These results provide the first clinical evidence that targeting TRPV1 can meaningfully reduce ocular pain in humans that have not just undergone surgery,” Dr. Hashad said. “They also strengthen our confidence in the mechanism as we continue evaluating BL1332 in patients with clinically relevant pain conditions.”

BL1332 is now being evaluated in an ongoing phase 2 study involving patients with pain following photorefractive keratectomy surgery. Topline results are expected within the next few months.

Bausch + Lomb said the mechanism could ultimately have applications beyond postsurgical pain, including ocular surface pain associated with dry eye disease and other acute and chronic ocular disorders. Future development plans will depend on additional clinical findings and regulatory discussions.

• Oculis has treated the first patient in PIONEER-1, the first of 2 registrational trials evaluating Privosegtor for acute-onset optic neuritis
• The study's primary endpoint is the proportion of patients gaining at least 15 letters from baseline, with the primary analysis planned for month 3
• Privosegtor has received FDA Breakthrough Therapy and EMA PRIME designations for optic neuritis, and Oculis is also planning to study the therapy in acute MS relapses

Oculis announced that the first patient has been treated in the PIONEER-1 registrational trial evaluating Privosegtor for acute-onset optic neuritis, marking the start of the company’s late-stage clinical program for the investigational neuroprotective therapy.

PIONEER-1 is the first of 2 registrational studies in Oculis’ PIONEER program, or "Privosegtor Investigation in Optic Neuropathies Efficacy Evaluation Research." The trial is enrolling a broad population of patients with acute-onset optic neuritis, including those with and without multiple sclerosis (MS).

“Treating the first patient in PIONEER-1 at a leading center in the US is a pivotal milestone as we advance our late-stage pipeline while focusing on neuro-ophthalmology,” Riad Sherif, MD, CEO of Oculis, said in a company statement.

Dr. Sherif added that, if successful, Privosegtor could address an unmet need for neuroprotection in optic neuropathies and potentially have applications in neurological conditions, including acute MS relapses.

Privosegtor is an investigational peptoid small molecule designed to cross the blood-brain and retinal barriers. Oculis is developing the agent as a potential neuroprotective treatment for optic neuritis, with the goal of preserving neural structures and visual function following acute disease.

The primary endpoint of PIONEER-1 is the proportion of patients achieving a gain of at least 15 letters from baseline. The secondary endpoint is mean change in low-contrast visual acuity at month 3. The primary analysis will take place at month 3, with patients followed through month 12 to evaluate long-term safety and tolerability.

According to Oculis, dosing and enrollment criteria in PIONEER-1 will closely resemble those used in the phase 2 ACUITY trial. In that study, Privosegtor produced improvements in low-contrast visual acuity at month 3 that persisted through month 6, along with anatomical and biological findings that the company said were consistent with neuroprotection compared with placebo.

Those findings supported the FDA's granting of Breakthrough Therapy designation and the European Medicines Agency's granting of Priority Medicines, or PRIME, designation to Privosegtor for optic neuritis.

Oculis also received written agreement from the FDA under a Special Protocol Assessment for PIONEER-1. According to the company, the agency agreed that the trial's design and planned analysis adequately address objectives necessary to support a potential new drug application for optic neuritis, provided the study is successful and subject to review of the complete NDA data package.

Oculis said it and its partners have established a multidisciplinary network involving emergency department physicians, ophthalmologists, and neurologists to identify and enroll eligible patients. The company said the approach is intended to streamline the pathway from patient identification to treatment and account for seasonal patterns in optic neuritis enrollment.

“For decades, our approach to optic neuritis and other acute MS attacks has stopped at trying to reduce the secondary acute inflammation, while preventing axonal and secondary neuronal loss has not been accomplished,” said Mark Kupersmith, MD, professor and vice chair of translational research and chair of NORDIC at the Icahn School of Medicine at Mount Sinai in New York. He added that positive findings from PIONEER-1 could provide insights into treating optic neuropathies and measuring structural central nervous system preservation in other neurodegenerative conditions.

Beyond optic neuritis, Oculis is preparing to investigate Privosegtor in acute MS relapses. The company said it plans to submit an investigational new drug application for that indication in the fourth quarter of 2026 following pre-IND feedback from the FDA's neurology division.

• SightGlass Vision says 2 million children worldwide have now worn Dot spectacle lenses, doubling the reported number of wearers in less than a year
• In the Cathay study, Dot lenses reduced mean myopia progression by 67% and mean axial length progression by 62% after 2 years versus control among Chinese children aged 6 to 13 years
• The spectacle lenses use Diffusion Optics Technology to manage retinal contrast as an approach to slowing childhood myopia progression

SightGlass Vision announced that 2 million children worldwide have now worn its Dot spectacle lenses for myopia control, reaching the milestone less than a year after the company surpassed 1 million wearers.

According to SightGlass, the milestone reflects growing adoption of spectacle-based approaches to childhood myopia management. Dot lenses use the company’s Diffusion Optics Technology, an approach designed to manage retinal contrast while providing vision correction.

“Two million children in Dot lenses is a powerful reminder of why we do this work, and a testament to the need for this safe and effective myopia control treatment,” Andrew Sedgwick, CEO of SightGlass Vision, said in a company statement. “We’re proud that so many eye care professionals trust Dot lenses to correct their young patients’ vision today and help reduce future eye health risks.”

SightGlass Vision also highlighted recent clinical findings from its Cathay study in China. According to the company, Dot lenses slowed mean myopia progression by 67%, corresponding to 0.78 D, and mean axial length progression by 62%, or 0.40 mm, after 2 years compared with the control group among Chinese children aged 6 to 13 years.

Among children aged 6 to 10 years, the company reported that treatment with the lenses resulted in more than 1 D less myopia progression on average after 2 years.

The technology is based on research investigating the relationship between retinal contrast and eye growth. Dot lenses incorporate thousands of microscopic elements that softly scatter light before it reaches the retina, with the aim of reducing contrast while maintaining a clear central zone for vision.

“Parents are often surprised to learn how quickly myopia can progress in young children,” said Craig McArthur of Peter Ivins Eye Care in the United Kingdom. “Dot lenses fill the need for an easy and highly effective solution to offer families, and having strong clinical evidence behind that recommendation gives us greater confidence in those conversations with parents.”

SightGlass Vision has also introduced its Control the Contrast professional education campaign, which is intended to help eye care professionals understand the science underlying contrast management and its application to myopia care.

Dot lenses first became commercially available in 2021 and have since launched in Canada, China, Israel, Spain, and the United Kingdom. SightGlass Vision said additional market introductions are anticipated in 2026.

Founded in 2016, SightGlass Vision operates as a joint venture between CooperVision and Essilor International.

• NICE's draft guidance recommends against NHS funding of low-dose atropine for myopia control in children aged 3 to 14 years who meet specified progression and severity criteria
• NICE cited insufficient evidence to determine whether low-dose atropine represents value for money in this population, while noting that the recommendation does not affect private treatment
• Existing NHS treatment started before publication of the guidance would not be affected, and the recommendation remains subject to NICE's final decision

The National Institute for Health and Care Excellence (NICE) is consulting on draft guidance recommending against National Health Service (NHS) funding of low-dose atropine eye drops to slow myopia progression in children who meet specified criteria in England.

According to a post on Association of Optometrists' website, the draft recommendation applies to children aged 3 to 14 years with myopia progression of at least 0.50 D per year and myopia ranging from -0.50 D to -6.00 D. The recommendation concerns NHS funding and does not affect the use of low-dose atropine through private care.

NICE said the draft recommendation is based on uncertainty about the cost-effectiveness of low-dose atropine in this population.

“This is because there is not enough evidence to determine whether low-dose atropine eye drops are value for money in this population,” the draft guidance states.

If the recommendation is finalized, low-dose atropine would not be routinely funded by the NHS for slowing myopia progression in children who meet the criteria outlined in the guidance. However, NICE specified that the recommendation is not intended to alter NHS treatment that began before publication of the guidance.

“This recommendation is not intended to affect treatment with low-dose atropine eye drops that was started in the NHS before this guidance was published,” NICE stated. “People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published.”

The guidance remains in draft form and is subject to consultation before NICE issues its final recommendations. NICE invited stakeholders to comment on whether all relevant evidence was considered and whether its summaries of clinical effectiveness and cost-effectiveness reasonably reflect the available evidence.

The consultation closed August 19.

Following publication of the draft guidance, the Association of Optometrists (AOP) updated the atropine section of its guidance on myopia management in clinical practice to reflect the NICE recommendation. Because the recommendation is provisional, the final position could change following NICE's consideration of consultation responses and additional evidence submitted during the appraisal process.

• Patients reported approximately 58% less overall discomfort in Iheezo-treated eyes compared with fellow eyes receiving proparacaine, with statistically significant differences at all 4 assessments
• The largest differences occurred shortly after intravitreal injection, including a 1.62-point difference at 2 minutes and a 1.56-point difference at 1 hour
• The prospective contralateral-eye study included 50 patients undergoing same-day bilateral intravitreal injections, allowing each patient to serve as their own control

Harrow announced positive results from a prospective, randomized, contralateral-eye study evaluating Iheezo (chloroprocaine hydrochloride ophthalmic gel) 3% for ocular surface anesthesia in patients undergoing same-day bilateral intravitreal injections.

The single-center, investigator-initiated study included 50 adult patients, representing 100 eyes, and found statistically significant differences in patient-reported discomfort favoring Iheezo over proparacaine ophthalmic solution 0.5% at all 4 post-injection assessments.

According to Harrow, patients reported approximately 58% less discomfort overall in eyes treated with Iheezo compared with fellow eyes treated with proparacaine. Differences between the treatments were statistically significant at each measured time point (all P ≤ .048).

The largest absolute differences were observed soon after injection, when patient-reported discomfort was highest. At 2 minutes, mean discomfort scores were 1.44 with Iheezo compared with 3.06 with proparacaine, an absolute difference of 1.62 points. At 1 hour, scores were 1.26 and 2.82, respectively, representing a 1.56-point difference. Lower discomfort scores in Iheezo-treated eyes remained evident through the 24-hour assessment.

“Patient comfort is a larger part of the intravitreal injection experience than it is sometimes given credit for,” Travis Peck, MD, of Retina Consultants of Delmarva and principal investigator of the study, said in the announcement.

Dr. Peck noted that the contralateral-eye design allowed investigators to directly compare the 2 anesthesia approaches within individual patients on the same day.

“Patients consistently reported less discomfort in the Iheezo-treated eye across all time points we measured,” he said. “For retina specialists who perform a high volume of injections and care for patients who return repeatedly for treatment, these are practical and clinically relevant findings.”

The prospective study was conducted at a private retina practice. Each participant underwent same-day bilateral intravitreal injections, with 1 eye randomly assigned to receive Iheezo and the fellow eye receiving preservative-containing proparacaine ophthalmic solution 0.5%. Both eyes received pledgets soaked with lidocaine 2% before administration of the randomized study anesthetic. By comparing treatments in fellow eyes of the same patient, investigators sought to reduce between-patient variability in perceptions of discomfort.

“These results provide new clinical evidence from a real-world practice setting supporting Iheezo’s differentiated clinical profile versus commonly administered legacy ophthalmic anesthesia modalities,” said Harrow CEO Mark L. Baum.

The company said the findings could be particularly relevant to retina practices managing patients who undergo injections repeatedly over months or years.

• The FDA updated TearCare's indication to include improving meibomian gland function in adults with dry eye disease due to meibomian gland dysfunction (MGD); it is the first and only treatment with this indication.
• TearCare is designed to address MGD using targeted thermal energy to soften obstructive meibum and, when combined with manual expression, clear gland obstructions.
• The expanded indication reinforces the importance of addressing MGD as an underlying cause of dry eye disease.

The FDA expanded the indications for use for the TearCare System (Sight Sciences), making it the first and only treatment for meibomian gland dysfunction (MGD) indicated to improve meibomian gland function in patients with dry eye disease.

The updated indications for use states: "The Sight Sciences TearCare System is a thermal-activated gland expression therapy that improves meibomian gland function in adult patients with evaporative dry eye disease due to MGD, when used in conjunction with manual expression of the meibomian glands."

Meibomian gland dysfunction is a leading cause of evaporative dry eye disease, affecting millions of patients and impacting visual quality, ocular comfort, and daily vision-related activities. The updated FDA indication reinforces the importance of addressing meibomian gland dysfunction as an underlying cause of dry eye disease while providing eye care providers with a clinically meaningful endpoint focused on gland function.

"This label expansion represents a landmark moment for both the dry eye category and Sight Sciences," said Paul Badawi, cofounder and CEO of Sight Sciences. "For the first time, eye care providers and patients have a treatment indicated to improve meibomian gland function for evaporative dry eye disease due to MGD. This important milestone reflects our commitment to advancing the science of interventional dry eye disease and providing eye care providers and patients with technologies that address the underlying cause, not just symptoms."

“For chronic, progressive diseases like dry eye disease and glaucoma, meaningful treatment should ultimately be measured by what we can do to preserve or improve physiological function—not simply manage the consequences of disease,” said Neel R. Desai, MD, director of cornea, cataract, and refractive surgery at The Eye Institute of West Florida. “The recognition that TearCare improves meibomian gland function represents an important evolution in dry eye care. It validates the shift toward interventions designed to improve the function disrupted by MGD and raises the bar for what we should expect from treatment.”

The TearCare System is designed to address meibomian gland dysfunction through precisely controlled, targeted thermal energy delivered directly to the eyelids while preserving natural blinking. Its proprietary SmartLids technology maintains therapeutic heat across the meibomian glands, helping soften obstructive meibum and, when combined with clinician-directed manual expression, effectively clear gland obstructions and improve meibomian gland function.

The updated clearance not only expands TearCare's indication to include improvement of meibomian gland function but also incorporates optional debridement as part of the TearCare System, further enhancing its comprehensive approach to treating evaporative dry eye disease due to MGD.

• Lupin and Tenpoint Therapeutics have entered into a partnership, providing VISUfarma exclusive rights to commercialize Yuvezzi (carbachol and brimonidine tartrate ophthalmic solution) 2.75%/0.1% in key European markets
• Yuvezzi is the first and only approved once-daily, dual-agent eye drop for presbyopia in adults

VISUfarma, a wholly owned subsidiary of Lupin, has entered into an exclusive licensing agreement with Visus Therapeutics, a wholly owned subsidiary of Tenpoint Therapeutics, providing VISUfarma the exclusive rights to undertake regulatory activities, commercialization, marketing, promotion, distribution, and sale of Yuvezzi (carbachol and brimonidine tartrate ophthalmic solution) 2.75%/0.1% in the European Union, the United Kingdom, Switzerland, Norway, and Iceland (licensed territories).

Yuvezzi is a proprietary ophthalmic product indicated for the treatment of presbyopia in adults. Under the agreement, VISUfarma will make a strategic investment in Visus. Tenpoint and Visus, individually or collectively, will also be eligible to receive regulatory and commercial milestone payments and tiered royalties based on net sales.

“We are delighted to partner with Tenpoint Therapeutics to bring a novel ophthalmic therapy that advances our specialty care strategy,” said Vinita Gupta, CEO of Lupin. "Building on the strategic acquisition of VISUfarma, this partnership further strengthens our vision care franchise and expands our presence across key European markets. The addition of Yuvezzi underscores our commitment to broadening access to differentiated therapies, improving patient outcomes, and reinforcing our leadership in eye care across the licensed territories.”

"This exciting partnership marks an important step for Tenpoint as we continue our work to make Yuvezzi available for the millions of patients with presbyopia and eye care professionals around the world,” said Henric Bjarke, CEO of Tenpoint. "Lupin’s strong commercial operations span major European markets, and its specialty ophthalmology company VISUfarma’s longstanding presence in eye care makes them an excellent partner. We look forward to working together as we bring Yuvezzi to Europe.” 

As the first and only approved once-daily, dual-agent eye drop for presbyopia, Yuvezzi's addition to Lupin’s ophthalmology portfolio supports the company’s strategy for expanding its specialty care business through innovative therapies that address significant unmet patient needs.

Tenpoint is advancing commercialization of Yuvezzi in the United States following the product's recent FDA approval, further expanding the reach of Yuvezzi through strategic regional partnerships worldwide. In addition, Tenpoint has submitted a Marketing Authorization Application to the United Kingdom’s Medicines and Healthcare products Regulatory Agency via the agency's International Recognition Procedure. The company will continue to execute its plans for regulatory applications for Yuvezzi in other key regions worldwide.

