Eyewire+ - Latest News https://eyewire.news The latest news stories from Eyewire+. en-us Wed, 24 Jun 2026 01:10:30 GMT Wed, 24 Jun 2026 01:10:30 GMT Core4 Cataltheia Group Announces Peer-Reviewed Clinical Validation of Deseyne Presbyopia Contact Lens https://eyewire.news/news/cataltheia-group-announces-peer-reviewed-clinical-validation-of-deseyne-presbyopia-contact-lens Tue, 23 Jun 2026 14:55:58 GMT https://eyewire.news/news/cataltheia-group-announces-peer-reviewed-clinical-validation-of-deseyne-presbyopia-contact-lens The Cataltheia Group and its US subsidiary, Bruno Vision Care, announced the publication of clinical data in Optometry and Vision Science (OVS) supporting the performance of the Deseyne daily disposable contact lens for presbyopia.1 According to The Cataltheia Group, the publication represents the first peer-reviewed clinical validation of the FDA-cleared soft contact lens featuring Extended Depth of Focus (EDOF) technology.

The study, authored by Mark A. Bullimore, MCOptom, PhD, FAAO, and colleagues, evaluated the lens in a randomized, crossover, non-dispensing clinical trial involving 78 habitual soft contact lens wearers with presbyopia between the ages of 45 and 70 years. Participants were enrolled across three clinical sites in the United States.

Investigators reported that the Deseyne lens achieved a statistically significant increase in depth of focus compared with a monofocal control lens while maintaining distance vision performance. The study also found improvements in both near and intermediate visual acuity.

“Bringing the first FDA-cleared daily disposable EDOF lens for presbyopia from concept to peer-reviewed publication is a milestone for our team and for the category,” said Eddie Catalfamo, co-founder and chief executive officer of The Cataltheia Group and a study co-author. “Presbyopia is one of the largest unmet needs in vision care, and our goal with Deseyne is to give eye care professionals a meaningful new option for their patients.”

Unlike traditional multifocal contact lenses that use simultaneous-image optics or multiple optical powers to provide vision at different distances, the Deseyne lens employs an extended depth of focus optical architecture designed to broaden the range over which objects remain in acceptable focus. According to the published study, the lens incorporates a spherical anterior optical surface across an 11-mm optic zone and a central 1.0-mm optically inactive region. Researchers reported that the design produced a statistically significant increase in depth of focus relative to a single-vision control lens.

The investigators reported a mean increase in depth of focus of +0.78 diopters compared with the monofocal control lens.

Additional findings included:

  • Approximately 1.6 lines of improvement in near visual acuity
  • Approximately 1.4 lines of improvement in intermediate visual acuity
  • Distance visual acuity that remained statistically noninferior to the monofocal control lens
  • No adverse events observed during the study

Among participants aged 60 years and older, the lens demonstrated an increase in depth of focus of +0.88 diopters, along with approximately 2.0 lines of improvement in near visual acuity and 2.2 lines of improvement in intermediate visual acuity.

Bruno Vision Care said diagnostic kits will be available to eye care professionals ahead of the anticipated U.S. commercial launch of the Deseyne Daily Disposable Extended Depth of Focus soft contact lens for presbyopia, which is expected by the end of the fourth quarter of 2026.

Reference

1. Bullimore MA, Slonim C, Montaquila S, et al. A randomized crossover clinical trial of the Deseyne contact lens for presbyopia with extended depth of focus. Optometry and Vision Science. Published June 20, 2026.

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CORE Explores AI's Emerging Role in Myopia Management in Latest Contact Lens Update https://eyewire.news/news/core-explores-ais-emerging-role-in-myopia-management-in-latest-contact-lens-update Tue, 23 Jun 2026 13:05:06 GMT https://eyewire.news/news/core-explores-ais-emerging-role-in-myopia-management-in-latest-contact-lens-update Key Takeaways

  • Issue 90 of Contact Lens Update focuses on AI applications in myopia management, including progression prediction, treatment personalization, and clinical decision support
  • Experts featured in the issue emphasize that current AI tools remain strongest in screening and forecasting trends, while personalized treatment guidance requires further development and broader data integration

The Centre for Ocular Research & Education (CORE) has dedicated Issue 90 of Contact Lens Update to the growing role of artificial intelligence (AI) in myopia management, examining the technology's potential to improve prediction, personalize treatment, and support clinical decision-making.

The complimentary bi-monthly publication is available through ContactLensUpdate.com and brings together perspectives from researchers, clinicians, and educators on the opportunities and limitations of AI in contemporary myopia care.

"AI is not a substitute for clinicians, but it can augment their clinical reasoning," said Daddi Fadel, adjunct assistant professor at the University of Waterloo and a consultant for CORE. "For myopia management, systems can already help synthesize complex scientific evidence, project progression, and support personalized treatment decisions. This issue provides practitioners with a practical understanding of how AI can be integrated into daily care to improve outcomes for young myopic patients."

The issue opens with an editorial by Jeffrey J. Walline, distinguished professor and associate dean at The Ohio State University College of Optometry. Mr. Walline argues that while current AI models can predict average myopia progression across populations with reasonable accuracy, they remain limited in forecasting progression for individual patients. He notes that genuinely transformative AI capable of delivering highly personalized myopia care has yet to emerge but is likely to become a reality within the profession's lifetime.

A feature article by Nicola Logan, professor of optometry and associate dean for Research & Enterprise at Aston University in the United Kingdom, examines the expanding use of AI in myopia research. Ms. Logan reports that most current applications remain focused on screening and progression prediction rather than guiding treatment decisions. She concludes that broader international data sharing, more diverse multi-ethnic datasets, and integrated clinical decision-support tools will be necessary before AI can achieve meaningful clinical transformation.

To help practitioners translate evidence into practice, CORE's clinical insight section provides summaries of the seven International Myopia Institute reports alongside clinically focused infographics. The resources are intended to support risk assessment, treatment selection, patient communication, and other aspects of myopia management.

The issue also highlights presentations from "OPTOMYOPIA," with clinician and professional educator Epifanio Ruiz Campos discussing how AI-powered augmented intelligence platforms can support clinical decision-making. According to the report, OPTOMYOPIA integrates peer-reviewed scientific literature with patient-specific information to synthesize evidence, assist with risk stratification, and support personalized treatment planning. The platform is presented as an example of how AI can enhance, rather than replace, clinician expertise.

Contact Lens Update receives educational support from Alcon, CooperVision, and Johnson & Johnson Vision.

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Oculgen Announces First US Patient Enrolled in STAT Trial of OCUL101 for Wet AMD https://eyewire.news/news/ocugen-announces-first-us-patient-enrolled-in-stat-trial-of-ocul101-for-wet-amd Tue, 23 Jun 2026 12:55:42 GMT https://eyewire.news/news/ocugen-announces-first-us-patient-enrolled-in-stat-trial-of-ocul101-for-wet-amd Key Takeaways

  • The first US participant has been enrolled in the phase 2/3 STAT trial evaluating OCUL101 for treatment-naïve wet AMD
  • OCUL101 is a dual-target investigational biologic designed to bind both VEGF and complement C5, addressing angiogenic and inflammatory pathways implicated in AMD
  • The global study plans to enroll approximately 255 participants across 70 sites in the United States and Europe

Shenzhen Oculgen Biomedical Technology Co. (Oculgen) announced that the first US participant has been enrolled in the phase 2/3 STAT study (NCT07520318), which is evaluating the investigational agent OCUL101 in adults with treatment-naïve wet age-related macular degeneration (AMD).

The STAT study, short for STop ATrophy in AMD, is a multicenter, randomized, double-masked, active comparator-controlled trial designed to evaluate the efficacy and safety of two dose levels of OCUL101 compared with aflibercept 2 mg. The study is expected to enroll approximately 255 participants and will follow patients for 96 weeks. The global STAT program is expected to include approximately 70 clinical sites, comprising 46 sites in the United States and 24 sites across Europe. 

According to Oculgen, pre-specified efficacy and safety data collected through Week 36 are intended to support future regulatory discussions and may inform a planned Biologics License Application submission.

The enrollment marks a milestone for the global development program and follows clearance of Oculgen's investigational new drug application by the FDA. The first US participant was enrolled at a clinical site in Los Angeles.

OCUL101 is an investigational humanized bispecific antibody-like trap administered by intravitreal injection. The agent is designed to target two biological pathways implicated in AMD by binding vascular endothelial growth factor (VEGF) and complement component C5, which has been associated with inflammatory and atrophic processes in the disease.

According to Oculgen, current anti-VEGF therapies are effective at controlling neovascularization but are not approved to prevent retinal atrophy. OCUL101's dual-target mechanism is intended to address both angiogenic and complement-mediated pathways with a single therapeutic molecule. However, the clinical benefit of this approach remains under investigation and has not yet been established.

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Cloudbreak Pharma Reports Findings of Survey Highlighting Unmet Need for Pinguecula Treatment https://eyewire.news/news/cloudbreak-pharma-reports-findings-of-survey-highlighting-unmet-need-for-pinguecula-treatment Mon, 22 Jun 2026 14:11:37 GMT https://eyewire.news/news/cloudbreak-pharma-reports-findings-of-survey-highlighting-unmet-need-for-pinguecula-treatment Cloudbreak Pharma reported findings from a market research survey suggesting that pinguecula significantly affects patients' quality of life and that there is substantial interest in a prescription treatment option for the condition, which currently lacks any FDA-approved pharmaceutical therapies.

The survey, conducted by an independent third-party market research firm during April and May 2026, included 1,020 U.S. adults aged 35 to 80 who had visited an eye care professional within the previous 5 years. Participants completed an internet-based questionnaire examining their experience with pinguecula and their interest in potential treatment options.

According to the survey results, approximately 10% of respondents self-identified as currently having pinguecula and reported being under the care of an eye care provider for the condition. Cloudbreak noted that the prevalence aligns with published epidemiologic data for moderate-to-severe disease. Published studies have also shown that the incidence of pinguecula increases with age and may affect roughly half of older adults.

Among respondents with pinguecula, more than three-quarters described the condition as "moderately or greatly bothersome." Commonly reported symptoms included ocular irritation, itching, and redness. Patients also identified several environmental factors that exacerbated symptoms, including allergies, dry or hot weather, excessive light exposure, smoking, and wind.

Interest in a prescription treatment option was also assessed. When informed that no FDA-approved pharmaceutical therapy currently exists for pinguecula, respondents rated their interest in a potential prescription treatment at an average of 3.4 on a 0-to-4 scale, indicating moderate-to-high interest.

“These data highlight the significant unmet need that we are working to address with CBT-004. We observed impressive efficacy in our phase 2 study, notably the statistically significant reductions in hyperemia and foreign body sensation from baseline that were seen as early as the first study visit on day seven," said Abu Abraham, MD, Chief Medical Officer at Cloudbreak Pharma. "We plan to build upon these compelling results as we initiate a rigorous and efficiently designed phase 3 program early next year.”

Cloudbreak stated that it intends to submit the complete survey findings for publication in a peer-reviewed medical journal in the coming months.

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Vermont Enacts Optometric Scope Expansion Law Authorizing Advanced Procedures https://eyewire.news/news/vermont-enacts-optometric-scope-expansion-law-authorizing-advanced-procedures Mon, 22 Jun 2026 13:30:16 GMT https://eyewire.news/news/vermont-enacts-optometric-scope-expansion-law-authorizing-advanced-procedures Key Takeaways

  • Beginning July 1, 2028, eligible optometrists in Vermont will be authorized to perform specified laser and minor surgical procedures after completing required training
  • Vermont becomes the 17th state to authorize ophthalmic laser procedures by optometrists, following similar scope expansions in Kansas and Tennessee earlier in 2026

Vermont has enacted legislation that expands the scope of practice for optometrists and establishes a new pathway for qualified doctors of optometry to perform additional in-office eye care procedures, including certain ophthalmic laser treatments.

Gov. Phil Scott signed the measure into law on June 18. The legislation creates an Advanced Therapeutic Procedures Specialty License and authorizes eligible Vermont optometrists who complete required training to perform specified procedures beginning July 1, 2028.

According to the Vermont Optometric Association (VOA), the law makes Vermont the 17th state to authorize optometrists to perform ophthalmic laser procedures. The measure follows similar scope-of-practice expansions enacted earlier this year in Kansas and Tennessee.

“This is a historic day for Vermont patients and doctors of optometry,” Tina Keshava, OD, president of the VOA, said in a statement. “For years, Vermont doctors have worked to ensure our laws reflect the education and training we receive today. This legislation will improve access to care across our state and help more patients receive the services they need closer to home.”

Under the new law, optometrists who obtain the specialty license and complete the required training will be permitted to perform a range of procedures, including:

  • Laser capsulotomy
  • Laser peripheral iridotomy
  • Selective laser trabeculoplasty
  • Corneal cross-linking
  • Removal of certain eyelid and periocular lesions
  • Repair of minor eyelid injuries
  • Periocular injections for medications and anesthesia

The VOA led advocacy efforts supporting the legislation, which the organization described as the culmination of a multi-year campaign focused on aligning state practice laws with contemporary optometric education and training. The effort also received support from the American Optometric Association’s State Government Relations Center.

The enactment continues a broader national trend of states revisiting optometric scope-of-practice laws. Tennessee and Kansas became the 15th and 16th states, respectively, to approve similar expansions earlier in 2026. Implementation of the new specialty license and training requirements is expected to occur ahead of the July 2028 effective date for the authorized procedures.

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Atsena Doses First Patient in Phase 3 LIGHTHOUSE Trial of Gene Therapy for XLRS https://eyewire.news/news/atsena-doses-first-patient-in-phase-3-lighthouse-trial-of-gene-therapy-for-xlrs Mon, 22 Jun 2026 13:14:08 GMT https://eyewire.news/news/atsena-doses-first-patient-in-phase-3-lighthouse-trial-of-gene-therapy-for-xlrs Key Takeaways

  • Atsena Therapeutics has dosed the first patient in the phase 3 pivotal cohort of the LIGHTHOUSE trial evaluating ATSN-201 for X-linked retinoschisis
  • The 76-patient study will assess microperimetry at 52 weeks as its primary endpoint, with enrollment expected to conclude in the first quarter of 2027
  • ATSN-201 previously demonstrated encouraging structural and functional improvements in phase 1/2 testing, and no approved treatments currently exist for XLRS

Atsena Therapeutics has dosed the first patient in the phase 3 pivotal cohort of its LIGHTHOUSE clinical trial evaluating ATSN-201, an investigational gene therapy for X-linked retinoschisis (XLRS).

The clinical-stage gene therapy company reported that enrollment began in May and has already reached approximately 10% of the planned study population. Atsena expects enrollment to continue rapidly as additional trial sites become active across North America and Europe. The company anticipates completing enrollment by the end of the first quarter of 2027. Topline data are expected in the first half of 2028, with a Biologics License Application filing targeted for the second half of that year.

“Brisk enrollment of the study reflects the significant unmet need in XLRS, a disease for which no approved treatments exist, and strong interest from leading clinicians and patients who have been following ATSN-201's clinical progress,” said Kenji Fujita, MD, chief medical officer of Atsena, in a company statement.

According to Fujita, early clinical findings from the phase 1/2 portion of the LIGHTHOUSE study demonstrated closure of schisis cavities and improvements in retinal and visual function in a majority of treated patients. The company reported that these outcomes have remained durable through at least one year of follow-up.