• Eyconis announced the initiation of OVERTURE, a first-in-human phase 1b/2a clinical trial of EYC-0305 in patients with treatment-naïve wet AMD.
• In the trial, patients will receive a single intravitreal dose of EYC-0305 every 24 weeks, without traditional monthly loading doses.
• The goal of developing EYC-0305 is to provide durable disease control while reducing treatment burden without the need for surgery, an implant, or a device.

Eyconis announced the initiation of OVERTURE, a first-in-human clinical trial of EYC-0305 in patients with treatment-naïve wet AMD. EYC-0305 is designed to deliver sustained anti-VEGF therapy using the TransCon technology platform licensed from Ascendis Pharma for ophthalmology. The goal is to provide durable disease control while reducing treatment burden, with the potential to enable treatment intervals of 6 months or longer without the need for surgery, an implant, or a device.

The OVERTURE study is an open-label phase 1b/2a clinical trial designed to evaluate the safety and tolerability of intravitreal EYC-0305 across multiple dose levels. Patients with treatment-naïve wet AMD are expected to receive a single dose of EYC-0305 every 24 weeks, without traditional monthly loading doses. The study will also evaluate pharmacokinetics and measures of disease activity to inform the next stage of EYC-0305 clinical development, including the potential for durability beyond 6 months.

“Despite major advances in the treatment of exudative retinal diseases, there remains a significant unmet need for therapies that can safely and consistently extend dosing intervals while maintaining optimal disease control,” said Charles C. Wykoff, MD, PhD, Director of Research at Retina Consultants of Texas, investigator in the OVERTURE trial, and scientific advisor to Eyconis, in a press release from the company. “A markedly longer-acting biologic anti-VEGF [agent] delivered by standard intravitreal injection would be an important advance.”

The company has two main platform technologies: TIE-body, designed to directly activate the vascular stabilization receptor TIE2, and LCIDEC (Ligand Capture & Internalization into Endothelial Cells), designed to stabilize damaged vasculature while enabling the targeted removal of disease-causing proteins.

With the IPO proceeds, Ingenia plans to expedite clinical development across its broader pipeline, including IGT-303 for the treatment of chronic kidney disease (currently in phase 2a), IGT-532 for the treatment of solid tumors (advancing toward clinical trials), and preclinical candidates for glaucoma (IGT-302) and pulmonary arterial hypertension (IGT-627).

In addition, Zeiss Clinic 360 offers eye care providers the flexibility to choose the data management approach that best fits their needs. While Zeiss Forum continues to provide robust data management for practices that prefer to use local infrastructure, Zeiss Clinic 360 was created to deliver a cloud-based alternative that provides flexibility and scalability in a subscription-based model with low upfront costs followed by monthly or annual payments.

“Practices are dealing with increasing volumes of information from imaging devices, medical records, and diagnostic testing. With ZEISS CLINIC 360, our game-changing, cloud-based solution presents a truly comprehensive view of a patient, supporting a wide range of practices with actionable clinical insights and flexible configurations,” said Anuj Kalra, Head of Chronic Disease Management at Zeiss Medical Technology.

Zeiss Clinic 360 is part of the Zeiss ophthalmic workflow portfolio and is planned to become available in the United States in the fall of 2026.

• Researchers at Moorfields Eye Hospital and the University College of London (UCL) Institute of Ophthalmology have developed a collagen scaffold engineered to deliver limbal epithelial stem cells and stromal stem cells to eyes with aniridia-related keratopathy
• Aniridia-related keratopathy causes conjunctival tissue to grow over the cornea, turning the eye opaque and forming a thickening layer that gradually worsens vision
• The novel therapy led to improved vision at 12 months in nine eyes—an improvement of almost five lines of vision on a standard vision chart

A study recently published in JAMA Ophthalmology found that a breakthrough stem cell treatment for aniridia-related keratopathy (ARK) can improve patients’ vision.¹

This a first-in-human clinical trial for a previously untreatable rare genetic eye condition was conducted at Moorfields Eye Hospital and the University College of London (UCL) Institute of Ophthalmology.

Aniridia, a surface disorder affecting the limbal stem cells, is an inherited genetic eye disease due to a mutation of the PAX6 gene, resulting in profound vision loss. ARK is a progressive form of aniridia that leads to limbal stem cell deficiency, affecting one in 40,000 to 100,000 of the population. It causes conjunctival tissue to grow over the cornea, turning the eye opaque and forming a thickening layer that gradually worsens vision.

The Moorfields team developed a collagen scaffold engineered to deliver limbal epithelial stem cells and stromal stem cells to treat the affected area. In the trial one eye obtained this intervention while the fellow eye acted as a control.

The nine patients in the trial started with an average ocular surface score (OSS) of 9.4 in the treated eye, 8.4 in the untreated. (Scores of 0-5 are classified as mild, 6-10 moderate and 11-15 severe). The treated eyes improved to 5.9 after 3 months (6.7 after 12 months), while the untreated eyes were 8.0 after 12 months. The treated eyes’ ETDRS scores also improved by an average of 24 letters, or almost five lines of a standard vision chart.

“This is the first-ever optical use of a collagen scaffold containing two types of stem cells and has proved effective for a previously untreatable progressive condition leading to sight loss,” said Sajjad Ahmad, MBBS, PhD, study author and consultant ophthalmic surgeon at Moorfields Eye Hospital and professor of corneal regeneration at the UCL Institute of Ophthalmology. “We are now looking to take this forward to a larger clinical trial, with a view to this being accepted as an NHS treatment.”

This research was made possible by funding from Medical Research Council, Moorfields Eye Charity, and the NIHR Biomedical Research Centre at Moorfields Eye Hospital.

Reference

1. Kaye AE, Morgan L, Shah R, et al. Combined limbal epithelial and stromal cell transplant for aniridia-related keratopathy: a nonrandomized clinical trial. JAMA Ophthalmol. Published online July 23, 2026. doi:10.1001/jamaophthalmol.2026.2701.

• CMS establishes final payment amounts for FSYX pump and goggles effective October 1.
• The FSYX Ocular Pressure Adjusting Pump is a noninvasive therapy designed to lower IOP during sleep.
• Under HCPCS Level II code E2403, the FSYX pump will be reimbursed as a capped rental at approximately $1,352.58 per month for 1 to 3 months and $1,014.44 per month for 4 to 13 months, resulting in a total capped Medicare payment of $14,202.09 per beneficiary following 13 months of continuous use.

Balance Ophthalmics, announced that the Centers for Medicare & Medicaid Services (CMS) has established final 2026 Medicare payment amounts for the FSYX Ocular Pressure Adjusting Pump (OPAP) and associated goggles, which take effect October 1, 2026.

Under HCPCS Level II code E2403, the FSYX pump will be reimbursed as a capped rental at approximately $1,352.58 per month for the first 3 months and $1,014.44 per month for 4 to 13 months, resulting in a total capped Medicare payment of $14,202.09 per beneficiary following 13 months of continuous use. The FSYX goggles, assigned HCPCS Level II code A6610, received a final 2026 fee schedule amount of approximately $167.99 per unit.

“Final Medicare pricing is an important validation of the OPAP category and another meaningful milestone as we prepare to commercialize FSYX,” said Seph Jensen, chief executive officer of Balance Ophthalmics. “With FDA clearance, HCPCS coding and now final Medicare payment amounts in place, the infrastructure of Balance is coming together to support physician adoption and patient access. We believe this creates a strong foundation not only for the launch of FSYX, but for establishing OPAP as a meaningful new category in glaucoma care.”

FSYX (pronounced “physics”) is a prescription-only, noninvasive therapy designed to lower IOP during sleep in adults with open-angle glaucoma. The system combines pressure-modulating goggles with a pump that applies gentle negative pressure to the eyes while patients sleep. Across 12 clinical studies involving more than 600 eyes, FSYX demonstrated a 39% mean reduction in nighttime IOP with no device-related serious adverse events reported.

The wireless-enabled FSYX system also transmits objective patient usage data directly to the prescribing practice, providing clinicians with greater visibility into at-home therapy use. The system is designed to be used alongside existing glaucoma therapies, including prior surgical interventions.

Balance Ophthalmics anticipates availability of FSYX OPAP to eye care practices in Q4 2026.

• A recently published peer-reviewed article highlights the use of Biovance Ocular decellularized basement membrane (DBM) in almost 1,000 patients with neurotrophic keratitis (NK).
• The study found that corneal epithelial resolution occurred in all eyes with complete follow-up.
• The lead author believes Biovance Ocular (DefEYE) DBM products can be a first-line approach to NK when corneal sensitivity has been compromised and documented.

DefEYE announced the publication of a peer-reviewed article authored by Brandon Ayres, MD; Nicole Fram, MD; Lisa Feulner, MD, PhD; Helen Wu, MD; and Neel Desai, MD, highlighting the use of Biovance Ocular decellularized basement membrane (DBM) in almost 1,000 patients with neurotrophic keratitis (NK).

“At DefEYE, we remain committed to generating high-quality clinical evidence that helps physicians intervene earlier and preserve vision. Our goal is to provide eye care professionals with scientifically validated differentiated technologies. The recent publication, authored by leading cornea specialists, further strengthens the growing body of clinical evidence supporting serial application of decellularized basement membrane clinical management of early neurotrophic keratitis by supporting reduced corneal staining, increasing corneal sensitivity and lowering of elevated clinical biomarkers,” said Rob Sambursky, MD, chief executive officer of DefEYE.

The article, entitled “Retrospective Evaluation of Successive Biovance Decellularized Basement Membrane Tissue Grafts for the Management of Chronic Subclinical and Stage 1 Neurotrophic Keratitis,” published in Clinical Ophthalmology, demonstrated outcomes of serial placement of Biovance Ocular DBM grafts in patients with subclinical or Mackie Stage 1 NK.

“Neurotrophic keratitis is likely more prevalent than we believe. Should we conduct the appropriate corneal sensitivity testing at patient presentation of symptoms, I believe we will uncover more patients for whom we can intervene sooner, particularly with interventional approaches such as decellularized basement membrane,” said Dr. Ayres. “With corneal epithelial resolution occurring in all eyes with complete follow-up in this study, and seeing functional corneal sensitivity improvement along with high rates of osmolarity normalization and reduction in MMP-9 positivity, I believe Biovance Ocular decellularized basement membrane products can be a first-line approach to NK, so long as corneal sensitivity has been compromised and documented.”

Study highlights:

• Corneal epithelial resolution occurred in all eyes with complete follow-up.
• Functional corneal sensitivity improved in 0.7% of Brill 3, 31.6% of Brill 4, and 77.5% of Brill 5 eyes.
• Mean DBM use increased with disease severity (Brill 3: 3.70; Brill 4: 3.08; Brill 5: 4.30 grafts). Among eyes with abnormal baseline osmolarity, 70% to 82% normalized following treatment.
• MMP-9 positivity decreased across all severity groups, with 56% to 66% converting to negative, corresponding with improved ocular surface stability.

In addition to the peer-reviewed article, Dr. Ayres will present a poster entitled “Neurotrophic Keratitis Is Likely Underdiagnosed: Evidence From a Large Real-World Cohort” at the upcoming AAO Meeting, October 10 – 12, 2026, in New Orleans, LA.

• Duravyu 2.7 mg missed the primary noninferiority endpoint versus on-label aflibercept 2 mg in the full LUGANO dataset, but an ad hoc analysis excluding 9 of 211 patients (4%) showed noninferiority (nominal P = .0096)
• Duravyu 2.7 mg reduced treatment burden by 42% versus aflibercept 2 mg (nominal P < .0001); 76% of patients were supplement-free through week 32 and 54% remained supplement-free through week 56
• Among Duravyu-treated patients, 94% received zero or one supplemental injection through week 32 and 79% received zero or one supplemental injection through week 56

EyePoint announced that Duravyu (vorolanib intravitreal insert) 2.7 mg did not meet the primary endpoint of noninferiority to on-label aflibercept 2 mg in the full dataset of the phase 3 LUGANO trial in wet age-related macular degeneration (AMD), although an ad hoc analysis excluding 9 of 211 Duravyu-treated patients showed noninferiority (nominal P = .0096).

The excluded patients, representing 4% of the Duravyu group, experienced vision loss of 15 or more letters that EyePoint said was unrelated to wet AMD. No patients in the aflibercept 2 mg control arm experienced vision loss of 15 or more letters unrelated to wet AMD. The trial’s primary endpoint was noninferiority in average change from baseline in best-corrected visual acuity (BCVA) at weeks 52 and 56.

Duravyu 2.7 mg reduced treatment burden by 42% versus on-label aflibercept 2 mg, meeting superiority for this secondary endpoint (nominal P < .0001). According to EyePoint, the reduction corresponded to an average of two fewer injections through week 56, compared with a maximum possible reduction of 60%.

Among Duravyu-treated patients, 76% required no supplemental aflibercept through week 32, and 94% received zero or one supplemental injection during that period. Through week 56, 54% remained supplement-free, and 79% received zero or one supplemental injection. In a prespecified analysis of supplement-free patients, Duravyu was noninferior to on-label aflibercept for change in BCVA from baseline to the average of weeks 52 and 56 (nominal P = .0035).

At week 56, the mean difference in central subfield thickness between Duravyu and on-label aflibercept was 4 µm. Among the 54% of Duravyu-treated eyes that remained supplement-free through week 56, the difference was 3 µm compared with the aflibercept control group.

EyePoint reported no differences between groups in cataracts, elevated IOP, or intraocular inflammation and no cases of insert migration, anterior chamber opacities, free-floating drug particles, retinal vasculitis, or severe intraocular inflammation.

• CMS clarified that prior authorization disclosures must be publicly accessible without password-protected portals and must identify all medical items and services subject to prior authorization
• Lists consisting only of procedure codes do not satisfy transparency requirements; CMS recommends plain-language descriptions and standardized service categories
• CMS requires turnaround-time metrics to include units of time and directs that median turnaround times of less than 1 day be reported in hours

The Centers for Medicare & Medicaid Services (CMS) has issued updated guidance strengthening federal prior authorization transparency requirements, including new clarification on how health plans must make prior authorization policies and performance data accessible and understandable to patients and physicians.

The guidance addresses several concerns raised by the AMA after its review of 15 Medicare Advantage contracts found that required disclosures were often difficult to locate, incomplete, or presented in formats that were difficult to interpret. The review examined implementation of transparency provisions in the 2024 CMS Interoperability and Prior Authorization final rule.

CMS clarified that prior authorization information is not considered publicly accessible if it is available only through password-protected portals or cannot be reached through ordinary navigation from a payer’s public-facing website. Plans also must publicly identify all medical items and services subject to prior authorization.

The agency further stated that lists of procedure codes without plain-language descriptions do not satisfy transparency requirements. CMS recommends that payers provide a single, comprehensive list organized by uniform service categories and including CPT codes, plain-language descriptions, and a machine-readable format.

CMS also addressed data reporting. Turnaround-time metrics must include a unit of time, and median turnaround times of less than 1 day must be reported in hours rather than rounded to 0 days. CMS also recommended that payers explain data-quality issues affecting their reports.

The AMA had documented instances in which plans posted extensive lists of billing codes without plain-language explanations, placed disclosures behind physician or member portals, reported statistics that the AMA characterized as mathematically impossible, and omitted categories such as behavioral health and postacute services.

“CMS has taken an important step toward making prior authorization information more transparent and usable,” AMA President Willie Underwood III, MD, MSc, MPH, said.

The AMA is urging CMS to take additional steps, including defining prior authorization based on how the process functions regardless of terminology, linking prior authorization information to federal and state plan-comparison tools, and requiring standardized reporting templates.

• Issue 91 of Contact Lens Update focuses on practical strategies for discussing and fitting contact lenses for presbyopia.
• The issue includes data from a study of 1,064 contact lens wearers treated at 118 French eye care practices.
• A downloadable patient handout is intended to support discussions of presbyopia and available contact lens correction approaches.

The Centre for Ocular Research & Education (CORE) has published Issue 91 of Contact Lens Update, focusing on strategies to help eye care practitioners educate patients about contact lens options for presbyopia.

The issue includes an editorial by Shalu Pal, OD, FAAO, FSLS, FBCLA, that outlines practical approaches to presbyopia counseling, including proactive early education, personalized explanations of accommodative status, guidance through the contact lens fitting process, and assessment of visual satisfaction.

A feature article by Susan Gromacki, MS, FAAO, FSLS, reviews findings from a questionnaire and focus group examining perceptions of presbyopia and preferred forms of vision correction among adults aged 36 to 48 years.

The issue also includes a patient handout explaining presbyopia and different contact lens correction approaches. The downloadable resource is intended to help practitioners discuss the advantages and disadvantages of contact lens options and identify approaches that may suit individual patients’ lifestyles.

A conference highlight contributed by Marc Vincent, PhD, describes a study of 1,064 new and experienced contact lens wearers at 118 French eye care practices. Presbyopic participants were fitted with soft daily disposable or frequent-replacement multifocal contact lenses and evaluated comfort and satisfaction, handling, and quality of vision after the trial period. The study also reported continuation rates and reasons for discontinuation.

• IACLE members can directly access the WCO Alcon Dry Eye Wheel and Dry Eye Management Map through the IACLETOP learning management system.
• The updated WCO Alcon Dry Eye Wheel incorporates recommendations from the TFOS DEWS III report and organizes dry eye care around mitigation, measurement, and management.
• Both educational resources are available in Arabic, Chinese, French, and Spanish, with additional languages planned.

The World Council of Optometry (WCO) and Alcon have partnered with the International Association of Contact Lens Educators (IACLE) to expand access to digital educational resources from the WCO-Alcon dry eye initiative for university instructors, educators, and students.

IACLE members can now directly access the initiative’s WCO Alcon Dry Eye Wheel and Dry Eye Management Map through the IACLE Teaching Online Platform (IACLETOP) learning management system. IACLE has more than 1,100 members in 86 countries representing more than 600 academic institutions.

The recently updated WCO Alcon Dry Eye Wheel incorporates recommendations from the Tear Film & Ocular Surface Society Dry Eye Workshop III (TFOS DEWS III) report. The interactive resource is intended to help eye care professionals approach dry eye care through 3 steps: mitigation, measurement, and management.

The complementary Dry Eye Management Map is an online interactive resource designed to help eye care professionals, educators, and students navigate evidence-based dry eye disease management. Both resources are available in several languages, including Arabic, Chinese, French, and Spanish, with additional languages planned.

According to the organizations, the collaboration is intended to make dry eye educational tools more readily available to instructors and students and to support consistent approaches to dry eye disease education and patient care.

• Two trials at the University of Cologne are evaluating antisense oligonucleotide eye drops targeting IRS-1 in patients with aniridia-associated keratopathy and high-risk corneal transplantation
• The Olisens-Aniridia study is expected to enroll 20 participants for 12 weeks of treatment, while Olisens-Precon is expected to enroll 10 participants for a 4-week treatment period

A European research consortium has begun recruiting patients for 2 clinical trials evaluating gene-silencing eye drops as a potential treatment for abnormal corneal blood vessel growth associated with rare ocular diseases, according to Restore Vision, a Horizon Europe-funded research project coordinated by the University of Galway, Ireland.¹

The studies, underway at the University Hospital Cologne in Germany, will evaluate antisense oligonucleotide eye drops targeting insulin receptor substrate 1 (IRS-1) in patients with aniridia-associated keratopathy and patients undergoing or who have undergone high-risk corneal transplantation. The trials mark the first use of the treatment in patients with these rare diseases, according to the EU-funded Restore Vision consortium.

The investigational eye drops, known as Olisens, are designed to inhibit expression of IRS-1, a protein involved in signaling pathways associated with the growth of blood and lymphatic vessels into the cornea. Corneal neovascularization can compromise corneal transparency and visual function and, among patients receiving corneal transplants, substantially increase the risk of graft rejection.

“Currently there is no adequate targeted treatment option for corneal neovascularization in clinical routine,” said Mert Mestanoglu, MD, study physician in the Department of Ophthalmology at the University of Cologne. He added that treatment options for aniridia-associated keratopathy are particularly limited because of the disease's complexity and rarity.

The Olisens-Aniridia and Olisens-Precon studies are recruiting at the Department of Ophthalmology at the University of Cologne. The consortium describes the studies as phase 2 trials evaluating a new indication for a product that already has marketing authorization.

Olisens-Aniridia is expected to enroll 20 participants and will include a 12-week treatment period. The Olisens-Precon study is expected to enroll 10 participants and will have a 4-week treatment period. Recruitment for both studies is planned over 12 months.

Eligible participants include patients with aniridia-associated keratopathy and patients scheduled for or who have previously undergone high-risk corneal transplantation. Restore Vision lists the indications under investigation as aniridia-associated keratopathy and corneal neovascularization resulting from herpetic keratopathy.

Aniridia is a rare genetic disorder affecting approximately 1 in 100,000 people, according to the consortium. Beyond the characteristic absence or incomplete development of the iris, patients can develop progressive ocular surface disease. In aniridia-associated keratopathy, abnormal vessels can grow across the normally avascular cornea, contributing to loss of transparency and deterioration of vision.

Rather than delivering conventional antiangiogenic therapy, the Olisens approach uses antisense oligonucleotides to interfere with expression of the IRS-1 target. By reducing the relevant molecular signal, investigators hope to limit the pathologic blood and lymphatic vessel growth that can damage the cornea.

The topical route could also be important for diseases of the cornea and ocular surface because the medication can be administered directly to the eye without an intraocular procedure. Restore Vision reported that the eye drops have received orphan drug designation. The Cologne studies will provide early clinical evidence on the safety and potential efficacy of the approach in the targeted rare-disease populations.

For high-risk corneal transplantation, controlling neovascularization is particularly relevant because vascularization of the recipient cornea increases the likelihood of immune-mediated graft rejection. In aniridia-associated keratopathy, meanwhile, clinicians face limited options for addressing progressive corneal surface deterioration and neovascularization.

The trials are part of Restore Vision, a Horizon Europe-funded program coordinated by the University of Galway in Ireland. The consortium includes 10 research institutions, small and medium-sized enterprises, and patient organizations working on therapies for rare corneal and ocular surface diseases.

The broader program is developing treatments for 7 rare eye diseases estimated to affect approximately 500,000 people across Europe.

Reference

1. Restore Vision. European consortium launches first human trial of gene-silencing eye drops for rare eye diseases. Restore Vision. Published August 11, 2026. Accessed August 14, 2026. https://restorevision-project.eu/european-consortium-launches-first-human-trial-of-gene-silencing-eye-drops-for-rare-eye-diseases/.

• Anti-VEGF treatment for DME was associated with reduced PDR risk primarily during the first 4 weeks following an injection, with the protective effect declining rapidly thereafter
• Severe baseline NPDR, younger age, and type 1 diabetes were among the strongest predictors of progression despite anti-VEGF treatment
• Continued dilated retinal surveillance remains important for patients receiving anti-VEGF therapy because repeated injections do not eliminate the risk of progression to PDR

Real-world data from more than 2800 eyes suggest that the protective effect of anti-VEGF therapy against progression to proliferative diabetic retinopathy (PDR) is greatest soon after treatment and declines rapidly after approximately 4 weeks.¹

The findings, published in BMJ Open Ophthalmology, also indicate that patients with diabetic macular edema (DME) may continue to progress to PDR despite receiving repeated anti-VEGF injections, underscoring the importance of continued diabetic retinopathy surveillance during treatment.

Abraham Olvera-Barrios, MD, and colleagues conducted the retrospective multicenter study using routine clinical data from 27 UK National Health Service centers. The investigators sought to determine how repeated anti-VEGF exposure for DME modifies the risk of progression from nonproliferative diabetic retinopathy (NPDR) to PDR in clinical practice.

The primary analysis included 2858 eyes from 2858 patients with NPDR and DME treated with anti-VEGF therapy. Investigators modeled repeated injections as time-dependent exposures using Cox regression and a weighted cumulative exposure approach. Models were adjusted for baseline diabetic retinopathy severity, age, sex, ethnicity, diabetes type, and deprivation.

During a median follow-up of 1.2 years, 209 eyes in the anti-VEGF-treated cohort developed PDR. Patients received a median of 11 intravitreal injections during follow-up. At baseline, 67% of treated eyes received ranibizumab, 31% received aflibercept, and 2% received bevacizumab.

The weighted cumulative exposure model indicated that current and recent anti-VEGF injections had the strongest protective association with PDR risk. That effect declined rapidly as the interval from the most recent injection increased and reached approximately zero at 4 weeks.

More remote injections did not appear to substantially affect the current risk of PDR, according to the investigators. The finding suggests that the retinopathy-modifying effects of repeated anti-VEGF treatment should not necessarily be considered persistent or cumulative over extended periods.

The investigators noted that decreasing treatment frequency to less than monthly or discontinuing therapy would therefore be expected to increase PDR risk relative to continued monthly treatment, particularly among patients already at high risk of progression. 

Anti-VEGF exposure did not eliminate the importance of established risk factors for progression. Compared with eyes with mild NPDR at baseline, those with moderate NPDR had nearly twice the hazard of developing PDR (HR, 1.99; 95% CI, 1.13-3.51), whereas severe NPDR was associated with more than a 4-fold increase in hazard (HR, 4.63; 95% CI, 2.55-8.41).

Diabetes type and age also were associated with progression. Patients with type 1 diabetes had approximately twice the PDR hazard of those with type 2 diabetes (HR, 2.08; 95% CI, 1.35-3.21). Conversely, every 5-year increase in age was associated with a 9% reduction in PDR hazard.

Among patients with severe NPDR and DME, intraretinal microvascular abnormalities were associated with an increased risk of progression compared with dot-blot hemorrhages in 4 quadrants (HR, 2.55; 95% CI, 1.12-5.79).

Overall, the cumulative incidence rate of PDR among anti-VEGF-treated eyes with DME was 4.45 per 100 person-years. By 3 years, approximately 4% of treated eyes with mild NPDR had progressed to PDR compared with 25% of treated eyes with severe NPDR. Younger patients also demonstrated higher progression rates; by year 3, PDR had developed in approximately 22% of treated patients younger than 55 years compared with 9% of those aged 65 years or older.

The results have implications for patients managed in injection-focused clinical pathways, in which peripheral retinal examination may not occur at every visit.

According to the investigators, repeated anti-VEGF therapy for DME should not be considered a substitute for surveillance for PDR. They recommended that dilated assessment of NPDR in patients receiving anti-VEGF therapy should not extend beyond established monitoring intervals based on retinopathy severity—approximately every 12 months for mild NPDR, 6 months for moderate NPDR, and 3 to 4 months for severe NPDR—with patient age also considered when determining follow-up.

The authors acknowledged limitations inherent to the retrospective electronic health record analysis, including potential inaccuracies and missing clinical information. The dataset also lacked systemic factors such as glycemic control and blood pressure, which could confound PDR risk. In addition, data were extracted through December 2018, and the investigators did not evaluate PDR risk according to individual anti-VEGF agents because treatment switching was common.

Reference

1. Olvera-Barrios A, Lilaonitkul W, Heeren TFC, et al. Impact of anti-VEGF treatment for diabetic macular oedema on progression to proliferative diabetic retinopathy: data-driven insights from a multicentre study. BMJ Open Ophthalmol. 2025;10(1):e002234. doi:10.1136/bmjophth-2025-002234.

• The first patient has undergone subretinal implantation of DSP-3077 in a phase 1/2a study for non-syndromic retinitis pigmentosa
• The 12-participant study will primarily evaluate the safety and tolerability of 2 dose levels while also assessing engraftment, potential therapeutic response, and delivery-device performance
• DSP-3077 consists of iPS cell-derived multilayered retinal sheets containing photoreceptor precursors 

Sumitomo Pharma America announced that the first patient has undergone subretinal implantation in a phase 1/2a study evaluating DSP-3077, an investigational regenerative cell therapy for non-syndromic retinitis pigmentosa (RP).

DSP-3077 uses allogeneic retinal sheets derived from induced pluripotent stem (iPS) cells and is designed to provide retinal tissue containing photoreceptor precursors to patients with RP.

The phase 1/2a open-label, single-arm, uncontrolled, dose-escalation study (NCT06891885) is evaluating 2 dose levels of DSP-3077 administered through a single, uniocular subretinal implantation in adults with RP. The study's primary objective is to assess the safety and tolerability of the 2 dose levels. Additional objectives include evaluating safety, engraftment, potential therapeutic response, and the performance of the device used to deliver DSP-3077.

Investigators plan to enroll 12 participants across 3 cohorts, with 4 participants in each cohort. Cohorts will be defined according to visual acuity criteria and DSP-3077 dose level.

“We are encouraged by the potential that iPS cells may hold for treating degenerative, debilitating conditions like RP that currently have few therapeutic options, and this first patient treated is a notable milestone for our company,” said Tsutomu Nakagawa, PhD, president and CEO of Sumitomo Pharma America.

Dr. Nakagawa said treatment of the first study participant represents an important step toward understanding the potential of DSP-3077 and future iPS cell-based therapies for patients with RP.

The technology underlying DSP-3077 is based on a self-organizing cell culture technique known as the "SFEBq method," which is used to generate 3-dimensional neural tissues and organoids from pluripotent stem cells.

According to Sumitomo, the technology was originally developed by Yoshiki Sasai, MD, PhD, and his research group at RIKEN in Japan. Sumitomo Chemical subsequently conducted joint research with RIKEN to further develop the technology, and Sumitomo Pharma later developed a manufacturing process for producing iPS cell-derived retinal sheets.

DSP-3077 is based on a 3-dimensional retinal organoid that is processed into multilayered retinal sheets designed to retain retinal tissue structure and contain abundant photoreceptor precursors. In the phase 1/2a study, these sheets are implanted into the subretinal space.

Sumitomo Pharma America and Sumitomo Pharma are developing DSP-3077 in collaboration with Racthera and S-Racmo as part of ongoing work to advance retinal regenerative therapies.

The FDA granted DSP-3077 Orphan Drug Designation for the treatment of RP in March 2026.

• Prevent Blindness says proposed changes to Head Start could weaken standards governing how children receive vision screenings and increase variation among programs
• Current Head Start requirements call for evidence-based vision screenings within 45 days of a child’s first day in the program, along with referrals when follow-up care is needed
• Prevent Blindness is urging Congress to pass the bipartisan EDVI Act, which would provide federal support for state and community pediatric vision-care systems

Prevent Blindness has raised concerns about proposed changes to the Head Start Program that the organization says could weaken standards for vision screening and increase inconsistencies in children’s access to early detection and follow-up eye care.

In a statement, the nonprofit said it is reviewing the proposed rule from the Trump administration that would make changes to Head Start, a federal program providing education, health, and other services to children from birth through age 5 from families with lower incomes.

Under current Head Start requirements, programs must conduct evidence-based vision screenings within 45 days of a child’s first day in the program and refer children requiring follow-up vision care to appropriate providers for additional treatment and family services. According to Prevent Blindness, the underlying federal statute would continue to require Head Start programs to conduct vision screenings under the proposed rule. However, the organization said the proposal would relax standards governing how screenings are performed, potentially allowing programs to use approaches that do not follow evidence-based guidelines.

The proposed rule also directs Early Head Start programs to coordinate with state and local entities to provide health services, a change Prevent Blindness characterized as part of a broader shift toward a more state-based Head Start model.

The organization emphasized the importance of identifying vision problems early in childhood, when untreated disorders can interfere with learning and development. Prevent Blindness cited research indicating that approximately 21.4% of Head Start preschoolers have a vision disorder. It also noted that, according to the Office of Head Start, vision-related medical diagnoses among participating children are second in frequency only to asthma.

“In addition to other fundamental changes to the Head Start program, loosening requirements around how and when vision screenings are conducted risks creating even greater inconsistency and could result in children receiving screenings that do not follow evidence-informed guidelines,” said Donna Fishman, executive director of the National Center for Children’s Vision and Eye Health at Prevent Blindness.

She added that children participating in Head Start should have access to timely vision screening and appropriate follow-up care so that problems can be identified and treated before contributing to permanent vision loss or difficulties with early learning and school readiness.

Jeff Todd, president and CEO of Prevent Blindness, said the organization and its National Center for Children’s Vision and Eye Health would continue advocating for access to effective vision screening and follow-up care regardless of a child’s location or family economic circumstances.

Prevent Blindness also plans to submit comments on the proposed rule before the October 6 deadline and is calling on Congress to pass the bipartisan Early Detection of Vision Impairments for Children Act, or EDVI Act. The legislation would provide federal grants intended to help states and communities develop and strengthen systems of care for children’s vision. It would also support a national technical assistance center focused on promoting evidence-based practices.

The full Prevent Blindness statement can be found here.

• Annexon added a Month 24 dual primary endpoint to ARCHER II while retaining the phase 3 trial’s Month 15 primary endpoint
• An independent DMC is expected to assess the Month 15 primary endpoint in the fourth quarter of 2026, with sub-study results potentially following in the first quarter of 2027

Annexon has added a 'Month 24' dual primary endpoint to its phase 3 ARCHER II trial evaluating vonaprument in patients with geographic atrophy (GA), while retaining the study’s existing 'Month 15' primary endpoint. The company also announced the launch of an open-label extension study designed to evaluate the long-term safety and potential benefit of vonaprument in patients with GA.