LIGHTHOUSE Phase 3 Design

The pivotal portion of the LIGHTHOUSE trial is expected to enroll 76 patients with XLRS, including adults and children as young as 6 years of age, at clinical centers throughout North America and Europe. Participants are being randomized approximately 1:1 to either receive ATSN-201 or enter an observation control arm. Patients assigned to the control group will be observed for 12 months before being offered the option to receive treatment.

The study's primary endpoint is change in microperimetry at 52 weeks, an outcome measure selected in alignment with both the FDA and the European Medicines Agency (EMA). Secondary endpoints include assessments of visual acuity and retinal structure using optical coherence tomography.

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Lexitas Pharma Services Named Octane Preferred Advisor https://eyewire.news/news/lexitas-pharma-services-named-octane-preferred-advisor Fri, 19 Jun 2026 17:52:54 GMT https://eyewire.news/news/lexitas-pharma-services-named-octane-preferred-advisor Lexitas Pharma Services has been named the newest Octane Preferred Advisor (OPA), expanding the resources available to founders, startups, and growth-stage companies developing ophthalmic drugs and devices within Octane’s innovation ecosystem.

According to the companies, the partnership brings together Octane’s network-building and growth support capabilities with Lexitas’ specialized ophthalmology clinical development expertise. As a full-service clinical research organization focused exclusively on ophthalmology, Lexitas has spent the past 15 years supporting sponsors across medical, scientific, regulatory, and clinical operations.

According to the company, Lexitas has supported more than 170 clinical trials spanning phase 1 through phase 4 development across anterior and posterior segment indications. Its global investigator network includes more than 700 sites, and the organization has enrolled more than 22,000 patients in anterior segment studies. The company also reports involvement in more than 40 posterior segment studies, including cell and gene therapy programs and rare disease research.

“At Lexitas, we partner with small to midsize biotech and medtech companies to help them advance ophthalmic innovations that can meaningfully improve patients’ lives,” said Jeanne Hecht, CEO and chairwoman of the board of Lexitas Pharma Services. “Partnering with Octane strengthens our ability to support early-stage and emerging organizations at a critical point in their journey, combining Octane’s expertise in helping founders build high-growth companies with Lexitas’ clinical development expertise. Together, we are helping innovators turn promising science into well-designed clinical programs built for long-term success.”

Lexitas said it has supported the clinical development of five FDA-approved ophthalmic products, including Xiidra, EyeSuvis, Inveltys, and Miebo. The company also reported meeting or exceeding all major study milestones during the past 24 months and maintaining a 99% clinical research associate retention rate.

The CRO offers end-to-end ophthalmic development services, including regulatory strategy, protocol design, medical monitoring, biometrics, medical and regulatory writing, project management, clinical operations, and integrated reading center services. Through a strategic partnership with NAMSA, the company also supports medical device development and regulatory programs, including combination products and device-focused innovations.

Lexitas has expanded its retinal and posterior segment capabilities through the acquisitions of Erie Retina Research, CASExERIE, and Element Erie, creating what the company describes as an integrated retina research ecosystem designed to strengthen site access, scientific expertise, and specialized development capabilities.

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Potential Drug Signals Linked to Wet AMD Identified in Integrative Analysis https://eyewire.news/news/potential-drug-signals-linked-to-wet-amd-identified-in-integrative-analysis Fri, 19 Jun 2026 13:47:30 GMT https://eyewire.news/news/potential-drug-signals-linked-to-wet-amd-identified-in-integrative-analysis Key Takeaways

  • Five medications were identified as having elevated wet AMD reporting signals in FAERS data
  • Integrative proteogenomic analyses implicated six candidate genes, with WARS1 showing evidence supporting colocalization with wet AMD risk
  • Immune and inflammatory pathways emerged as potential mechanistic links warranting further study

A large pharmacovigilance and proteogenomic analysis has identified several commonly used medications that may be associated with an increased reporting risk of wet age-related macular degeneration (AMD), while also highlighting potential molecular pathways that could help explain these signals.1

Investigators from China combined data from the US Food and Drug Administration Adverse Event Reporting System (FAERS) with genetic, proteomic, and single-cell transcriptomic analyses to identify drug-associated risk signals and explore their biological underpinnings. The findings were published in Eye.

The researchers first analyzed FAERS reports for disproportionate reporting of wet AMD and identified five drugs associated with elevated reporting signals: apixaban, carbamazepine, latanoprost, rituximab, and semaglutide.

To move beyond signal detection and investigate potential mechanisms, the team mapped drug targets and integrated summary-based Mendelian randomization and colocalization analyses using cis-protein quantitative trait loci datasets. This approach identified six genes that may play a role in wet AMD susceptibility: IGFBP6, MAPKAPK2, NFKB1, RGMA, RNASE1, and WARS1. Among these candidates, WARS1 demonstrated evidence supporting colocalization, strengthening its candidacy as a potentially relevant molecular mediator.

Single-cell RNA sequencing analyses further showed that most candidate genes were predominantly expressed in vascular-remodeling endothelial cells, while WARS1 also exhibited strong expression specificity in monocytes. These findings suggest that vascular and immune cell populations may contribute to the biological processes linking drug exposure and disease development.

Additional pathway analyses pointed toward inflammatory and immune-related mechanisms, including involvement of Toll-like receptor, tumor necrosis factor (TNF), and NF-kappa B signaling pathways. The authors noted that these pathways have previously been implicated in retinal inflammation and angiogenesis, two central features of nAMD pathogenesis.

The investigators emphasized that the findings should be interpreted as hypothesis-generating rather than evidence of causality. Pharmacovigilance databases are subject to reporting biases and cannot establish definitive drug-related risk. Nevertheless, the integration of adverse event reporting with human genetic and proteomic data provides a framework for prioritizing signals for future laboratory and clinical investigation.

According to the authors, the results may help guide future research aimed at clarifying whether these observed associations reflect true biological effects and whether the identified genes could serve as therapeutic targets or biomarkers in wet AMD.

Reference

1. Source: Sun H, Bu F, Xin X, et al. “Uncovering drug-associated risk signals for neovascular age-related macular degeneration: an integrative pharmacovigilance and proteogenomic study,” Eye (2026).

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Foundation Fighting Blindness Receives $1 Million Commitment to Advance Gene-Agnostic IRD Therapies https://eyewire.news/news/foundation-fighting-blindness-receives-1-million-commitment-to-advance-gene-agnostic-ird-therapies Fri, 19 Jun 2026 13:32:33 GMT https://eyewire.news/news/foundation-fighting-blindness-receives-1-million-commitment-to-advance-gene-agnostic-ird-therapies Key Takeaways

  • A Race Against Blindness has committed $1 million to the Foundation Fighting Blindness and the RD Fund to advance gene-agnostic therapies for inherited retinal diseases
  • The funding includes $775,000 for the RD Fund, which will be matched dollar-for-dollar, and $225,000 for a Foundation Fighting Blindness research award
  • Gene-agnostic therapeutic approaches could potentially benefit patients across multiple IRD genotypes, expanding treatment opportunities beyond single-gene therapies

The Foundation Fighting Blindness and its venture philanthropy arm, the Retinal Degeneration (RD) Fund, have received a $1 million commitment from nonprofit organization "A Race Against Blindness" to support the development of gene-agnostic therapies for inherited retinal diseases (IRDs), according to an announcement from the Foundation.

The funding is intended to accelerate therapeutic approaches that could benefit patients regardless of the specific genetic mutation underlying their retinal disease, addressing one of the major challenges in the treatment of IRDs, which are associated with hundreds of different disease-causing genes.

Under the commitment, $775,000 will be directed to the RD Fund and matched dollar-for-dollar, effectively increasing the available capital for investments in promising retinal disease programs. The remaining $225,000 will support a Foundation Fighting Blindness research award focused on advancing gene-agnostic treatment strategies.