According to Annexon, the dual primary endpoint strategy gives ARCHER II the opportunity to demonstrate protection against vision loss at either Month 15 or Month 24 as independent efficacy timepoints. The company expects an independent Data Monitoring Committee (DMC) assessment of the Month 15 primary endpoint in the fourth quarter of 2026.

“Our objective is to maximize the best-in-class potential of vonaprument to preserve visual acuity for millions of patients at risk of irreversible vision loss,” said Douglas Love, president and CEO of Annexon.

Mr. Love noted that ARCHER II was already designed to remain masked through Month 24, allowing the additional endpoint to be incorporated without changing study operations. He added that the company remains on schedule for the Month 15 data milestone in the fourth quarter of 2026, with Month 24 results to follow as a separate assessment.

ARCHER II is an ongoing global, double-masked phase 3 trial. Annexon reported that all eligible patients have received at least 12 months of treatment and that masked event accrual remains in line with projections. The company also reported a discontinuation rate of less than 10% and treatment compliance exceeding 95%.

After patients complete Month 24, they will have the option to receive monthly vonaprument in the open-label extension study.

Under the revised analysis plan, the independent DMC will assess the overall study’s primary endpoint at Month 15. If the DMC determines that ARCHER II has met the Month 15 primary endpoint, the company plans to proceed with analyses of the trial’s 2 sub-studies, with those results expected in the first quarter of 2027.

Alternatively, the DMC may recommend continuing the study to the Month 24 primary endpoint analysis. Annexon expects completion of ARCHER II, including the Month 24 analyses, in the third quarter of 2027.

Vonaprument, formerly known as ANX007, is an investigational antigen-binding fragment designed to selectively inhibit C1q, the initiating molecule of the classical complement pathway. The intravitreally administered therapy is being developed as a neuroprotective approach intended to preserve photoreceptor cells and retinal function while leaving the lectin and alternative complement pathways intact.

The investigational therapy has received Fast Track designation from the US Food and Drug Administration and Priority Medicines designation from the European Medicines Agency (EMA) for GA. Annexon said vonaprument was also selected for the EMA’s Product Development Coordinator pilot, which launched in July 2025 to assist PRIME-designated programs with regulatory interactions and development activities.

• Alfasigma has agreed to acquire 100% of Nordic Pharma and its subsidiaries from Sever Life Sciences
• The transaction includes Nordic Pharma’s ophthalmology portfolio and expands Alfasigma’s commercial presence across Europe, Canada, and Japan
• Nordic Pharma is the maker of the Lacrifill Canalicular Gel for dry eye disease

Alfasigma has entered into a share purchase agreement with Sever Life Sciences B.V. to acquire 100% of Nordic Group BV, known as Nordic Pharma, and its subsidiaries, the companies announced.

Financial terms of the deal were not disclosed.

The transaction will add Nordic Pharma’s specialty pharmaceutical portfolio, including products in ophthalmology, women’s health, critical care, and rheumatology, to Alfasigma’s operations. In its ophthalmology portfolio, Nordic Pharma is the maker of the Lacrifill Canalicular Gel, a CE-marked and FDA-cleared medical device for lacrimal occlusion. It is a transparent and sterile gel made of cross-linked hyaluronic acid, intended to block tear drainage by occlusion of the canalicular system. Lacrifill is indicated for use, for up to 6 months, in patients experiencing dry eye symptoms.

It is also the maker of Biolon and Biolon Prime ophthalmic viscoelastic devices (OVDs).

Privately owned Nordic Pharma has direct operations in Europe, Canada, and Japan. The acquisition will expand Alfasigma’s commercial footprint with direct operations in 18 European countries while adding commercial platforms in Canada and Japan.

In rheumatology, the transaction adds Nordic Pharma’s established business led by the Nordimet methotrexate franchise. Alfasigma currently markets the Jyseleca franchise, and the company said the combination will strengthen its position in the therapeutic area. The acquisition will also bring approximately 265 Nordic Pharma employees to Alfasigma.

“Alfasigma is the right partner for Nordic Pharma as we enter our next phase of growth,” said Charlotte Phelps, CEO of Nordic Group B.V. “We look forward to combining our experience to support patients.”

The planned acquisition is consistent with Alfasigma’s merger-and-acquisition strategy as the company expands its international specialty and rare disease operations. Recent transactions include its acquisition of Jyseleca in inflammatory diseases and a licensing agreement with GSK for linerixibat, an investigational treatment for cholestatic pruritus associated with primary biliary cholangitis in adults.

Completion of the Nordic Pharma transaction remains subject to customary closing conditions, including required regulatory clearances.

• NovelMed is advancing the Alternative Pathway inhibitor NM5072 toward clinical development for geographic atrophy and other complement-associated retinal diseases
• A single intravitreal dose reduced CNV lesion area and measures of fibrosis and hemorrhage in a rhesus monkey model, while rabbit studies provided additional efficacy data.

NovelMed Therapeutics is advancing NM5072 as an ocular development candidate for geographic atrophy (GA) and other complement-associated retinal diseases, supported by preclinical efficacy findings and phase 1 clinical safety data.

NM5072 is designed to selectively inhibit the complement "Alternative Pathway" (AP), an inflammatory pathway implicated in several retinal diseases. NovelMed said it plans to conduct ocular toxicology studies before moving the candidate into clinical evaluation for GA and potentially other ophthalmic indications.

“NM5072 combines phase 1 clinical experience, selective Alternative Pathway inhibition, and compelling primate data showing activity across CNV, fibrosis, and hemorrhage,” said Rekha Bansal, PhD, chief executive officer of NovelMed Therapeutics. “These findings support our vision of developing a durable therapy for multiple complement-driven retinal diseases, including geographic atrophy.”

In a laser-induced choroidal neovascularization (CNV) study in rhesus monkeys, a single intravitreal dose of NM5072 reduced CNV lesion area and improved measures of retinal fibrosis and hemorrhage, according to NovelMed. The company reported no evidence of drug-related ocular toxicity in the study.

NM5072 also reduced CNV area and volume in rabbit studies, providing efficacy findings across 2 preclinical species.

Pharmacokinetic data may also support extended dosing intervals. In a single-dose intravitreal rabbit study, NM5072 had an estimated ocular half-life of approximately 7 days. NovelMed said translational modeling projects an ocular half-life of approximately 21 days in humans.

Based on that modeling, the company estimates NM5072 could remain above concentrations required for AP inhibition for approximately 140 days, or more than 4 months. If confirmed clinically, the pharmacokinetic profile could potentially support dosing intervals exceeding 4 months.

NovelMed is positioning NM5072 as a potential treatment across a range of retinal disorders in which complement activation may contribute to disease progression.

NovelMed is also pursuing ophthalmology partnerships for NM5072, including potential out-licensing, co-development, regional licensing, commercialization, and other strategic collaborations. The company's broader complement portfolio includes NM8074, a clinical-stage antibody targeting complement Factor Bb. NovelMed views that program as additional clinical validation of its Alternative Pathway platform.

• The first patient has been dosed in the phase 2 DREAM study evaluating oral ART27.13 in patients with glaucoma or ocular hypertension
• ART27.13 is a peripherally selective synthetic cannabinoid receptor agonist being investigated for its ability to reduce IOP while limiting central nervous system effects
• Artelo Biosciences expects initial results from the DREAM study later in 2026

Artelo Biosciences announced that the first patient has been dosed in the phase 2 DREAM study evaluating ART27.13, an orally administered synthetic cannabinoid, in patients with glaucoma or ocular hypertension.

The DREAM study—Determining the Role of synthetic cannabinoids in Eye pressure And tolerability Measurements—is evaluating whether ART27.13 can safely reduce IOP. The investigational therapy is a peripherally selective synthetic cannabinoid receptor agonist designed to activate cannabinoid receptors in ocular tissues while limiting activity in the central nervous system.

According to Artelo Biosciences, the peripheral selectivity of ART27.13 could potentially reduce the psychotropic adverse effects that have complicated previous investigations of cannabinoids for ocular indications.

“There remains an urgent need for safe, well-tolerated, and effective new treatments for glaucoma that can provide additional options to reduce intraocular pressure and preserve vision,” said Augusto Azuara-Blanco, PhD, clinical professor of ophthalmology at Queen’s University Belfast and honorary consultant ophthalmologist at Belfast Health and Social Care Trust. “The potential role of peripherally selective cannabinoids in ocular health is an exciting and largely unexplored area. This study is expected to provide important insights into whether ART27.13, which is designed to act outside the central nervous system, can safely lower intraocular pressure without psychotropic side effects.”

Dr. Azuara-Blanco is leading the DREAM study, which is sponsored by Belfast Health and Social Care Trust and conducted by the Northern Ireland Clinical Trials Unit. Funding is being provided by Glaucoma UK and the HSC R&D Division.

The DREAM study will investigate whether targeting cannabinoid receptors with an orally administered, peripherally selective agent could provide another approach to IOP management.

“ART27.13’s peripherally selective design may overcome the challenges of CNS adverse effects which has been an issue when other oral or topical cannabinoids have been explored in this indication,” said Gregory D. Gorgas, president and CEO of Artelo Biosciences.

The company expects to report initial results from the DREAM study later in 2026.

• The FDA has accepted Belite Bio’s NDA for tinlarebant in Stargardt disease type 1 and granted Priority Review, with a PDUFA date of February 12, 2027
• The phase 3 DRAGON trial showed a 35.7% reduction in the growth rate of atrophic retinal lesions with tinlarebant compared with placebo
• If approved, tinlarebant would become the first FDA-approved treatment for Stargardt disease type 1

The FDA has accepted Belite Bio’s new drug application (NDA) for tinlarebant for the treatment of Stargardt disease type 1 (STGD1) and granted the application Priority Review, the company announced.

The agency has set a Prescription Drug User Fee Act (PDUFA) target action date of February 12, 2027. If approved, tinlarebant would become the first FDA-approved treatment for STGD1.

The NDA is supported by results from the phase 3 DRAGON trial, which evaluated tinlarebant in patients with STGD1. According to the company, treatment with tinlarebant resulted in a statistically significant 35.7% reduction in the growth rate of atrophic retinal lesions compared with placebo. Lesion growth was assessed as definitely decreased autofluorescence (DDAF) using fundus autofluorescence imaging.

Belite Bio reported that tinlarebant has been generally well tolerated in clinical trials, with adverse effects consistent with its mechanism of action.

“The acceptance of our NDA with Priority Review designation underscores the immediate need among the Stargardt disease community for an approved treatment option, and we believe it reinforces the quality and depth of the data that we’ve generated,” said Tom Lin, MD, chairman and CEO of Belite Bio.

Dr. Lin added that the company plans to work with the FDA during the review while continuing preparations for a potential commercial launch.

STGD1 is a rare inherited retinal disorder associated with mutations in the ABCA4 gene. The condition typically causes progressive retinal degeneration and irreversible vision loss, often beginning early in life. Belite Bio estimates that approximately 53,000 people in the United States are affected.

There are currently no FDA-approved pharmacologic treatments for STGD1, leaving patients reliant primarily on supportive measures, including low-vision aids.

Tinlarebant is an oral, once-daily investigational therapy being developed for degenerative retinal diseases. With Priority Review, the FDA aims to take action on applications for therapies that could offer significant improvements in the treatment, diagnosis, or prevention of serious conditions.

• Omega Ophthalmics closed a $7 million Series A financing round to support development, manufacturing scale-up, and clinical planning for the Gemini Refractive Capsule
• The implant technology is designed to provide a platform for IOL implantation while preserving the capsular bag and potentially allowing future lens exchange
• Omega has scheduled an FDA pre-submission meeting to obtain feedback on its regulatory pathway and clinical development plans ahead of anticipated US clinical studies

Omega Ophthalmics has closed a $7 million Series A financing round as the company advances development of its Gemini Refractive Capsule, an implant technology designed for use in cataract surgery. Omega also announced that it has scheduled a pre-submission meeting with the FDA to discuss the proposed regulatory pathway and clinical development plans for the Gemini technology.

Omega said the financing was led by a group of "strategically aligned ultra-high-net-worth investors." Proceeds from the financing are expected to support continued product development, intellectual property activities, regulatory work, manufacturing scale-up, and clinical planning as Omega prepares for future FDA studies and potential commercialization.

“We are grateful for the support and confidence of our investors who recognize the potential of the Gemini Refractive Capsule to fundamentally improve cataract surgery,” Rick Ifland, chief executive officer of Omega Ophthalmics, said in the announcement.

The Gemini Refractive Capsule is designed to provide a stable platform for IOL implantation while preserving the capsular bag. According to Omega, the technology is intended to improve long-term refractive stability while maintaining the potential for future lens exchange and incorporation of next-generation ophthalmic technologies.

“The Gemini Refractive Capsule has the potential to address longstanding challenges associated with conventional IOL implantation by providing surgeons with greater flexibility while creating opportunities to improve long-term patient outcomes,” said John Berdahl, MD, of Vance Thompson Vision. “If successful, this technology could significantly expand what's possible in refractive cataract surgery.”

The upcoming FDA pre-submission meeting will provide Omega with an opportunity to receive agency feedback on its proposed regulatory pathway and plans for clinical development.

• BostonSight and L V Prasad Eye Institute have initiated an IRB-approved prospective, multisite study examining mental health outcomes in new PROSE treatment and BostonSight Scleral patients
• The study could help clarify whether improvements associated with specialty lens treatment correspond with measurable changes in mental health among patients with corneal and ocular surface disease

BostonSight has initiated a prospective, multisite clinical trial evaluating the potential effects of PROSE treatment and scleral lens use on mental health among patients with corneal and ocular surface disease.

The Institutional Review Board-approved study is being conducted in partnership with L V Prasad Eye Institute (LVPEI) in Hyderabad, India. The organizations have a longstanding collaboration, with LVPEI providing PROSE treatment and distributing BostonSight Scleral lenses in India and the surrounding region.

Investigators will enroll new patients receiving PROSE treatment or being fitted with BostonSight Scleral lenses and assess changes in mental health alongside ocular surface symptoms and visual function.

“IRB approval is an important milestone that confirms this study meets established ethical and regulatory standards. We are excited to move forward with this important study to evaluate quantifiable mental health outcomes associated with these specialty lenses,” Prashant Garg, MD, executive chair of LVPEI, said in the announcement.

The study is designed to investigate whether measurable changes in mental health correlate with specialty lens treatment. Investigators will use the Patient Health Questionnaire-9 (PHQ-9) to assess mental health outcomes. Ocular surface symptoms will be evaluated using the Ocular Surface Disease Index (OSDI), while visual functioning will be measured with the 25-item National Eye Institute Visual Function Questionnaire (VFQ-25). Researchers will examine how changes in mental health relate to scores on these vision- and ocular surface-focused measures.

PROSE treatment is a customized, nonsurgical treatment for patients with corneal and ocular surface disease that combines medical management with individually customized scleral lenses, which are FDA-cleared medical devices. BostonSight Scleral is a commercially available lens used for patients with mild to moderate corneal and ocular surface disease.

• PracticeAmerica has launched a physician-to-physician marketplace intended to help independent practice owners identify potential physician buyers
• Founder Joel Hayden, OD, based the model partly on his experience purchasing an optometry practice through seller financing early in his career

PracticeAmerica has launched a doctor-to-doctor practice transition marketplace aimed at providing independent physicians with an alternative path for selling their practices, according to an announcement from the company.

PracticeAmerica is designed to connect physicians seeking to sell their practices directly with qualified physician buyers. The company describes itself as a transaction facilitator rather than a broker and said it does not involve private equity firms in its transaction model. Under the platform's fee structure, sellers pay a 5% fee when a transaction closes, with no upfront costs. Buyers are not charged a fee, according to the company.

The marketplace was founded by Joel Hayden, OD, a Massachusetts-based optometrist and 1992 graduate of the New England College of Optometry who has more than 30 years of experience in independent practice ownership.

Dr. Hayden said the concept grew partly from his own experience entering private practice. In 1993, shortly after graduating, he purchased an optometry practice through a seller-financed transaction developed by his father, Jack Hayden, after traditional bank financing was unavailable. He went on to spend approximately 30 years as an independent practice owner before selling his practice to a private equity-backed organization in 2023. Those experiences on both the buying and selling sides of practice ownership helped shape the new marketplace, according to Dr. Hayden.

"The deal that launched my career was seller-financed because the banks said no," Hayden said in the announcement. "PracticeAmerica is built on that same idea, that doctors taking care of doctors is the most powerful deal structure in medicine."

PracticeAmerica is targeting solo and small-group practices in optometry and several other health care specialties, including dentistry, primary care, podiatry, dermatology, and chiropractic. The company said the marketplace may be particularly applicable to practices that do not meet the acquisition criteria of private equity groups, as well as larger practices in which associates are interested in purchasing ownership directly.

"There are tens of thousands of independent practices owned by physicians over 55 who have no structured exit plan," Dr. Hayden said. "We built a marketplace specifically for that gap, and we built it doctor to doctor."

The platform provides practice valuation tools and educational materials related to seller financing, along with a promissory note template. It also offers what the company calls a Deal Health Report system, which is intended to help parties monitor a transaction during the repayment period.

• Oculis has agreed to acquire Accure Therapeutics’ worldwide development and commercial rights to Privosegtor, terminating the companies’ existing license agreement 
• The broader transaction, which also includes the preclinical candidate ACT-02, provides for $3.8 million in upfront cash and up to 2.05 million Oculis ordinary shares
• Privosegtor is advancing in the PIONEER-1 registrational trial for optic neuritis, while Oculis plans an IND submission in the fourth quarter of 2026 to pursue development in acute multiple sclerosis relapses

Oculis and Accure Therapeutics have entered into an asset purchase agreement under which Oculis will acquire Accure’s worldwide development and commercial rights to Privosegtor (ACT-01), a neuroprotective candidate currently in registrational development for optic neuritis.

The transaction will terminate Oculis’ existing license agreement with Accure, including associated milestone and royalty obligations for successful indications. Oculis said the acquisition is intended to give the company greater economic participation in Privosegtor’s potential future success while providing additional flexibility as it develops the asset and evaluates expansion into other indications.

Under the agreement, Oculis will acquire Accure’s rights to Privosegtor at the first closing. In a separate closing, Oculis is also expected to acquire ACT-02, an early-stage preclinical neurology drug candidate. The two closings are subject to separate conditions precedent, with the ACT-02 transaction contingent on completion of the ACT-01 acquisition. The Privosegtor closing is expected no later than February 28, 2027, while the ACT-02 closing is expected no later than March 31, 2027.

Total consideration for the transactions includes an upfront cash payment of $3.8 million (CHF 3.1 million), payable to Accure at the first closing, as well as up to 2.05 million Oculis ordinary shares. Oculis also expects to assume existing license agreements with academic institutions for each asset. Those agreements include low single-digit percentage royalty obligations and provisions preserving the institutions’ rights to use the assets for academic and noncommercial purposes, as required under Spanish law.

The agreement has been approved by the Oculis board of directors and by Accure’s board and shareholders.

“Acquiring Accure’s rights to Privosegtor is an important strategic milestone for Oculis,” Riad Sherif, MD, CEO of Oculis, said in a statement. “By terminating our legacy license agreement with Accure, we can secure global commercial rights to this unique, long-term asset at significantly reduced royalties as we build a leadership position in neuro-ophthalmology.”

Dr. Sherif pointed to the ongoing PIONEER-1 registrational trial in optic neuritis and the company’s planned investigational new drug application for acute multiple sclerosis relapse as key upcoming development milestones.

Privosegtor is a peptoid small molecule designed to cross the blood-brain and retinal barriers. Oculis is developing the candidate as a potential neuroprotective therapy for optic neuritis, with possible applications across other neuro-ophthalmic and neuro-axonal diseases.

Following results from the phase 2 ACUITY trial, Oculis initiated the PIONEER clinical development program, which comprises 3 pivotal trials intended to support registration of Privosegtor in optic neuropathies.

PIONEER-1, the first registrational trial in the program, is evaluating Privosegtor in patients following acute onset of optic neuritis. The study includes patients both with and without multiple sclerosis, and Oculis reported that clinical site activation is progressing as planned.

The company has also received positive pre-IND feedback from the FDA regarding a regulatory pathway for Privosegtor in acute multiple sclerosis relapses. Oculis plans to submit an IND for that indication in the fourth quarter of 2026.

• Ocumension Therapeutics has submitted an NDA in China for NCX 470 to lower IOP in patients with open-angle glaucoma or ocular hypertension
• The application is supported by the phase 3 Mont Blanc and Denali trials and uses the same clinical dossier prepared for the US NDA submission
• NCX 470 is now under regulatory consideration in the United States and China, while phase 3 development to support a potential Japanese filing is underway

Nicox announced that its exclusive licensee in China, Ocumension Therapeutics, has submitted a new drug application (NDA) for NCX 470 to China’s Center for Drug Evaluation of the National Medical Products Administration.The application seeks approval of NCX 470 for lowering IOP in patients with open-angle glaucoma or ocular hypertension.

NCX 470 is an investigational nitric oxide-donating bimatoprost eye drop designed to lower IOP through the combined activity of nitric oxide and the prostaglandin analog bimatoprost.

According to Nicox, the Chinese NDA incorporates data from the phase 3 Mont Blanc and Denali trials. The Denali study included clinical sites in China, enabling the development program to meet clinical requirements for a regulatory application in the country. The submission uses the same clinical dossier recently submitted to the FDA in the United States, the company said.

“Nicox and Ocumension have been successfully collaborating since 2018 when we signed the first of multiple licensing deals between the two companies,” Gavin Spencer, chief executive officer of Nicox, said in a statement. “NDAs for NCX 470 have now been submitted in two major territories, the United States and China, and phase 3 trials to support a regulatory submission in Japan have been underway since summer 2025."

NCX 470 incorporates Nicox’s nitric oxide-donating technology and bimatoprost in a single molecule. It is designed to release both bimatoprost and nitric oxide in the eye, targeting IOP through 2 pathways.

Nitric oxide promotes aqueous humor drainage through activation of soluble guanylate cyclase and provides a mechanism of action distinct from that of prostaglandin analogs.

The Mont Blanc and Denali phase 3 trials were designed to provide the safety and efficacy evidence required to support regulatory submissions in the United States and China. According to Nicox, both studies met the efficacy endpoints required to support the applications.

The China filing follows a recent US NDA submission for NCX 470 by Nicox partner Kowa. Nicox said it expects a US regulatory decision in summer 2027 based on a standard 12-month review period, with a US commercial launch anticipated in the second half of 2027.

There is no fixed review period for pharmaceutical approvals in China, although Nicox said approvals are frequently granted within 12 to 18 months of submission. The company expects a potential Chinese approval to follow a US approval.

Development is also underway in Japan, where a phase 3 clinical program intended to support a future regulatory submission began in summer 2025.

Ocumension holds rights to develop and commercialize NCX 470 in China, Korea, and Southeast Asian markets. The company has paid Nicox €18 million in license fees and contributed 50% of the costs of the Denali trial. Under the licensing arrangement, Nicox is eligible for tiered royalties ranging from 6% to 12% on NCX 470 sales by Ocumension.

• The Contact Lens Institute has enlisted Olympic figure skating medalist Nancy Kerrigan to promote The EASY Way contact lens wear and care initiative
• The program centers on 3 behaviors covering hand and lens hygiene, replacement schedules and adherence to guidance from eye care professionals

The Contact Lens Institute (CLI) has named Olympic figure skating medalist Nancy Kerrigan as the face of a new promotional campaign supporting The EASY Way, the organization’s healthy contact lens wear and care initiative.

Ms. Kerrigan, a member of the United States Figure Skating Hall of Fame and a longtime vision advocate, appears in a new video addressing the eye care community and drawing parallels between learning the fundamentals of skating and establishing healthy contact lens habits.

“A lot of skating success comes from mastering fundamentals early on and sticking with them over time. That requires coaches who can break down the practices into simple actions,” Ms. Kerrigan said in the video. “That also applies to your contact lens patients, especially for health and comfortable wear and care.”

The EASY Way—an acronym for Eyes, Awareness, Safety and You—was developed to provide clinicians and patients with straightforward guidance for contact lens care. According to CLI, the initiative has been adopted by eye care practices in the United States, Canada and other countries during the past 6 years.

The program includes patient education tips, infographics and digital resources that eye care practices can incorporate into conversations about contact lens hygiene and adherence. CLI makes the materials available at no cost through its website.

At the center of The EASY Way are 3 recommendations: Think Clean, Remember Fresher is Better, and Trust Your Eye Doctor.

“Think Clean” emphasizes washing and drying hands before touching contact lenses or the eyes. Patients who use reusable lenses should clean and disinfect them after removal and maintain their lens cases as directed. The guidance also stresses keeping lenses and cases away from water because of the potential for exposure to harmful microorganisms.

“Remember Fresher is Better” focuses on adherence to prescribed lens replacement schedules. Daily disposable lenses should be discarded after a single use, while patients using reusable lenses should use fresh solution for disinfection and storage. CLI also recommends replacing contact lens cases at least every 3 months.

The final recommendation, “Trust Your Eye Doctor,” encourages patients to follow instructions from their eye care professionals and contact the practice when questions or concerns arise.

The Kerrigan video joins a series of recorded messages from optometrists and opticians supporting the initiative. CLI said the videos are available through the organization’s YouTube channel, while The EASY Way educational materials can be accessed through ContactLensInstitute.org.

• WaveFront Dynamics has integrated its WaveDȳn technologies with Bausch + Lomb and WAVE Eye Care scleral lens options
• The collaborations aim to expand clinicians’ choices for designing scleral lenses intended to address higher-order aberrations in patients with complex visual needs
• The WaveDȳn Vision Analyzer and WaveDȳn Advantage service combine wavefront measurements with customized optic design to support a more data-driven scleral lens fitting process

WaveFront Dynamics (WDI) announced new integrations with Bausch + Lomb and WAVE Eye Care that expand the scleral lens options available to clinicians using the company’s WaveDȳn Vision Analyzer and WaveDȳn Advantage optic design service.

Through the collaborations, eye care professionals using the WaveDȳn technologies will have access to Bausch + Lomb’s Zenlens Chroma HOA as well as additional scleral lens options from WAVE Eye Care. The integrations are intended to allow clinicians to pair wavefront-based diagnostic information and custom optic design with different scleral lens platforms according to individual patient needs.

“Today’s clinicians want both precision and flexibility,” Dan Neal, PhD, founder and CEO of WaveFront Dynamics, said in the announcement. “These collaborations represent an important step forward in empowering eye care professionals with advanced wavefront analysis while preserving their ability to choose the scleral lens technology they believe is best for each patient.”

The integrations focus in part on patients with complex corneal conditions and higher-order aberrations (HOAs), for whom conventional refractive correction may not fully address visual symptoms.

Patients wearing scleral lenses can continue to experience glare, halos, and blurred vision when residual HOAs remain after correction of lower-order refractive errors. The WaveDȳn Vision Analyzer is designed to measure the eye’s optical aberrations, while the WaveDȳn Advantage service uses those measurements to develop customized optics intended to address both lower- and higher-order aberrations.

Nathan Schramm, OD, of Insight Vision Costa Mesa, said the additional lens choices could give clinicians greater flexibility when applying the diagnostic information obtained through wavefront analysis.

“As a clinician focused on complex corneal cases, the diagnostic depth of the WaveDȳn Vision Analyzer has genuinely changed how I approach scleral lens selection,” Schramm said. “With expanded lens options now available through these collaborations, I have everything I need in one ecosystem to deliver truly personalized care for my patients who require scleral lenses.”

Bausch + Lomb said the integration broadens clinicians’ ability to use the WaveDȳn platform with its Zenlens Chroma HOA lenses.

“The diagnostic information these technologies provide is important to the fitting process and offers more options for designing HOA-correcting scleral lenses for patients,” said Yang Yang, president of Global Vision Care at Bausch + Lomb.

WAVE Eye Care is also expanding its relationship with WaveFront Dynamics to bring HOA-correction capabilities to its WAVE ScleraLens designs.

“Our EyePrint Prosthetics customers have seen firsthand what WaveFront Dynamics HOA-correction technology can do for their patients, and we are thrilled to bring that same capability to our WAVE ScleraLens designs,” said Brian Purdy, vice president of sales and commercial development at WAVE Eye Care.

According to the companies, the integrations may also support coordination among optometrists and ophthalmologists involved in managing patients with complex visual needs by providing additional diagnostic information and treatment-planning options.

WaveFront Dynamics said the expanded ecosystem is designed to give clinicians greater choice in scleral lens platforms while incorporating wavefront-guided measurements into the fitting and customization process.

• An analysis of more than 4.6 million ophthalmic clinical letters found that 95.3% were less readable than recommended for patient-facing information
• Readability worsened between 2013 and 2025, with Flesch Reading Ease scores declining by an average of 0.64 points annually
• Only 2.25% of letters were classified as being addressed directly to patients, highlighting an opportunity to make ophthalmic correspondence more accessible and patient-centered

Clinical letters sent following ophthalmology appointments may be considerably more difficult for patients to understand than recommended, according to a large-scale analysis of more than 4.6 million letters.¹

Investigators found that 95.3% of ophthalmic clinical letters were less readable than recommended for patient-facing materials. Moreover, readability declined over the 12-year study period, suggesting that clinical correspondence has become increasingly complex despite efforts to promote patient-centered communication.

The findings were published in BMJ Health & Care Informatics by Ariel Yuhan Ong and colleagues from University College London Institute of Ophthalmology, Moorfields Eye Hospital NHS Foundation Trust, Oxford Eye Hospital, and collaborating institutions.

Effective communication between clinicians and patients can affect engagement with care, treatment adherence, and clinical outcomes. However, the investigators noted that the extent to which routine clinical correspondence meets recommended readability standards has not been well quantified. To examine the issue at scale, researchers analyzed more than 4.6 million outpatient clinic letters written for 804,986 patients at Moorfields Eye Hospital NHS Foundation Trust in the United Kingdom between 2013 and 2025. The letters represented 17 ophthalmic subspecialty services.

The researchers assessed the correspondence using established measures of readability, including Flesch Reading Ease (FRE), the SMOG Index, and Automated Readability Index. They also evaluated more complex linguistic characteristics, including lexical density and type-token ratio. FRE served as the study's primary outcome. The investigators additionally examined differences among ophthalmic subspecialties and changes in readability over time. Rule-based measures were used to determine whether letters were addressed directly to patients.

Across the study population, the median FRE score was 51.1, with an interquartile range of 41.9 to 58.5. The researchers characterized this as approximately a college-level reading difficulty and substantially more complex than recommended for patient-facing health information.

Overall, 95.3% of letters fell outside recommended readability levels. Similar patterns emerged with the other readability measures included in the analysis. Readability also differed significantly among ophthalmic subspecialties (P<.001), whereas patient sociodemographic characteristics such as age and ethnicity showed limited associations with readability.

The findings indicate that communication complexity was not confined to an individual ophthalmic service or particular patient population but represented a broader pattern across clinical correspondence.

Rather than improving during the 12-year period, the readability of ophthalmic letters declined. FRE scores decreased by an average of 0.64 points per year (P<.001), indicating progressively more difficult text. The rate of change varied among subspecialties. Neuro-ophthalmology showed one of the largest declines, at 1.24 FRE points per year (P<.001), whereas some services, including optometry, demonstrated no statistically significant change.

The researchers also examined the extent to which correspondence appeared to speak directly to patients. Use of second-person terminology was uncommon, with a median of 0 second-person terms per 100 words and an interquartile range of 0 to 1.1. Only 2.25% of letters overall were classified as being addressed directly to patients. There was, however, evidence of gradual change. The likelihood that a letter was addressed directly to a patient increased annually, although the overall proportion remained low.

The authors suggested that their findings could provide an empirical foundation for local quality-improvement efforts aimed at making correspondence easier for patients to understand. The analytical framework could also be applied beyond ophthalmology to evaluate clinical communication in other specialties.

Reference

1. Ong AY, Kiire CA, Wagner SK, Nguyen Q, Thomas PBM, Keane PA. How well do we write for patients? Longitudinal analysis of the readability and complexity of 4.6 million ophthalmic clinical letters. BMJ Health Care Inform. 2026;33(1):e102086. doi:10.1136/bmjhci-2026-102086

• Harrow has agreed to acquire Tyrvaya from Viatris for $30 million upfront and as much as $70 million in additional net sales-based milestone payments
• The nasal spray adds a drop-free, complementary mechanism of action to a Harrow dry eye portfolio anchored by Vevye
• Harrow expects the transaction to close in the second half of 2026

Harrow has entered into a definitive agreement to acquire Tyrvaya (varenicline solution) nasal spray 0.03 mg from Viatris, expanding the company’s portfolio of treatments for dry eye disease.

Under the agreement, Harrow will pay $30 million in cash at closing, with up to an additional $70 million in contingent payments tied to Tyrvaya net sales. The transaction, which could total up to $100 million, is expected to close in the second half of 2026, subject to customary closing conditions. Harrow said it expects to fund the upfront payment with cash on hand.