Gene-agnostic approaches have emerged as an area of growing interest in retinal research because they have the potential to treat broader patient populations than traditional gene replacement therapies, which are generally designed to target a single genetic mutation. Such approaches may include neuroprotective therapies, optogenetics, regenerative medicine strategies, and other technologies aimed at preserving or restoring vision independent of genotype.

The RD Fund, launched by the Foundation Fighting Blindness in 2018, operates as a nonprofit venture investment fund focused on advancing therapies for inherited retinal diseases and dry age-related macular degeneration. The organization seeks to bridge the funding gap between early-stage discoveries and clinical development through mission-related investments in emerging biotechnology companies.

A Race Against Blindness, founded by Stephen and Kristina Johnston following their family's experience with inherited retinal disease, has previously supported research programs targeting retinitis pigmentosa and Bardet-Biedl syndrome. The organization has raised and deployed millions of dollars toward retinal disease research and therapeutic development.

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Alcon Highlights Expanded Toric Lens Parameters and Dry Eye Innovation at AOA 2026 https://eyewire.news/news/alcon-to-highlight-expanded-toric-lens-parameters-and-dry-eye-innovation-at-aoa-2026 Thu, 18 Jun 2026 15:37:58 GMT https://eyewire.news/news/alcon-to-highlight-expanded-toric-lens-parameters-and-dry-eye-innovation-at-aoa-2026 Alcon showcased new contact lens and dry eye disease developments during the American Optometric Association (AOA) Meeting 2026, taking place June 17-20 in Phoenix, Arizona, with a focus on expanding fitting options for patients with astigmatism and advancing treatment approaches for dry eye disease.

The company announced expanded toric parameter availability across its Precision1, Precision7, and Total30 contact lens brands, extending astigmatism correction options across daily, weekly, and monthly replacement modalities. According to Alcon, the broader parameter ranges are intended to help eye care professionals fit a larger proportion of astigmatic patients while improving first-fit success and reducing the need for refits. Alcon said the expanded offerings are designed to provide practitioners with greater flexibility when managing a broader range of prescriptions and patient needs.

The company reported that, with the addition of expanded parameters for Total30 for Astigmatism, the portfolio will cover 99% of astigmatic eyes. Alcon also noted that Total30 for Astigmatism now offers the broadest readily accessible parameter availability among leading monthly replacement toric contact lens brands.

“In practice, a lack of parameter options can be a barrier to fitting some astigmatic patients in contact lenses,” said Torrey J. Carlson, OD, a multi-practice owner and founder of Dr. Torrey J. Carlson & Associates. “The expanded toric parameters will be instrumental in making it easier to find the right fit, streamline appointments, and ultimately help more patients fit in lenses.”

Alcon’s AOA presence will also feature educational programming related to Tryptyr (acoltremon ophthalmic solution) 0.003%, a TRPM8 receptor agonist indicated for the treatment of the signs and symptoms of dry eye disease. The therapy is designed to stimulate natural tear production through neuromodulation and represents a novel mechanism of action within the dry eye treatment landscape.

Attendees will have an opportunity to learn more about the science underlying the therapy, while Selina R. McGee, OD, and colleagues are scheduled to present findings from a proof-of-concept study evaluating lipid layer thickness in patients with evaporative dry eye disease.

In the contact lens category, Alcon will highlight continued adoption of Precision7, the company’s weekly replacement lens within its "WaterInnovations" portfolio. Introduced as a 1-week replacement option between daily disposable and monthly modalities, Precision7 incorporates the company’s Activ-Flo System, which combines embedded moisturizing agents with a replenishing agent designed to support lens surface hydration throughout the wear cycle.

In addition to product-focused activities, Alcon will host its "WaterInnovations Immersive Experience" at Booth #643. The interactive exhibit is designed to demonstrate the science behind the company’s contact lens technologies through visual and educational displays, with presentations scheduled throughout the meeting.

Attendees can also Alcon throughout AOA for educational sessions and sponsored events:

  • Thursday June 18th | Global Medical Affairs Breakfast Symposium, Room 132AB, 8am – 9am MST, with Marc R. Bloomenstein, OD, FAAO (Moderator); Ada Noh, OD; and Kaleb Abbott, OD, MS, FAAO, FOWNS
  • Thursday June 18th | Pharma Lunch Symposium, Room 132AB, 12pm – 1pm MST, with Dr. Josh Johnston, OD; Dr. Mila Ioussifova, OD; and Dr. Cory Lappin, OD
  • Friday June 19th | Keep the Connection, Grow the Convenience: MARLO Best Practices - Para Idea Exchange, Room 211 AB, 8am – 9:30am MST, with Cotie Suter, Practice Solutions, Alcon​+
  • Friday June 19th | CL OD Lunch Symposium: Say Yes to More Possibilities in ​Astigmatism Correction​, Room 132AB, 12pm – 1pm MST, with Dr. Melissa Barnett and Dr. Jason Compton ​

For more information on Alcon’s presence at Optometry’s Meeting 2026, including scientific presentations and on-site programming, visit www.myalcon.com/professional/events/alcon-at-aoa-2026/ or stop by Booth #617.

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Zeiss, Envision Health Technologies Collaborate to Advance VR-Based Glaucoma Testing https://eyewire.news/news/zeiss-envision-health-technologies-collaborate-to-advance-vr-based-glaucoma-testing Thu, 18 Jun 2026 13:44:08 GMT https://eyewire.news/news/zeiss-envision-health-technologies-collaborate-to-advance-vr-based-glaucoma-testing Key Takeaways

  • Zeiss and Envision Health Technologies have entered a strategic collaboration focused on advancing VR-based visual function testing for glaucoma care
  • The partnership combines Zeiss' expertise in perimetry with Envision's software-driven and virtual reality technologies to strengthen the clinical credibility of VR perimetry

Zeiss announced a strategic collaboration with Envision Health Technologies aimed at advancing glaucoma care through gamified virtual reality (VR) technology and software-driven visual function testing.

Financial terms of the deal were not disclosed. 

The collaboration aims to bring together Zeiss' expertise in perimetry and visual field testing with Envision Health Technologies' focus on digital eye health and VR-based diagnostic solutions. The companies said the initiative is intended to strengthen the scientific and clinical foundation of VR-based visual function assessment while supporting broader access to glaucoma screening and monitoring.

“As glaucoma care continues to evolve, clinicians are looking for solutions that improve patient accessibility, flexibility and experience without compromising clinical confidence,” said Anuj Kalra, head of chronic disease management at Zeiss Medical Technology. “Our collaboration with Envision Health Technologies reflects Zeiss’ commitment to advancing practical, clinician-driven innovation that can help expand access to visual function testing across a range of care settings.”

Envision Health Technologies was founded by glaucoma surgeon Lama A. Al-Aswad, MD, MPH, to develop data-driven technologies designed to improve outcomes for patients with vision-threatening diseases. The company has focused on creating software-based tools intended to transform how vision care is delivered, measured, and scaled.

“We believe the future of visual function testing should be more accessible, flexible, and patient-centered while remaining grounded in clinical rigor,” said Dr. Al-Aswad, who also serves as CEO of Envision Health. “Collaborating with Zeiss allows us to combine cutting-edge software innovation with decades of trusted market leadership in perimetry to help advance more practical solutions for real-world glaucoma care.”

According to the companies, the strategic collaboration will focus on helping shape the future direction of VR perimetry by integrating clinical expertise with emerging digital technologies. The effort is expected to support the development of clinically relevant testing solutions that maintain diagnostic confidence while improving patient experience and accessibility.