Tyrvaya is a cholinergic agonist indicated for the treatment of the signs and symptoms of dry eye disease. The prescription nasal spray is approved in the United States, China, and Taiwan, with marketing authorization applications pending in additional markets.

The acquisition adds another mechanism of action to Harrow’s dry eye portfolio, which includes Vevye. Whereas Vevye is intended to address inflammation associated with dry eye disease, Tyrvaya is administered intranasally and stimulates tear production. Tyrvaya's nasal administration also provides an alternative for patients who have difficulty administering or tolerating topical ophthalmic medications. According to its prescribing information, Tyrvaya has no listed contraindications, warnings, or precautions. Sneezing is its most commonly reported adverse reaction.

“This acquisition is about Harrow’s commitment to offer the most comprehensive set of tools to help U.S. ophthalmologists and optometrists manage their patients’ dry eye disease,” said Mark L. Baum, chief executive officer of Harrow.

Mr. Baum said Tyrvaya could be prescribed either separately from or alongside Vevye, giving clinicians additional flexibility in selecting therapies based on individual patient needs. Harrow also highlighted Tyrvaya as an option for contact lens wearers because the treatment does not require ocular administration or removal of contact lenses before dosing.

“While Vevye remains the cornerstone of our dry eye franchise, Tyrvaya strengthens our foundation by expanding the number of patients and physicians we can serve through a complementary mechanism of action,” Mr.  Baum said.

In addition to Vevye and Tyrvaya, the company’s portfolio includes FreshKote Preservative Free, an over-the-counter lubricant eye drop for temporary relief of dry eye symptoms, and Flarex, a corticosteroid indicated for corticosteroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe.

In October 2021, Oyster Point Pharma received FDA approval for Tyrvaya the treatment of the signs and symptoms of dry eye disease. The approval marked the first and only nasal spray approved for the treatment of dry eye disease. In November 2022, Viatris announced a deal to acquire Oyster Point Pharma and establish it own eye care division. 

• ForSight Robotics has now performed fully robotic-assisted cataract surgery in 26 patients using the Jasper Robotic Surgical Platform, with the company reporting no conversions to manual surgery
• Patients received routine cataract anesthesia consisting of topical anesthesia alone or mild sedation and were discharged the same day, supporting the platform’s compatibility with standard outpatient workflows
• The first-in-human experience is part of the company’s development program as it advances toward additional clinical studies and regulatory submissions

ForSight Robotics has completed an additional 14 fully robotic-assisted cataract surgeries using its Jasper Robotic Surgical Platform, bringing the company’s first-in-human clinical experience to 26 patients.

According to the company, all 26 procedures were completed robotically without conversion to manual surgery. Patients received standard cataract anesthesia protocols, consisting of either topical anesthesia alone or mild sedation, and were discharged the same day. The latest procedures build on ForSight Robotics’ previously announced first-in-human experience and are intended to evaluate how robotic-assisted cataract surgery can be incorporated into routine clinical workflows.

“Our first clinical milestone established that fully robotic-assisted cataract surgery was possible. This latest clinical experience demonstrates something even more important: that robotic cataract surgery can integrate naturally into the way cataract surgery is performed every day,” said Joseph Nathan, MD, MSc, co-founder and CEO of ForSight Robotics.

The procedures were performed as part of the company’s ongoing first-in-human clinical study by Alexey Rapoport, MD.

Robert T. Ang, MD, senior consultant and head of the Cornea and Refractive Surgery Services at the Asian Eye Institute, is serving as principal investigator. 

“Patients underwent surgery using the same anesthesia approaches we use every day, either topical anesthesia alone or mild sedation, and were discharged the same day following standard postoperative care,” Dr. Ang said. “The robotic platform complemented, rather than disrupted, the normal clinical workflow while providing exceptional precision, stability, and control.”

Jasper is designed to enable a surgeon to perform the complete cataract procedure through telemanipulation. According to ForSight Robotics, the system incorporates bimanual robotic manipulation, high-definition 3-dimensional visualization, real-time eye tracking, motion scaling, tremor elimination, and computer vision technology.

The surgeon remains in control of the platform throughout the procedure, according to the company.

The additional cases represent a step in ForSight Robotics’ development program as it moves toward further clinical studies and regulatory submissions. The company said the results provide evidence that its robotic approach can operate within established cataract surgery practices. ForSight said it is also positioning the platform as a potential foundation for incorporating artificial intelligence-enabled capabilities into ophthalmic surgery.

“We believe robotic platforms will become the foundation for the next generation of intelligent surgery,” Dr. Nathan said. “By integrating seamlessly into today’s clinical practice, we are building the platform that will enable the future evolution of AI-enabled surgical capabilities in the operating room.”

• Norlase is transitioning to a direct sales and support model in Germany
• The company appointed Wolfgang Dalhoff as senior sales manager, Germany, to lead the effort
• The move aims to strengthen the company’s ability to respond quickly to clinical needs and deliver consistent, hands-on support

Norlase announced it is transitioning to a direct sales and support model in Germany and appointed Wolfgang Dalhoff as senior sales manager, Germany, to lead the effort. The company said the move reflects a broader strategy of building closer, local relationships with retina and glaucoma specialists who rely on its technology by providing a direct line for service, training, and clinical support. Establishing direct commercial operations in Germany reportedly strengthens the company’s ability to respond quickly to clinical needs and deliver consistent, hands-on support.

“Going direct in Germany is a natural next step in our growth across Europe,” said Oliver Hvidt, CEO and cofounder of Norlase.

According to a press release, Mr. Dalhoff brings more than 25 years of experience in technical sales and clinical application support across ophthalmology and optical technology, including prior roles at Ellex Deutschland, where he supported the clinical use of therapeutic laser technologies such as YAG, selective laser trabeculoplasty, and retinal laser systems, and, most recently, at Teleon Surgical.

• US News & World Report ranked Bascom Palmer Eye Institute the nation’s No. 1 ophthalmology program for 2026–2027
• This marks the 25th time the institution has earned the top spot since the rankings began in 1990
• The US News & World Report Best Hospitals rankings are based on data from nearly 5,000 medical centers and survey responses from more than 30,000 physicians

Bascom Palmer Eye Institute of the University of Miami Health System has been ranked as the nation’s best in ophthalmology by US News & World Report. According to a press release, this year marks the 25th time that Bascom Palmer has received the No. 1 ranking since the publication began surveying US physicians for its annual “Best Hospitals” rankings in 1990.

“The dedicated team at Bascom Palmer takes pride in upholding our long-standing commitment to enhancing vision, preventing blindness, and expanding expertise in ophthalmology,” said Eduardo C. Alfonso, MD, a professor of ophthalmology who served as the director of Bascom Palmer and chair of ophthalmology from 2007 to August 2, 2026.

“Bascom Palmer’s rise to national and international prominence speaks to a deep commitment to excellence in clinical care, vision research, and medical education,” said Pradeep Y. Ramulu, MD, MHS, PhD, who became Bascom Palmer’s director and chair of the University of Miami Department of Ophthalmology on August 3, 2026.

The US News & World Report rankings are based on data from nearly 5,000 medical centers and survey responses from more than 30,000 physicians, according to the press release. The 2026–2027 Best Hospital rankings are accessible at https://health.usnews.com/best-hospitals/rankings.

• Tarsus Pharmaceuticals has entered into a definitive agreement to acquire Alkeus Pharmaceuticals, adding phase 3 candidate gildeuretinol (ALK-001) to Tarsus’ retina portfolio
• The therapy for Stargardt disease is being evaluated in the ongoing phase 3 NORTHSTAR trial, with topline results anticipated in the second half of 2029
• The acquisition includes approximately $450 million in upfront consideration, up to $350 million in milestone payments upon potential regulatory approval and first commercial sale, and low single-digit tiered descending royalties as a percentage of gildeuretinol net sales

Tarsus Pharmaceuticals has entered into a definitive agreement to acquire Alkeus Pharmaceuticals, a privately held biotechnology company focused on retinal diseases that is developing gildeuretinol (ALK-001), an investigational once-daily oral therapy for Stargardt disease. The molecular entity is designed to reduce the accumulation of toxic dimers while preserving the normal visual cycle.

Under terms of the agreement, Tarsus will pay approximately $450 million upfront, consisting of $270 million in cash and $180 million in Tarsus common stock. The deal also includes milestone payments of up to $350 million upon potential regulatory approval and first commercial sale, and low single-digit tiered descending royalties as a percentage of gildeuretinol net sales. The Tarsus common stock to be issued to the Alkeus stockholders at closing of the acquisition will reportedly be priced at $61.38 per share.

Tarsus expects the pending acquisition to expand the company’s presence in retina, complement the capabilities established through the acquisition of iRenix Medical, and add a differentiated phase 3 program potentially addressing Stargardt disease.

“We believe gildeuretinol has the potential to be a transformational medicine for Stargardt disease and complements the retina capabilities we are already building through IRX-101,” said Bobby Azamian, MD, PhD, chief executive officer and chairman of Tarsus.

According to a company press release, the clinical program to date has evaluated ALK-001 across all stages of Stargardt disease. Together, the TEASE-1 and TEASE-2 studies reportedly informed the design of NORTHSTAR, the ongoing phase 3 trial expected to enroll approximately 230 patients. Per Tarsus, the primary endpoint will measure the rate of retinal atrophic lesion growth over 24 months, and the secondary endpoint will assess a key aspect of visual function, change in low light visual acuity. The trial was agreed to by the US FDA and the European Medicines Agency, and topline data are expected in the second half of 2029, Tarsus stated.

According to Tarsus, the pending transaction with Alkeus has been approved by the boards of directors of both companies and the stockholders of Alkeus and is expected to close in 2026.

The deal comes just a month after Tarsus announced it is acquiring iRenix Medical and its investigational ocular antiseptic IRX-101, a stable aqueous chlorine dioxide solution being developed to reduce postprocedural pain and corneal toxicity in patients receiving intravitreal therapy.

• Staar Surgical has appointed Warren Foust as president, CEO, and a member of the board of directors after he served as interim co-CEO and president and COO
• Deborah Andrews will become executive vice president while continuing as chief financial officer 

Staar Surgical has appointed Warren Foust as president and chief executive officer and a member of its board of directors, effective August 4, 2026. Mr. Foust succeeds from his role as interim co-CEO, president and chief operating officer, positions he had held since February 2026 and March 2025, respectively. He joined Staar in April 2023.

As part of the leadership transition, Deborah Andrews will become executive vice president while continuing to serve as the company's chief financial officer. Ms. Andrews had shared interim co-CEO responsibilities with Mr. Foust since February 2026.

"After a rigorous global search, it is clear that Warren is the right leader to take Staar forward," said Neal C. Bradsher, chair of Staar's board of directors. "He brings exceptional judgment, operational discipline, and a clear focus on change and innovation. His genuine connection to our mission and people, along with his vision for the surgeons and patients we serve, position him to deliver sustainable, long-term value for shareholders."

In accepting the appointment, Mr. Foust highlighted Staar's position in the refractive surgery market and the company's long-term growth strategy.

"Staar is defining the future of refractive surgery—leading the industry shift from corneal tissue ablation to preservation," Mr. Foust said, citing the company's installed base of more than 4 million EVO implantable collamer lenses, operations in 85 countries, and three decades of clinical experience.

He also pointed to favorable market dynamics, noting that the prevalence of myopia is expected to increase substantially over the coming decades, creating additional demand for refractive correction technologies.

Mr. Foust said Staar recently completed "the strongest first half in our company's history," with year-over-year revenue growth, improving profitability, and continued market share gains. He highlighted sequential growth in China, attributing performance to increased adoption of the EVO+ lens, an improving product mix, and higher average selling prices rather than inventory build.

The appointment comes about 7 months after the proposed merger agreement between Alcon and Staar Surgical was terminated. At the time, Staar announced that it did not receive the required stockholder approval to complete the proposed merger. 

• Vantage Biosciences has completed enrollment in the phase 2 SeeClear trial evaluating oral AOC3 inhibitor oruvestat for moderate-to-severe NPDR, with topline data expected in Q4 2027
• Oruvestat is being developed as a noninvasive, oral therapy intended to target inflammation and neurovascular dysfunction early in diabetic retinopathy
• The global, placebo-controlled study is being conducted at 26 sites across the United States, Australia, and Southeast Asia

Vantage Biosciences has completed patient enrollment in its phase 2 SeeClear (VX01-DR-201) clinical trial evaluating oruvestat (VX-01), an investigational oral therapy for non-proliferative diabetic retinopathy (NPDR).

The randomized, double-masked, placebo-controlled study has reached its recruitment target across participating sites in the United States, Australia, and Southeast Asia. With enrollment complete, all participants have entered the 52-week treatment and follow-up phase. The company expects topline results in the fourth quarter of 2027.

Oruvestat is an orally administered inhibitor of amine oxidase copper containing 3 (AOC3), an enzyme implicated in the inflammatory and neurovascular processes associated with diabetic retinopathy. By targeting upstream disease biology, the investigational therapy is intended to slow or halt disease progression and potentially improve retinopathy severity before patients require invasive treatment.

"Closing enrollment on plan across three global regions is a credit to our investigators, site teams and the patients who chose to participate in this exciting research," said Charmaine O'Neill, vice president of clinical operations at Vantage Biosciences. "Our focus now shifts to the quality of execution through the 52-week treatment period."

The SeeClear trial is enrolling patients with moderate-to-severe NPDR and is registered on ClinicalTrials.gov under identifier NCT06770933. Participants are randomized to receive either oruvestat or placebo for 52 weeks. 

• University of Iowa research established the preclinical proof of concept supporting a first-in-human gene therapy study for BBS10-associated retinal degeneration
• Three pediatric patients have received the investigational therapy through the United Kingdom's Specials program at St. Helier Hospital in London

Research conducted at the University of Iowa has helped establish the scientific foundation for a first-in-human gene therapy study targeting retinal degeneration caused by mutations in the BBS10 gene, with the first three pediatric patients recently treated in the United Kingdom.

The investigational therapy is designed to address one of the genetic causes of Bardet-Biedl syndrome (BBS), a rare inherited disorder that affects multiple organ systems and leads to progressive vision loss beginning in childhood.

The clinical milestone follows years of preclinical research led by Arlene V. Drack, MD, professor of Ophthalmology and Visual Sciences and Pediatrics at the University of Iowa Carver College of Medicine. Dr. Drack and colleagues demonstrated in proof-of-concept studies that gene replacement therapy could delay retinal degeneration and activate dormant retinal cone cells in a BBS10 mouse model.

That research was supported through philanthropic gifts and funding from InVision2020, Fighting Blindness Canada, the Bardet Biedl Syndrome Association, and the departmental Keech Professorship.

The therapy's development also builds on decades of genetic research by Val C. Sheffield, MD, PhD, professor of Pediatrics and Ophthalmology and Visual Sciences at the University of Iowa Carver College of Medicine. Dr. Sheffield identified many of the genes associated with Bardet-Biedl syndrome and developed the BBS10 mouse colony that served as a key research platform for advancing the therapeutic program.

"This milestone represents years of collaborative research focused on developing a potential treatment for children and families affected by this devastating disease," Dr. Drack said in a University article. "We're grateful to the patients, families, philanthropic supporters, research partners, and colleagues, and the lab team including Sajag Bhattarai and post-doctoral scholar Ying Hsu, PhD, whose commitment made it possible to reach this important first step in clinical translation."

The University of Iowa's preclinical findings established the scientific rationale for continued development of the therapy. London-based biotechnology company MeiraGTx subsequently partnered to develop a clinical-grade gene therapy vector for human use. The resulting vector underwent additional evaluation in both London and Iowa City before entering clinical testing.

The first-in-human study is being conducted through the United Kingdom's Specials program at St. Helier Hospital in London. Three pediatric patients have received the investigational subretinal gene therapy, with procedures performed by retinal surgeon Neruban Kumaran. The study is led by Michel Michaelides.

Following treatment, participants are traveling to Iowa for specialized ophthalmic examinations and functional vision testing intended to provide additional information on the therapy's safety and potential biological effects. The current investigation is designed primarily to assess the safety and feasibility of the investigational gene therapy. Researchers noted that additional studies will be required to determine the treatment's long-term safety and efficacy.

• A Swedish nationwide cohort study found GLP-1 receptor agonist users had a higher relative risk of anterior ischemic optic neuropathy than SGLT-2 inhibitor users, but the absolute risk remained very low
• At 1 year, AION occurred in 0.04% of GLP-1 RA users versus 0.02% of SGLT-2 inhibitor users, representing an absolute risk difference of just 0.02%

A large nationwide cohort study from Sweden found that glucagon-like peptide-1 receptor agonist (GLP-1 RA) use was associated with a higher relative risk of anterior ischemic optic neuropathy (AION), which predominantly consists of nonarteritic anterior ischemic optic neuropathy (NAION), compared with sodium-glucose cotransporter-2 (SGLT-2) inhibitors.¹ However, investigators emphasized that the absolute risk remained very low and that much of the observed association may be explained by differences in underlying diabetes severity rather than the medications themselves.