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The Myopia Collective Expands Network With New Change Agents, Launches Student Cohort https://eyewire.news/news/the-myopia-collective-expands-network-with-new-change-agents-launches-student-cohort Thu, 18 Jun 2026 13:38:46 GMT https://eyewire.news/news/the-myopia-collective-expands-network-with-new-change-agents-launches-student-cohort Key Takeaways

  • The Myopia Collective expanded its network by 49% with the addition of 22 new Change Agents and its first Student Change Agent cohort
  • The organization will host its inaugural Day of Advocacy on June 18, 2026, to raise awareness of childhood myopia and the value of early intervention

The Myopia Collective, an initiative founded by CooperVision and the American Optometric Association (AOA) to advance childhood myopia management as a standard of care, has expanded its leadership network with the addition of 22 new Change Agents and the launch of its first Student Change Agent cohort.

According to the organization, the additions represent a 49% expansion of the network and are intended to strengthen efforts to increase education, engagement, and adoption of evidence-based myopia management across the eye care community. The announcement coincides with the introduction of the collective's inaugural Day of Advocacy, a global awareness campaign scheduled for June 18, 2026. The social media–driven initiative aims to elevate public and professional awareness of childhood myopia and the importance of early intervention.

“The Day of Advocacy is a powerful opportunity to elevate and unite voices across the optometric community and beyond,” said Jennifer Palombi, OD, FAAO, director of professional affairs, Americas, at CooperVision. “By sharing personal experiences, clinical insights, and their passion for patient care, our community will ignite meaningful dialogue around myopia and inspire a greater understanding of its long-term impact. Together, we will reinforce the importance of early intervention and help build a future where protecting children’s vision is a shared priority across the profession and communities we serve.”

The Day of Advocacy will bring together Change Agents, Student Change Agents, partners, and advocates to share personal stories, clinical perspectives, and educational content using the hashtag #MyopiaAdvocacy2026. Organizers said the campaign is designed to create a unified global conversation focused on protecting children's long-term vision.

“We received an overwhelming level of interest from doctors and students eager to participate this year, and we are grateful to all who applied,” said Jacquie M. Bowen, OD, president of the AOA. “As we continue to grow this movement, we encourage everyone to become a Member of The Myopia Collective. Members receive updates and gain access to free educational opportunities, information, and resources to help the fight against childhood myopia.”

As part of their role, the newly selected Change Agents will attend a dedicated training workshop in November in Houston, Texas. The program is expected to provide practical guidance on implementing myopia management strategies in clinical practice while fostering collaboration among eye care professionals committed to advancing pediatric eye health.

The Myopia Collective was established to promote awareness, education, and adoption of myopia management approaches aimed at addressing the growing prevalence of childhood myopia. Additional information about membership, as well as a complete list of Change Agents and Student Change Agents, is available through the AOA.

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Ocular Therapeutix Aligns with FDA on Planned Axpaxli NDA Submission for Wet AMD https://eyewire.news/news/ocular-therapeutix-aligns-with-fda-on-planned-axpaxli-nda-submission-for-wet-amd Thu, 18 Jun 2026 13:30:26 GMT https://eyewire.news/news/ocular-therapeutix-aligns-with-fda-on-planned-axpaxli-nda-submission-for-wet-amd Key Takeaways

  • Ocular Therapeutix has aligned with the FDA on a planned fourth-quarter 2026 NDA submission for Axpaxli in wet AMD based on SOL-1 efficacy and safety data plus interim SOL-R safety results
  • The company is modifying the SOL-R trial to focus on long-term differentiation from aflibercept, including visual acuity superiority and retinal outcome assessments through Week 96
  • Ocular is also streamlining its diabetic retinopathy program, advancing a single global phase 3 study, HELIOS-3, evaluating once-yearly Axpaxli in non-proliferative diabetic retinopathy.

Ocular Therapeutix announced that it has reached alignment with the FDA on plans to submit a new drug application (NDA) for Axpaxli (also known as OTX-TKI) for the treatment of wet age-related macular degeneration (AMD) in the fourth quarter of 2026. The planned submission is expected to be based on efficacy and safety findings from the phase 3 SOL-1 trial together with interim safety data from the ongoing SOL-R study.

The company disclosed the regulatory update ahead of its Investor Day presentation, describing the FDA interaction as a key milestone in advancing Axpaxli toward potential commercialization. According to Ocular, the agency agreed that SOL-1 could serve as the pivotal efficacy study supporting the application, with additional confirmatory evidence and safety data included as part of the submission package.

“Our consistently strong execution has brought us to a pivotal milestone today,” said Pravin U. Dugel, MD, executive chairman, president, and CEO of Ocular Therapeutix, in a company statement. “We are thrilled to announce that we have FDA alignment on our plans to submit the Axpaxli NDA for wet AMD in the fourth quarter of 2026, based on SOL-1 efficacy and safety data, combined with interim safety data from SOL-R.”

The company reported that SOL-1 met its primary endpoint, demonstrating superiority on maintenance of vision at Week 36 with a P{-value of 0.0006. Ocular noted that the treatment effect strengthened over time and was supported by anatomical outcomes and statistically significant sensitivity analyses. The study was conducted under a Special Protocol Assessment agreement with the FDA.

Ocular plans to submit the NDA through the FDA’s 505(b)(2) pathway, which may allow for a more streamlined review process for modified versions or formulations of previously approved therapies. The company said the submission will include a broad package of confirmatory evidence, including mechanistic, pharmacodynamic, animal model, natural history, class-consistency, and real-world data.

To satisfy safety exposure requirements, Ocular intends to conduct an interim analysis of SOL-R in the fourth quarter of 2026. The combined safety database from SOL-1 and SOL-R is expected to exceed 300 patients with at least 1 year of treatment exposure, a benchmark the company cited as consistent with FDA expectations for neovascular AMD development programs.

SOL-R Modified to Support Long-Term Differentiation

With SOL-R efficacy data no longer expected to be part of the initial NDA review package, Ocular is revising the trial to focus on longer-term differentiation from aflibercept. The company said it plans to maintain masking through Week 96 and add new secondary endpoints, including an assessment of superiority in best-corrected visual acuity compared with aflibercept 8 mg. Investigators will also evaluate fibrosis and atrophy outcomes relative to aflibercept 2 mg. Topline results from SOL-R are now anticipated in the first quarter of 2028.

“SOL-1 trial results potentially meet this high bar of a single trial approval with the combined data from the planned SOL-R interim analysis providing the required greater than 300 patients for the safety dataset,” said Arshad M. Khanani, MD, MA, FASRS, director of clinical research at Sierra Eye Associates and steering committee chair for the SOL program.

Diabetic Retinopathy Program Streamlined

In a separate development, Ocular announced plans to streamline its diabetic retinopathy development strategy by prioritizing a single global phase 3 registrational study, HELIOS-3. The trial will evaluate once-yearly Axpaxli against sham treatment in patients with non-proliferative diabetic retinopathy. The primary endpoint will assess a two-step or greater improvement in diabetic retinopathy severity score at Week 56.

The company said the revised strategy is intended to support global regulatory objectives while capitalizing on physician interest in a once-yearly treatment paradigm for diabetic retinal disease.

If approved, Ocular expects Axpaxli could reach the market in 2027 and potentially offer a longer-duration treatment option for patients with wet AMD.

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Ocumension Receives Positive Chinese Regulatory Feedback for NCX 470 Ahead of Marketing Submission https://eyewire.news/news/ocumension-receives-positive-chinese-regulatory-feedback-for-ncx-470-ahead-of-marketing-submission Thu, 18 Jun 2026 13:16:54 GMT https://eyewire.news/news/ocumension-receives-positive-chinese-regulatory-feedback-for-ncx-470-ahead-of-marketing-submission Key Takeaways

  • Ocumension Therapeutics received positive pre-submission feedback from China’s Center for Drug Evaluation for NCX 470, supporting advancement toward a marketing application filing
  • The regulatory update follows a successful pre-NDA meeting with the FDA and positions the program for near-term submissions in both the United States and China

Nicox announced that its exclusive China licensee, Ocumension Therapeutics, has received positive pre-submission regulatory feedback from the Chinese Center for Drug Evaluation (CDE) for NCX 470, a nitric oxide-donating bimatoprost eye drop under development for lowering IOP in patients with open-angle glaucoma or ocular hypertension.

According to Nicox, Ocumension believes the feedback is sufficient to support submission of the marketing application dossier for NCX 470 to the Chinese National Institutes for Food and Drug Control. The update follows a recently completed pre–new drug application (NDA) meeting with the US FDA that Nicox previously described as successful.

“We congratulate our colleagues at Ocumension for the progress made on NCX 470 in China,” Doug Hubatsch, chief scientific officer of Nicox, said in a company statement. “This positive interaction with the Chinese Center for Drug Evaluation follows the recently announced successful NCX 470 pre-new drug application meeting with the U.S. FDA. With these two outcomes in hand, we are confident the respective submissions can be achieved shortly.”

Hubatsch added that Nicox expects its exclusive US partner, Kowa, to submit the NDA for NCX 470 in the United States during the summer of 2026, with the Chinese submission anticipated shortly thereafter.

NCX 470 (bimatoprost grenod) combines bimatoprost with a nitric oxide–donating moiety and is being developed as a treatment to reduce IOP in patients with open-angle glaucoma or ocular hypertension. Elevated IOP remains the primary modifiable risk factor for glaucoma progression.

Under existing licensing agreements, Kowa holds global rights to NCX 470 outside of China, South Korea, and Southeast Asia, while Ocumension holds rights in those Asian territories. Nicox is eligible to receive regulatory and commercial milestone payments as well as royalties on worldwide sales. Development, regulatory, and commercialization expenses are being funded by Kowa and Ocumension under their respective agreements.

The company also highlighted ongoing development activities in Japan, where a phase 3 clinical program for NCX 470 was initiated in the summer of 2025.

Upcoming Milestones

  • NDA submission for NCX 470 in the United States: expected summer 2026
  • NDA submission for NCX 470 in China: expected shortly after the US filing
  • Ongoing phase 3 clinical development program in Japan, initiated in summer 2025
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Zeiss, Aier Eye Hospital Group Plan Global Deployment of Visumax 800 Systems https://eyewire.news/news/zeiss-aier-eye-hospital-group-expand-partnership-with-planned-deployment-of-25-visumax-800-systems Wed, 17 Jun 2026 18:11:12 GMT https://eyewire.news/news/zeiss-aier-eye-hospital-group-expand-partnership-with-planned-deployment-of-25-visumax-800-systems Zeiss and Aier Eye Hospital Group have entered into a strategic agreement for the purchase and installation of 25 Visumax 800 femtosecond laser systems, expanding their collaboration in refractive surgery and ophthalmic care.

The agreement was formalized during a signing ceremony held June 12 at Aier Eye Hospital Group's headquarters in Changsha, Hunan Province, China. Under the terms of the agreement, the Visumax 800 systems will be deployed across Aier's domestic and international hospital network beginning later in 2026. According to the companies, the partnership is intended to support the delivery of advanced refractive surgery technologies and enhance patient care through innovation, digital integration, and expanded clinical capabilities.

“Aier Eye Hospital is one of Zeiss Medical Technology’s most important global strategic partners,” said Martin Fischer, president and CEO of Zeiss Greater China. “In the future, the two parties will explore deeper collaborative innovation in areas such as international expansion, integrated digital workflows and platforms, and AI-assisted diagnosis.”

The Visumax 800 platform supports Smile pro, a minimally invasive refractive procedure designed to treat myopia and myopic astigmatism. The latest agreement expands the installed base of the technology within Aier's global network and reflects continued investment in refractive surgery infrastructure.

“Our collaboration with Zeiss has long transcended mere equipment procurement,” said Li Li, co-founder and global president of Aier Eye Hospital Group. “We are jointly exploring comprehensive synergies spanning from clinical management to digital applications. The introduction of 25 Visumax 800 systems will help Aier further enhance surgical efficiency and patient satisfaction, aiming to set a new quality benchmark for refractive surgery worldwide.”

According to Zeiss, Aier is expected to become the ophthalmic institution with the largest installed base of Visumax 800 systems globally following deployment of the new units. The company also recognized Aier for having the largest number of Smile pro-certified surgeons worldwide and for performing the highest volume of Smile pro procedures in China.

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Alcon Marks 30 Years of WaveLight Innovation at Pressath, Germany Facility https://eyewire.news/news/alcon-marks-30-years-of-wavelight-innovation-at-pressath-germany-facility Wed, 17 Jun 2026 16:42:27 GMT https://eyewire.news/news/alcon-marks-30-years-of-wavelight-innovation-at-pressath-germany-facility Key Takeaways

  • Alcon celebrated the 30th anniversary of its WaveLight manufacturing and R&D facility in Pressath, Germany, highlighting its role in global refractive surgery innovation
  • The company showcased WaveLight Plus, a personalized LASIK platform that uses ray-tracing technology to customize treatment based on each patient’s optical system

Alcon is commemorating the 30th anniversary of its WaveLight manufacturing and research-and-development facility in Pressath, Germany, highlighting three decades of refractive surgery innovation and ongoing investment in laser vision correction technologies.

The anniversary celebration showcased technologies developed and manufactured across Alcon’s German operations, including WaveLight Plus, a personalized laser vision correction platform designed to tailor LASIK treatment to an individual patient’s optical characteristics and visual needs. According to the company, the technology uses ray-tracing-based treatment planning to create customized ablation profiles that account for each patient’s unique optical system.

The Pressath facility, along with WaveLight sites in Erlangen and Teltow, Germany, supports the development and production of WaveLight refractive surgery platforms used globally. Alcon said the facilities play a central role in manufacturing technologies that support excimer laser procedures and personalized LASIK treatments.

“For 30 years, our WaveLight facilities in Germany have been at the heart of advancing innovation in refractive surgery, bringing together high-performance engineering, manufacturing and R&D excellence, and a passion for improving sight,” said Jason Mangum, vice president of global manufacturing and technical operations, surgical, at Alcon, in a company statement. “This milestone reflects the dedication of our teams and underscores Alcon’s commitment to helping people see brilliantly.”

The company said the anniversary reflects both the heritage of the Pressath facility and continued investments intended to maintain the competitiveness of its German manufacturing and development network.

“We are proud to operate in Germany—first in Erlangen, and now in Pressath and Teltow,” said Thomas O’Neil, vice president and WaveLight site head at Alcon. “Thanks to the strong commitment of our teams in Germany, we are able to successfully advance WaveLight technologies on a global scale. We remain focused on delivering sight-correcting innovations and supporting the next generation of technologies that will help shape the future of eye care.”

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Thea Announces US Launch of Glaucoma Treatment Zolymbus https://eyewire.news/news/thea-announces-us-launch-of-zolymbus-for-glaucoma-management Wed, 17 Jun 2026 15:35:23 GMT https://eyewire.news/news/thea-announces-us-launch-of-zolymbus-for-glaucoma-management Thea US has announced the upcoming US launch of Zolymbus (bimatoprost ophthalmic gel 0.01%), a preservative-free gel formulation developed for the management of glaucoma.

Zolymbus is a preservative-free gel formulation which is a prostaglandin analog indicated for the reduction of elevated IOP in patients with open-angle glaucoma or ocular hypertensionis. Designed and developed with a focus on efficacy, tolerability, safety, and convenience, Zolymbus aims to support long-term treatment adherence while addressing the needs of both patients and eye care professionals.

“With the launch of Zolymbus, we are introducing more than a new treatment option—we are delivering an innovative solution designed to improve the experience of glaucoma management for both patients and providers,” said Rob Shilton, head of marketing at Thea US, in a company statement. “This launch reflects our continued commitment to advancing ophthalmic care through meaningful innovation and patient-focused therapies.”

The company stated that Zolymbus will be supported by product availability and patient access initiatives as it enters the US market. 