The findings, published in Annals of Internal Medicine, add to the growing body of evidence examining the potential relationship between GLP-1 RAs and ischemic optic neuropathy following reports that raised concerns about a possible safety signal.

Researchers from Karolinska Institutet and collaborating institutions conducted a nationwide, register-based cohort study using Swedish health data collected between 2013 and 2024. The investigators compared 107,518 adults with type 2 diabetes who initiated GLP-1 RA therapy with 185,898 patients who initiated SGLT-2 inhibitors, using propensity score weighting to balance baseline characteristics between groups.

Over a median follow-up of approximately 1.6 years among GLP-1 RA users and 1.5 years among SGLT-2 inhibitor users, AION occurred in 62 GLP-1 RA users and 64 SGLT-2 inhibitor users. At 1 year, the cumulative risk was 0.04% among GLP-1 RA users compared with 0.02% among SGLT-2 inhibitor users, corresponding to an adjusted risk ratio of 1.93. At 5 years, cumulative risks were 0.12% and 0.07%, respectively, with an adjusted risk ratio of 1.69.

Despite the elevated relative risk, the absolute risk differences were small—0.02% at 1 year and 0.05% at 5 years. Importantly, analyses restricted to patients already receiving metformin at baseline, intended to better account for diabetes severity, substantially attenuated the association. In these analyses, the relative risk estimates were no longer statistically significant, suggesting that residual confounding may explain at least part of the observed increase in risk.

The authors noted several limitations, including the small number of AION events, the potential for unmeasured confounding, and limited generalizability to patients using GLP-1 RAs for obesity without diabetes.

The Swedish findings were published alongside a separate U.S. target trial emulation that also reported a modest increase in ischemic optic neuropathy among GLP-1 RA users while emphasizing the rarity of the event and the potential influence of confounding factors. Together, the studies suggest that although clinicians should remain aware of the possible association, the overall risk appears to be low and should be weighed against the established cardiovascular and metabolic benefits of GLP-1 receptor agonists.

Reference

1. Ludvigsson JF, Pasternak B, et al. Glucagon-like peptide-1 receptor agonists and risk for anterior ischemic optic neuropathy: a nationwide cohort study. Ann Intern Med. Published online 2026. doi:10.7326/ANNALS-25-02096.

• Opus Genetics completed enrollment in its registrational phase 3 trial of OPGx-LCA5 for LCA5-associated inherited retinal disease
• The FDA-designed study uses a self-controlled run-in period and is intended to support a future Biologics License Application
• Dosing is expected to begin in the fourth quarter of 2026, with topline data anticipated by the end of 2027

Opus Genetics has completed patient enrollment in its registrational phase 3 clinical trial evaluating OPGx-LCA5, an investigational gene therapy for patients with LCA5-associated inherited retinal disease.

The company announced that the final patient has been enrolled in the study, which is intended to support a future Biologics License Application with the FDA. If approved, OPGx-LCA5 could become the first therapy available for patients with LCA5-associated inherited retinal disease.

The enrollment milestone follows the FDA's acceptance of the program into its Rare Disease Evidence Principles (RDEP) program in May 2026. According to the company, the phase 3 study was designed in collaboration with the agency to address the challenges of conducting registrational trials in ultra-rare diseases.

"Achieving full enrollment in our registrational phase 3 trial is a significant milestone for the OPGx-LCA5 program and reflects the dedication of participating patients and families, our clinical investigators, and our team," said George Magrath, MD, chief executive officer of Opus Genetics. "With enrollment now complete, we remain on track to initiate dosing in the fourth quarter of 2026, report topline data by the end of 2027, and continue advancing OPGx-LCA5 to bring the first potential treatment to patients with LCA5-associated inherited retinal disease."

The registrational study is evaluating the safety and efficacy of a one-time subretinal administration of OPGx-LCA5 in patients with genetically confirmed LCA5-associated inherited retinal disease. In line with discussions held under the FDA's RDEP program, the trial incorporates an evidence-generation strategy tailored to an ultra-rare disease population, including a 6-month run-in period during which participants serve as their own controls before receiving treatment.

Patients are currently completing the run-in phase, with dosing expected to begin in the fourth quarter of 2026. Opus Genetics anticipates reporting topline efficacy and safety results by the end of 2027.

OPGx-LCA5 has received multiple FDA regulatory designations, including Rare Pediatric Disease, Orphan Drug, and Regenerative Medicine Advanced Therapy status. The therapy's inclusion in the RDEP program is intended to facilitate the development of evidence supporting regulatory review in rare diseases where conventional trial designs may not be feasible.

• MDConsult AI has commercially launched its AI-powered pre-consultation platform after a beta rollout that included 320 patient consultations across US ophthalmology practices
• The platform uses a surgeon-configurable AI framework designed to reflect individual counseling preferences while improving patient education and consultation efficiency

MDConsult AI announced the commercial launch of its artificial intelligence-powered pre-consultation software platform for cataract and refractive surgery practices, following a beta rollout that began in May 2026.

According to the company, the platform has been implemented across a cohort of US ophthalmology practices, completing consultations for 320 patients by early July. The software is designed to prepare patients before their in-person surgical consultation while helping practices improve workflow efficiency.

The company said its platform is built on what it describes as a "3D AI" architecture tailored to ophthalmic surgical decision-making, rather than adapting a general-purpose AI model for healthcare applications. Central to the system is a proprietary framework the company calls "deep directed discovery," which allows surgeons to customize algorithms and clinical settings so the software reflects their individual approach to patient counseling.

By incorporating surgeon-specific preferences before a patient begins interacting with the platform, MDConsult AI aims to deliver consultations that are personalized to both the patient's clinical profile and the physician's practice style.

The launch comes as cataract surgeons continue to navigate increasing complexity in IOL selection alongside ongoing reimbursement pressures and limited consultation time. The company said these trends have contributed to growing demand for tools that can improve patient education while reducing administrative burden.

"Patients today are being asked to make increasingly sophisticated lens and procedure decisions in less time than ever, with physicians under more reimbursement pressure than ever," said Gary Wortz, MD, co-founder and co-manager of MDConsult AI. "We didn't want another generic chatbot layered on top of that problem. We built a system that thinks the way each surgeon actually practices—because no two surgeons counsel patients exactly the same way, and patients deserve consultations that reflect that."

According to MDConsult AI, early use across beta practices has been associated with reduced physician and staff chair time, improved patient preparedness before surgical consultations, streamlined consultation workflows, and higher advanced-technology IOL conversion rates in some practices.

"Our beta users are some of the top cataract and refractive practices in the country, and the early data is validating exactly what we set out to build," said Tamara Bogetti, MBA, co-founder and co-manager of MDConsult AI. "We're seeing practices get real efficiency gains while patients walk into their surgical consultation more informed and more confident. That combination—efficiency and better patient experience—is very hard to achieve at the same time, and it's the reason we built this."

The platform is offered through a monthly subscription model, which the company said is intended to lower the barrier to adoption compared with larger capital equipment purchases.

MDConsult AI was developed by cataract and refractive surgeons Dr. Wortz and Joaquin De Rojas, MD, together with ophthalmology industry executives Tamara Bogetti, MBA, and Ranna Jaraha.

The company said it plans to expand beyond cataract surgery into additional ophthalmic subspecialties and, eventually, into other areas of medicine where patient education and consultation workflows present similar challenges.

• Biocon has commercially launched Yesafili (aflibercept-jbvf), an FDA-approved interchangeable biosimilar to Eylea 2 mg, in the United States.
• The approval was supported by the Phase 3 INSIGHT trial, which demonstrated comparable efficacy, safety, pharmacokinetics, and immunogenicity to reference aflibercept in patients with DME

Biocon announced the commercial launch of Yesafili (aflibercept-jbvf) in the United States, expanding the availability of an interchangeable biosimilar to Eylea (aflibercept) 2 mg for the treatment of retinal vascular diseases.

The FDA approved Yesafili in May 2024 and granted the product interchangeable designation, allowing pharmacy-level substitution for the reference product.

Yesafili is a vascular endothelial growth factor (VEGF) inhibitor indicated for the same ophthalmic conditions as reference aflibercept 2 mg, including wet age-related macular degeneration (AMD), diabetic macular edema (DME), diabetic retinopathy, macular edema following retinal vein occlusion (RVO), and retinopathy of prematurity (ROP).

"The launch of Yesafili in the US marks an important step in expanding the global availability of biosimilar aflibercept 2 mg for patients with eye conditions," said Shreehas Tambe, CEO and managing director of Biocon. "This milestone further strengthens our presence in ophthalmology and builds on our FDA approval as one of the first interchangeable biosimilars to Eylea 2 mg, advancing access to life-changing medicines for patients around the world."

FDA approval of Yesafili was supported by a comprehensive analytical, nonclinical, and clinical development program demonstrating biosimilarity to reference aflibercept 2 mg, according to Biocon.

The pivotal phase 3 INSIGHT trial evaluated Yesafili in patients with diabetic macular edema, comparing the biosimilar with reference aflibercept. According to Biocon, the study demonstrated no clinically meaningful differences between the two products in pharmacokinetics, efficacy, safety, or immunogenicity, supporting the biosimilar's approval and interchangeable designation.

• FDA pre-IND feedback supports Oculis' planned clinical development of Privosegtor for acute MS relapses, with an IND submission anticipated in the fourth quarter of 2026
• Oculis is pursuing a dual development approach by advancing the registrational PIONEER program in optic neuritis while expanding Privosegtor into the broader acute MS relapse setting

Oculis announced that it has received positive pre-investigational new drug (pre-IND) feedback from the FDA supporting the planned clinical development of Privosegtor for the treatment of acute multiple sclerosis (MS) relapses.

The company said the FDA's Division of Neurology indicated that Oculis may cross-reference data from its existing open IND for Privosegtor and that no additional preclinical studies will be required before submitting an IND for the new indication. Oculis plans to submit the IND application in the fourth quarter of 2026.

According to the company, the agency also supported key elements of the proposed development strategy, including enrolling patients experiencing optic neuritis as well as other ambulatory MS relapses, using a primary endpoint at 3 months, and administering Privosegtor at a dose of 3 mg/kg daily for 5 days, consistent with the ongoing PIONEER-1 trial.

Privosegtor is an investigational peptoid small-molecule candidate designed to provide neuroprotection. The program builds on findings from the completed phase 2 ACUITY trial in optic neuritis, where the therapy demonstrated improvements in visual function while preserving retinal ganglion cell layer integrity and reducing neurofilament levels, a biomarker associated with axonal injury.

Optic neuritis is frequently associated with new-onset MS and acute MS relapses and is considered a clinically relevant model for studying neuroprotection in inflammatory demyelinating disease. The ACUITY study enrolled patients with optic neuritis both with and without MS, providing the foundation for the company's ongoing registrational PIONEER program in optic neuritis and supporting expansion into broader MS relapse indications.

"Our recent positive engagement with the FDA supports a regulatory pathway for Privosegtor in acute MS relapses, an area of high unmet need with no currently approved neuroprotective options," said Riad Sherif, MD, chief executive officer of Oculis. "Building on positive phase 2 ACUITY data in optic neuritis, a frequent type of MS relapse, we believe Privosegtor has the potential to mitigate neuroaxonal damage and improve recovery following acute relapse events."

Dr. Sherif added that the regulatory milestone advances the company's strategy to expand its neuro-ophthalmology pipeline and that additional details regarding both the PIONEER program and the MS relapse development plan will be presented during an R&D Day planned for the fourth quarter of 2026.

• The College of Optometrists is accepting public feedback on the 2026 Guidance for Professional Practice 
• Proposed revisions include more than 75 amendments covering myopia management, infection control, glaucoma referrals, dyslexia-related advertising claims and a new duty of candour
• Three new guidance sections address artificial intelligence, expanding scope of practice, and workplace culture and governance, including expectations around appointment scheduling and patient safety

The College of Optometrists has opened a public consultation on the next edition of its Guidance for Professional Practice, inviting members, eye care professionals, patients and the public to comment on proposed changes before the consultation closes on August 3, 2026.

The guidance, which is updated every 3 years, sets the professional standards that underpin optometric practice across the UK. According to the College, the 2026 edition represents the most substantial revision in recent years, with more than 75 amendments to existing guidance and the introduction of three entirely new sections designed to reflect the evolving landscape of eye care.

Among the proposed revisions are updates addressing myopia management and the use of professional titles, alongside a new public protection position prohibiting misleading advertising claims related to dyslexia. The draft also includes revised infection prevention and control guidance aligned with Royal College of Ophthalmologists recommendations for the disinfection of reusable instruments and fitting lenses, updated glaucoma referral and community pathway guidance, and the introduction of a professional duty of candour that would apply to all registrants.

The consultation also proposes three new guidance sections focused on emerging issues affecting contemporary optometric practice.

A section on artificial intelligence and new technologies outlines expectations for clinical accountability, data governance, transparency with patients and AI literacy as AI-enabled tools become increasingly integrated into clinical practice.

A second section addresses expanding scope of practice, providing guidance for optometrists taking on new clinical responsibilities while maintaining patient safety.

The third new section, culture and governance, introduces expectations for optical businesses to avoid scheduling practices that could compromise patient safety, including routine overbooking and so-called "ghost clinics." It also emphasizes allowing sufficient appointment time to meet the needs of individual patients, including children, neurodivergent patients and those with complex care requirements.

"This is an important opportunity for everyone with an interest in eye care to have their say and influence the standards that underpin safe, effective and high-quality eye care," said Denise Voon, MCOptom, Prof Cert Med Ret OptPE, clinical advisor at the College of Optometrists. "We want to ensure the Guidance reflects people's real-world experiences, whether they're a front-line optometrist, practice owner or patient, as well as grounding the Guidance in evidence-based research. Our proposed updates reflect the realities of the modern eye care landscape, including the rapid adoption of AI, expanding clinical roles and the need for workplace cultures that support professional judgement and patient-centred safe and effective care."

Following the consultation and review of stakeholder feedback, the College plans to publish the fifth edition of the Guidance for Professional Practice in winter 2026.

• Annexon has secured a strategic credit facility with Oxford Finance providing access to up to $200 million in non-dilutive financing
• Annexon said the financing will support commercialization planning and strengthen its financial position as its lead candidates, vonaprument and tanruprubart, advance toward potential registration

Annexon has entered into a strategic credit facility agreement with Oxford Finance that provides access to up to $200 million in non-dilutive financing as the company advances two late-stage neuroinflammatory disease programs toward potential commercialization.

Under the terms of the agreement, Annexon received an initial $50 million at closing. An additional $100 million will become available upon the achievement of specified milestones related to the company's registrational programs for vonaprument and tanruprubart, while the remaining $50 million is subject to lender approval.

"This strategic facility enhances our financial and operational capabilities as we prepare for the potential global commercialization of vonaprument and tanruprubart, which combined have the potential to reach millions of patients worldwide," said Douglas Love, president and chief executive officer of Annexon. "Access to this non-dilutive capital further diversifies our capital structure, strengthens our balance sheet, and accelerates our near and long-term growth strategy."

Annexon is developing targeted immunotherapies for neuroinflammatory diseases, with vonaprument and tanruprubart representing its lead clinical-stage programs.

In January 2026, Annexon submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for tanruprubart for the treatment of Guillain-Barré syndrome (GBS).

Annexon is the developer of vonaprument, which is in phase 3 development for the treatment of dry age-related macular degeneration (AMD) with geographic atrophy (GA). Vonaprument is a first-in-kind, non-pegylated antigen-binding fragment (Fab) designed to block C1q locally in the eye with an intravitreal formulation. 

• EyePoint has completed enrollment ahead of schedule in the global phase 3 COMO and CAPRI trials evaluating Duravyu for DME, with more than 480 patients enrolled in 5 months
• The studies will compare 6-month dosing of Duravyu with on-label aflibercept, with topline efficacy and safety data expected in the fourth quarter of 2027

EyePoint Pharmaceuticals has completed patient enrollment in its two global phase 3 clinical trials evaluating Duravyu (vorolanib intravitreal insert) for the treatment of diabetic macular edema (DME), reaching a key development milestone ahead of schedule.

The company announced that more than 480 patients have been enrolled across the COMO and CAPRI studies, with full enrollment completed in 5 months. Topline results from both pivotal trials are expected in the fourth quarter of 2027.