“Our team is energized by the opportunity ahead,” Mr. Shilton said. “Through strong partnerships with eye care professionals and a continued focus on clinical excellence, we believe Zolymbus has the potential to make a meaningful impact in glaucoma care across the United States.”

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WCO, Alcon Update Dry Eye Wheel with TFOS DEWS III Recommendations https://eyewire.news/news/wco-alcon-update-dry-eye-wheel-with-tfos-dews-iii-recommendations Wed, 17 Jun 2026 12:36:29 GMT https://eyewire.news/news/wco-alcon-update-dry-eye-wheel-with-tfos-dews-iii-recommendations Key Takeaways

  • WCO and Alcon have updated the WCO Alcon Dry Eye Wheel to align with recommendations from the TFOS DEWS III report
  • New features include dry eye etiological drivers, the OSDI-6 questionnaire, and expanded management guidance
  • The updated wheel, management map, and educational resources are available free of charge in multiple languages to support global dry eye disease care

The World Council of Optometry (WCO) and Alcon have launched an updated version of the WCO Alcon Dry Eye Wheel, incorporating the latest recommendations from the recently published Tear Film & Ocular Surface Society Dry Eye Workshop III (TFOS DEWS III) report.

The no-cost clinical resource is designed to help eye care professionals (ECPs) support patients with dry eye disease through three key steps: mitigation, measurement, and management. The interactive tool is available online and is intended to provide practitioners with current, evidence-based guidance for dry eye diagnosis and treatment.

According to WCO, the updated wheel includes several enhancements based on TFOS DEWS III recommendations, including the addition of dry eye etiological drivers, integration of the OSDI-6 symptomatology questionnaire, and new and refined management options.

“Clinicians and educators who use the WCO Alcon Dry Eye Wheel as part of their daily practice can be assured that it reflects the most current consensus recommendations from the world’s top experts,” said Cindy Tromans, BSc (Hons), PhD, FEAOO, president of WCO.

The revised wheel complements the WCO Alcon Dry Eye Management Map, an interactive online resource developed to assist ECPs in navigating dry eye disease management. Both tools are available in multiple languages, including Arabic, Chinese, French, and Spanish, with additional language support planned.

The broader WCO-Alcon dry eye initiative website has also been expanded to include a three-part educational video series designed to help practitioners better understand the TFOS DEWS III report. The series provides an overview of the report, reviews diagnostic methodologies, and highlights recommendations related to management and therapy.

While the tools are intended to support clinical decision-making, WCO emphasized that optometrists retain full medical judgment and responsibility for determining the most appropriate course of care for individual patients. Additional information about the initiative and educational resources is available through the WCO-Alcon dry eye program website.

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Bayer Completes Acquisition of Perfuse Therapeutics, Gains Full Rights to PER-001 https://eyewire.news/news/bayer-completes-acquisition-of-perfuse-therapeutics-gains-full-rights-to-per-001 Wed, 17 Jun 2026 12:29:01 GMT https://eyewire.news/news/bayer-completes-acquisition-of-perfuse-therapeutics-gains-full-rights-to-per-001 Key Takeaways

  • Bayer has completed its acquisition of Perfuse Therapeutics and will fully integrate the company into its operations
  • The deal gives Bayer full rights to PER-001, a phase 2 intravitreal implant being developed for glaucoma and diabetic retinopathy
  • Bayer paid $300 million upfront, with the transaction carrying a potential total value of up to $2.45 billion through milestone payments

Bayer has completed its acquisition of Perfuse Therapeutics, bringing the ophthalmology-focused biotechnology company fully into Bayer’s organization and securing full rights to PER-001, an investigational intravitreal implant currently in phase 2 clinical development for glaucoma and diabetic retinopathy (DR).

In May, Bayer has entered into an agreement to acquire Perfuse. Under the terms of the agreement, the transaction carries a total potential value of up to $2.45 billion, including a $300 million upfront payment and additional development, regulatory, and commercial milestone payments tied to the achievement of specified success criteria.

PER-001 is being investigated as a potential neuroprotective therapy designed to address the underlying ischemic and inflammatory mechanisms associated with glaucoma, unlike currently approved therapies that primarily focus on lowering IOP. PER-001 is an investigational endothelin receptor antagonist targeting endothelin, one of the body’s most potent vasoconstrictors. Elevated endothelin activity has been implicated in several retinal diseases. According to Perfuse, endothelin contributes to inflammation and cell death through receptors found in retinal vascular and neuroretinal cells.

The therapy is delivered through a bio-erodible intravitreal implant administered using a single-use, 25-gauge applicator. The implant is designed to provide sustained release of PER-001, potentially enabling a more convenient dosing regimen for patients.

The transaction marks an expansion of Bayer’s ophthalmology portfolio. Bayer holds the exclusive marketing rights to Eylea 2 mg and Eylea 8 mg (marketed as Eylea HD in the United States) outside of the US. The new deal positions the company to potentially bring forward one of the first treatments aimed at improving visual field outcomes in glaucoma patients and enhancing contrast sensitivity while reducing ischemia in diabetic retinopathy patients.

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Johnson & Johnson Expands Acuvue Oasys 1-Day for Astigmatism Parameter Range to -2.75D Cylinder https://eyewire.news/news/johnson-johnson-expands-acuvue-oasys-1-day-for-astigmatism-parameter-range-to-275d-cylinder Tue, 16 Jun 2026 16:52:53 GMT https://eyewire.news/news/johnson-johnson-expands-acuvue-oasys-1-day-for-astigmatism-parameter-range-to-275d-cylinder Key Takeaways

  • Johnson & Johnson expanded Acuvue Oasys 1-Day for Astigmatism parameters up to -2.75D cylinder, with U.S. and Canadian availability expected this summer
  • The expanded portfolio includes 3,350 parameter combinations, allowing eye care professionals to fit a broader range of patients with astigmatism

At the 129th Annual AOA Congress: Optometry’s Meeting, Johnson & Johnson announced an expansion of the parameter range for its Acuvue Oasys 1-Day for Astigmatism daily disposable contact lens, extending cylinder powers up to -2.75D. The expanded portfolio is expected to become available in the United States and Canada this summer.

According to J&J, the broader parameter range is designed to help eye care professionals fit a larger proportion of patients with astigmatism using daily disposable toric lenses. The expanded offering will include 3,350 parameter combinations.

Johnson & Johnson said Acuvue Oasys 1-Day for Astigmatism utilizes its Blink Stabilized Design technology, which incorporates four stability zones and a prism-free optic zone. The design is intended to help the lens quickly orient and remain stable on the eye, providing clear and consistent vision throughout the day.

“Expanding Acuvue Oasys 1-Day for Astigmatism parameters is an important step in addressing the needs of people with astigmatism, which represents nearly half of all patients,” said Shawn Millerick, president, Americas, Vision, Johnson & Johnson, in a company announcement. “By broadening parameter availability, we’re enabling eye care professionals to fit more patients with daily contact lenses to enjoy excellent comfort and clear, stable vision throughout the day.”

The announcement follows several recent additions to the Acuvue contact lens portfolio aimed at expanding fitting options for patients with astigmatism. Earlier this year, Johnson & Johnson expanded the parameter range of Acuvue Vita for Astigmatism, its monthly replacement toric lens. The company said the updated range allows practitioners to fit nearly 96% of astigmatic patients and provides axis availability in 10-degree increments up to -2.75D cylinder.

The latest expansion also builds on the launch of Acuvue Oasys Max 1-Day for Astigmatism and Acuvue Oasys Max 1-Day Multifocal for Astigmatism, introduced last year. Johnson & Johnson describes the Acuvue Oasys Max 1-Day family as the first complete daily disposable contact lens family to include options for astigmatism and multifocal astigmatism correction.