"Completing enrollment across both COMO and CAPRI ahead of expectations is a testament to our team's exceptional execution and dedication to delivering a potentially more durable and differentiated treatment option for patients with DME, the second largest retinal disease market," said Jay S. Duker, MD, president and chief executive officer of EyePoint. "Duravyu's compelling efficacy and safety profile, combined with positive feedback on our trial design from both the FDA and EMA, underscores our confidence in the program as we advance toward topline data in DME anticipated next year."

COMO and CAPRI are global, randomized, double-masked, active-controlled, noninferiority phase 3 studies comparing a 2.7 mg intravitreal insert of Duravyu with on-label 2 mg aflibercept in patients with DME. The trials include both treatment-naïve and previously treated patients.

Participants are randomized to receive either Duravyu or aflibercept on Day 1. Patients assigned to Duravyu are scheduled for repeat dosing every 6 months through a standard intravitreal injection administered in the physician's office.

The primary endpoint is noninferior change from baseline in best corrected visual acuity (BCVA), assessed as the blended average of weeks 52 and 56, compared with aflibercept. Secondary endpoints include safety, reduction in treatment burden, the proportion of eyes requiring no supplemental aflibercept injections, and anatomical outcomes measured by optical coherence tomography (OCT).

According to EyePoint, the phase 3 program was designed based on results from the phase 2 VERONA trial, in which Duravyu 2.7 mg demonstrated early and sustained improvements in BCVA, a two-thirds reduction in treatment burden, prolonged time to first supplemental injection compared with aflibercept, and improvements in central subfield thickness.

The company said the phase 3 development program was developed in alignment with both the FDA and the European Medicines Agency (EMA).

In May 2026, an independent Data Safety Monitoring Committee reviewed masked safety data from the company's ongoing phase 3 wet age-related macular degeneration and DME programs and recommended that both studies continue without protocol modifications. EyePoint reported that Duravyu has now been evaluated in more than 190 patients across four completed clinical trials, with no Duravyu-related safety concerns observed.

• Essilor has launched Varilux Shift, an AI-designed entry-level progressive lens intended to address the evolving visual behaviors of today's presbyopic patients
• The company says AI analyzed millions of wearer data points to optimize near vision zone placement, with simulations showing improved design softness and a larger distance viewing area compared with standard progressive lenses

Essilor has introduced Varilux Shift, a new progressive lens designed using artificial intelligence to address the changing visual demands of today's presbyopic patients.

The company said the new addition expands its Varilux portfolio by bringing AI-driven design technology to an entry-level progressive lens, with a focus on improving near vision access, distance vision, and wearer adaptation.

According to Essilor, modern visual behavior has become increasingly dynamic, with individuals making approximately 150,000 focus shifts each day as they transition between digital devices and other viewing tasks. The company said these changing habits require progressive lens designs that enable smooth, natural transitions across multiple viewing distances.

"The way presbyopes use their eyes today has drastically changed from the past, becoming more dynamic due to the increased utilization of digital devices," said Avanti Upponi, senior director of lens product marketing, US, at EssilorLuxottica. "More than ever before, presbyopes today need a progressive lens solution that optimizes the placement of the near vision zone, provides a large far vision viewing area, and manages side effects—all while being easy to adapt to. That's why we are excited to launch Varilux Shift lenses as the go-to entry-level Varilux design, rounding out our AI-powered portfolio and bringing innovation to every patient, at every price point."

Essilor said Varilux Shift was developed using artificial intelligence to analyze millions of wearer data points. According to the company, the analysis identified behavioral differences among today's presbyopes and enabled AI models to predict variations in gaze declination based on refractive error and addition values.

These insights informed the positioning of the lens' near vision zone. Essilor said its iComfort technology optimizes the placement of this zone to better align with contemporary visual habits, providing easier access to near vision while supporting more intuitive adaptation for first-time and existing progressive lens wearers.

The company reported that AI simulations comparing Varilux Shift with standard progressive lenses demonstrated a 34% improvement in design softness, which is intended to reduce the "swim effect," and an 18% enlargement of the far vision viewing area. Essilor also cited wearer evaluation data indicating that 91% of users adapted to Varilux Shift lenses and 89% reported easy access to the near vision zone.

The company said the lens is designed to deliver the visual performance and wearer experience associated with the Varilux brand while expanding access to AI-enhanced progressive lens technology.

• Researchers developed photoswitchable prosthe6 compounds that restored vision-related behaviors in zebrafish and mouse models of retinal degeneration without requiring gene therapy or implanted retinal prostheses
• The compounds target ON bipolar cells through the mGlu6 pathway, functioning under ambient visible light and demonstrating activity following both intraocular injection and topical eye-drop administration in preclinical studies
• The technology remains in preclinical development, with ongoing safety, formulation, and translational studies aimed at advancing the compounds toward future clinical trials

Researchers led by the Institute for Bioengineering of Catalonia (IBEC) in Barcelona, Spain, have developed a new class of photoswitchable small-molecule compounds that restored vision-related behaviors in animal models of retinal degeneration, advancing a noninvasive approach to vision restoration that does not require gene therapy or implanted devices.

The findings, published in the Journal of the American Chemical Society, and detailed in an article on the IBEC website, describe a family of photopharmacological compounds known as prosthe6, which are designed to mimic the function of lost photoreceptors by reactivating preserved retinal circuitry. The compounds demonstrated preliminary safety profiles and restored visual function in zebrafish and mouse models of blindness caused by retinal degeneration.¹

Photoreceptor degeneration underlies conditions including age-related macular degeneration (AMD) and retinitis pigmentosa (RP), which together affect an estimated 200 million people worldwide. While the downstream retinal network often remains structurally intact, it no longer receives the light input necessary to transmit visual information to the brain. Existing vision restoration strategies—including gene therapy, retinal prostheses, and optogenetics—have shown promise but remain limited by mutation specificity, invasiveness, or the need for specialized equipment.

The IBEC-led consortium sought to restore visual signaling by targeting the retina at a point that more closely resembles natural vision.

"These molecules do not cure blindness, because they do not address the cause of photoreceptor degeneration," said Pau Gorostiza, PhD, ICREA research professor at IBEC and co-leader of the study. "But they are remarkably effective at restoring sight, and they do so using a very simple and potentially patient-friendly approach."

Photopharmacology uses light to reversibly control the activity of therapeutic compounds. To create prosthe6, investigators modified drug molecules with light-sensitive molecular switches that change conformation in response to visible light, enabling light-dependent activation of retinal signaling pathways. Rather than bypassing retinal processing, the compounds target ON bipolar cells, which normally receive input directly from photoreceptors.

"Our goal was to restore vision using a molecular mechanism that is as close as possible to how the healthy retina works," said co-first author Rosalba Sortino, PhD, currently a postdoctoral researcher at IBEC. "Instead of bypassing retinal processing, we aimed to reactivate it right at the same level of the retinal circuit as the lost photoreceptor cells."

In blinded zebrafish larvae, prosthe6 restored optokinetic responses, a commonly used measure of visual function. In mouse models of AMD and RP, treatment restored innate light-avoidance behavior. Normally sighted mice preferentially remain in dark environments, whereas blind mice lose this behavior because they cannot detect light. Following treatment, blind mice again demonstrated a spontaneous preference for dark environments under lighting conditions comparable to typical indoor illumination or an overcast day. According to the investigators, the recovery occurred without behavioral training, suggesting restoration of functional light perception sufficient to guide natural behaviors.

The researchers reported that prosthe6 activates the metabotropic glutamate receptor 6 (mGlu6) pathway in ON bipolar cells, effectively replacing the signaling normally provided by photoreceptors. Upon exposure to light, the molecules undergo a structural change that initiates retinal signaling in a manner intended to resemble physiological visual processing.

Unlike some optogenetic approaches, the compounds were designed to function under ambient visible light and do not require high-intensity illumination or external light-amplifying devices. The molecules are also water soluble, potentially enabling multiple routes of administration.

The work builds on more than a decade of research and involved investigators from the University of Alcalá, the Institute of Advanced Chemistry of Catalonia (IQAC-CSIC), the University of Barcelona, the Ramón y Cajal Institute for Health Research (IRYCIS), the Autonomous University of Barcelona, and the Fundació Eduard Soler.

According to the research team, the prosthe6 platform is protected by patent, and ongoing efforts are focused on optimizing formulation, evaluating safety, and extending the duration of visual restoration. The investigators are also collaborating with Eyelumina, a spin-off company in formation, to support translational development and future clinical studies.

Reference

1. Sortino R, González-Díez A, Milla-Navarro S, et al. Restoration of saccadic eye movements and visually guided behavior in ambient white light with photoswitchable small molecules. J Am Chem Soc. Published online July 15, 2026. doi:10.1021/jacs.5c18611.

The research, conducted by a team of ophthalmic and economics investigators, analyzed 4 years of anonymized patient and operational data from 20 US eye care practices. According to the findings, average annual customer-level profits were $436 for spherical soft contact lens wearers, $453 for toric lens wearers, and $485 for multifocal contact lens wearers. By comparison, annual profits averaged $244 for single-vision glasses patients and $376 for progressive glasses patients.

The study incorporated anonymized records from 30 patients per participating practice, along with operational metrics including professional fees, chair time, staff compensation, and secondary revenue streams. Based on these data, the investigators concluded that soft contact lens patients provide a meaningful profitability advantage over equivalent glasses-only patients, with potential financial benefits increasing over a patient's lifetime of lens wear.

The analysis was led by Professor Philip Morgan of the University of Manchester, Professor Lyndon Jones of the Centre for Ocular Research & Education (CORE) at the University of Waterloo, and Professors Ash Morgan and John Whitehead of the Department of Economics at Appalachian State University. CLI commissioned the research as part of its multiyear "See Tomorrow" initiative.

"It’s clear that contact lens customers can generate greater average annual profit, even with higher service and product costs," Prof. Morgan said in a statement. "Our findings suggest that recurring purchases, greater examination frequency, and opportunities for ancillary spending may make contact lens wearers particularly attractive from a customer lifetime value perspective."

According to CLI, the analysis represents the first published evaluation of contact lens profitability in the United States. The organization noted that the study follows the London Business School's "Seeing Things Clearly" report, published 25 years ago, which examined the economics of contact lens practice across five European markets.

"The new data squarely challenges profitability myths that can creep into conversation despite a lack of evidence," said CLI Executive Director Stan Rogaski. "For instance, prior CLI See Tomorrow work showed that more than half of eye care practices don't even attempt to quantify the business impact of their contact lens patients. Among those who do, they significantly underestimate the relative profitability compared to glasses-only patients."

CLI said the complete analysis will be published later this year as part of a comprehensive See Tomorrow report.

• PROSE treatment was associated with statistically significant improvements in both Mackie stage and visual acuity among 87 patients with neurotrophic keratitis
• Patients reached their lowest Mackie stage in an average of 31.18 days following treatment, indicating relatively prompt corneal healing
• The retrospective findings support considering PROSE as a therapeutic option for neurotrophic keratitis across a range of disease severities while highlighting the need for further prospective research

BostonSight reported new data supporting the use of Prosthetic Replacement of the Ocular Surface Ecosystem (PROSE) treatment for patients with neurotrophic keratitis (NK), according to findings presented at the Association for Research in Vision and Ophthalmology (ARVO) annual meeting. The poster, "Mackie Stage Improvement in Neurotrophic Keratopathy with Use of PROSE," was authored by Ken Whang, Estelle Crowley, and Daniel Brocks, MD.

PROSE devices have been used to manage a range of ocular surface diseases, but their effectiveness across the spectrum of neurotrophic keratitis severity has not been well characterized, according to BostonSight. The retrospective observational study evaluated PROSE as a therapeutic intervention for patients with NK, a vision-threatening degenerative corneal disease caused by impaired corneal nerve function. Disease severity was assessed using the three-stage Mackie Classification system.

Investigators reviewed clinical data from November 2008 through September 2023, analyzing outcomes from 87 eyes of 87 patients diagnosed with NK. The cohort included 8 eyes with Stage 0 disease, 57 with Stage 1, 17 with Stage 2, and 5 with Stage 3 disease. Paired t-tests and Wilcoxon rank tests were used to compare outcomes before and after PROSE treatment, with statistical significance defined as a p-value below 0.05.

According to the findings, patients experienced statistically significant improvements in both mean Mackie stage and mean visual acuity following PROSE treatment. The average time to reach the lowest Mackie stage was 31.18 days, suggesting relatively rapid corneal healing in the study population.

"The study concludes that PROSE treatment is an effective tool and should be considered when treating neurotrophic keratitis," said Daniel Brocks, MD, chief medical officer at BostonSight. "Neurotrophic keratitis is a stubborn disease, which has high risk of causing vision loss. These results illustrate the effectiveness of PROSE to save vision and induce prompt corneal tissue healing."

The investigators noted that the findings expand the evidence supporting PROSE treatment in patients with neurotrophic keratitis across multiple stages of disease severity. While the retrospective design limits conclusions regarding causality, the observed improvements in both disease stage and visual outcomes suggest the therapy may provide meaningful clinical benefit for patients with this challenging ocular surface disorder.

The financing will support completion of the company's ongoing clinical studies, fund a planned phase 3 program expected to begin in the first half of 2027, and support pre-commercialization activities. Claris also expects to report proof-of-concept data from its ongoing LSCD study during the second half of 2026.

CSB-001 is being developed as a topical therapy for LSCD, a sight-threatening disease in which damage to limbal stem cells prevents normal regeneration of the corneal surface. The investigational recombinant human deleted hepatocyte growth factor (dHGF) therapy is designed to promote corneal epithelial regeneration while modulating inflammation and fibrosis. According to Claris, clinical data generated to date have demonstrated substantial improvements in visual acuity.

If approved, CSB-001 could become the first pharmacologic treatment for LSCD, a condition for which no drug therapies are currently approved. The company estimates that at least 30,000 patients in the United States are actively managed for LSCD, although the true prevalence is likely higher because of underdiagnosis.

The Series B round was co-led by new investors Samsara Biocapital and Catalio Capital Management, with participation from Adage Capital Management, Sofinnova Investments, Aisling Capital, and ADAR1 Capital Management. Existing investors Novo Holdings, Janus Henderson Investors, and Mass General Brigham Ventures also participated.

Proceeds from the financing will fund completion of Claris' ongoing open-label proof-of-concept study in 63 patients with LSCD, as well as a prospective natural history study intended to inform pivotal trial design and site selection.

The company plans to launch two pivotal studies during the first half of 2027 enrolling approximately 400 patients with LSCD. The trials will compare CSB-001 with vehicle, with visual acuity serving as the primary efficacy endpoint, supported by anatomical measures.

Leadership expansion

Coinciding with the financing, Claris appointed Stephen Brady as president and CEO and Brian Baum as chief commercial officer.

Mr. Brady brings nearly three decades of experience in corporate strategy, business development, finance, and executive leadership across biotechnology companies. Most recently, he served as chairman and chief executive officer of Tempest Therapeutics. Earlier in his career, he held leadership positions at Immune Design, where he helped guide the company through its initial public offering and eventual acquisition by Merck, and at Proteolix, where he led strategic initiatives culminating in its acquisition by Onyx Pharmaceuticals.

Mr. Baum joins Claris with more than 20 years of commercial leadership experience. Most recently, he served as senior vice president at Dompé Pharmaceuticals, where he led commercial initiatives supporting the U.S. launch and growth of Oxervate for neurotrophic keratitis. Previously, he spent a decade at Genentech in US and global commercial leadership roles, including work supporting the commercialization of Lucentis across multiple retinal disease indications.

"I'm thrilled to join Claris at such a pivotal moment in the company's evolution," Mr. Brady said in a company statement. "The strong interest in CSB-001 reflects both its promise for patients and commercial potential. With the company financed through phase 3 and the team in place to execute, we're ready to advance CSB-001 from a position of strength. The prospect of significantly improving vision with a convenient eye drop is a tremendous advance, and I'm energized by the opportunity to take on a blinding disease like LSCD."

The company also named Marc de Garidel chairman of the board. De Garidel has held senior leadership positions at multiple biotechnology and pharmaceutical companies, including Abivax, CinCor Pharma, Corvidia Therapeutics, Ipsen, Eli Lilly and Company, and Amgen. In conjunction with the financing, Mike Dybbs, PhD, partner at Samsara Biocapital; Matthew Hobson, PhD, principal at Catalio Capital Management; and Maha Radhakrishnan, MD, executive partner at Sofinnova Investments, joined Claris' board of directors.

Claris noted that it maintains a safety data-sharing collaboration with Kringle Pharma, which is developing oremepermin alfa for non-ophthalmic indications, to support the development of CSB-001.