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Emmecell Secures Strategic Financing Round With Participation From Bausch + Lomb https://eyewire.news/news/emmecell-secures-strategic-financing-round-with-participation-from-bausch-lomb Tue, 16 Jun 2026 13:11:54 GMT https://eyewire.news/news/emmecell-secures-strategic-financing-round-with-participation-from-bausch-lomb Key Takeaways

  • Emmecell completed a strategic financing round that included participation from existing investors and Bausch + Lomb
  • Funding will support advancement of the company's clinical programs and continued development of its magnetic cell delivery platform
  • The technology is designed to improve the precision and effectiveness of ocular cell therapies, particularly for corneal endothelial disease

Emmecell, a clinical-stage biotechnology company developing magnetic cell delivery technologies for ophthalmic diseases, has closed a strategic financing round that included participation from existing investors and Bausch + Lomb, according to a company announcement. Specific terms of the financing were not disclosed.

The company said proceeds from the financing will be used to advance its clinical programs, expand operational capabilities, and further develop its proprietary magnetic cell delivery platform.

According to Emmecell. interest continues to grow in regenerative medicine approaches for corneal disease, particularly therapies aimed at reducing dependence on donor tissue and invasive surgical procedures. Corneal endothelial disease, including Fuchs' endothelial corneal dystrophy and endothelial cell loss associated with trauma or surgery, affects millions of patients globally and remains a leading cause of vision impairment. Although corneal transplantation is currently the standard treatment for advanced disease, limitations related to donor tissue availability and surgical risks have fueled the search for alternative therapeutic approaches.

Emmecell's technology is designed to deliver therapeutic cells to diseased ocular tissues using magnetic guidance. According to the company, the platform aims to improve cell localization, retention, and engraftment—key challenges that have historically limited the effectiveness of cell-based therapies. By enabling more precise positioning of therapeutic cells within the eye, the company believes the platform could improve treatment outcomes and broaden the application of cell therapies across ophthalmic indications.

"This financing marks an important milestone for Emmecell as we continue advancing our magnetic cell delivery platform and clinical programs," said Ramin Valian, CEO of Emmecell. "We are grateful for the support of both new and existing investors as we work to develop innovative treatment options for patients with serious ophthalmic diseases."

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Alcon Launches Unity Cataract System in Canada https://eyewire.news/news/alcon-launches-unity-cataract-system-in-canada Tue, 16 Jun 2026 12:47:40 GMT https://eyewire.news/news/alcon-launches-unity-cataract-system-in-canada Key Takeaways

  • Alcon has launched the Unity Cataract System (CS) in Canada, expanding the company’s next-generation surgical platform ahead of COS 2026 in Montréal
  • The standalone cataract platform is designed to improve surgical efficiency, featuring a phacoemulsification modality that delivers up to two times faster nucleus removal with 40% less energy into the eye

Alcon announced the Canadian launch and availability of the Unity Cataract System (CS), the company’s next-generation standalone cataract surgical platform, ahead of the Canadian Ophthalmological Society (COS) Annual Meeting and Exhibition, taking place June 18–21, 2026, in Montréal.

According to Alcon, the Unity platform has supported more than 285,000 procedures globally across approximately 1,350 systems worldwide. The platform includes both the Unity Cataract System (CS), dedicated exclusively to cataract surgery, and the Unity Vitreoretinal Cataract System (VCS), which supports both cataract and vitreoretinal procedures on a single integrated platform.

“COS 2026 marks an exciting milestone for Alcon as we continue advancing the next generation of surgical innovation in Canada,” said Mark Newson, Country Manager and Head of Surgical, Alcon Canada. “With Unity CS, we are bringing forward technology designed to help surgeons and surgical teams operate with greater efficiency, consistency, and confidence in cataract surgery while supporting a smoother workflow in the operating room.”

The company said Unity CS incorporates a novel phacoemulsification modality engineered to provide up to two times faster nucleus removal while delivering 40% less energy into the eye. The platform also features what Alcon describes as a first-of-its-kind phaco handpiece capable of estimating temperature at the incision site, a feature intended to enhance intraoperative awareness and control.

The Canadian introduction of Unity CS comes amid a broader series of product launches from Alcon in 2026. Recent additions to the company’s portfolio include Unity VCS, PanOptix Pro, and the Valeda photobiomodulation (PBM) device, indicated for the treatment of early and intermediate dry age-related macular degeneration (AMD).

Both Unity VCS and Unity CS are part of the Alcon Vision Suite, the company’s portfolio of products designed to help eye care professionals improve efficiency in both clinical and surgical settings.

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The Myopia Collective Expands Network with New Change Agents, Launches Inaugural Student Cohort https://eyewire.news/news/the-myopia-collective-expands-network-with-new-change-agents-launches-inaugural-student-cohort Tue, 16 Jun 2026 12:30:05 GMT https://eyewire.news/news/the-myopia-collective-expands-network-with-new-change-agents-launches-inaugural-student-cohort Key Takeaways

  • The Myopia Collective has expanded its network by 49% with the addition of 22 new Change Agents and its inaugural Student Change Agent cohort
  • The organization will host its first Day of Advocacy on June 18, 2026, uniting eye care professionals, students, and advocates worldwide to raise awareness of childhood myopia through the social media campaign #MyopiaAdvocacy2026.

The Myopia Collective, an initiative founded by CooperVision and the American Optometric Association (AOA) to advance childhood myopia management as a standard of care, announced the addition of 22 new "Change Agents" and the launch of its first-ever Student Change Agent cohort.

The additions represent a 49% expansion of the organization's network of advocates and leaders dedicated to increasing education, engagement, and adoption of evidence-based myopia management across the eye care profession. 

“We received an overwhelming level of interest from doctors and students eager to participate this year, and we are grateful to all who applied,” said Jacquie M. Bowen, OD, President of the American Optometric Association. “As we continue to grow this movement, we encourage everyone to become a member of The Myopia Collective. Members receive updates and gain access to free educational opportunities, information, and resources to help the fight against childhood myopia.”

The Myopia Collective was established to help accelerate awareness and adoption of myopia management strategies as rates of childhood myopia continue to rise globally. Through education, advocacy, and professional collaboration, the initiative seeks to equip eye care professionals with resources to support earlier intervention and improved long-term visual outcomes for children.

As part of their role, newly selected Change Agents will participate in a dedicated training workshop in November in Houston, Texas. The program will provide practical guidance and peer collaboration opportunities designed to strengthen myopia management implementation in clinical practice while advancing children's eye health.

In addition to expanding its leadership network, The Myopia Collective announced plans for its first Day of Advocacy, scheduled for June 18, 2026. The global social media initiative is intended to raise awareness of childhood myopia and highlight the importance of early intervention. The campaign will bring together Change Agents, Student Change Agents, industry partners, and advocates worldwide to share personal experiences, clinical perspectives, and educational insights using the hashtag #MyopiaAdvocacy2026. Organizers hope the effort will spark a broader conversation about the long-term impact of myopia and the importance of proactive management.

“The Day of Advocacy is a powerful opportunity to elevate and unite voices across the optometric community and beyond,” said Jennifer Palombi, OD, FAAO, Director of Professional Affairs, Americas, CooperVision. “By sharing personal experiences, clinical insights, and their passion for patient care, our community will ignite meaningful dialogue around myopia and inspire a greater understanding of its long-term impact. Together, we will reinforce the importance of early intervention and help build a future where protecting children’s vision is a shared priority across the profession and communities we serve.”

For additional information about The Myopia Collective, membership opportunities, and the full list of Change Agents and Student Change Agents, visit AOA.org.

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Saptalis Launches Cyclosporine Ophthalmic Emulsion 0.05%; Expands Portfolio Across Multiple Therapeutic Areas https://eyewire.news/news/saptalis-launches-cyclosporine-ophthalmic-emulsion-005-expands-portfolio-across-multiple-therapeutic-areas Mon, 15 Jun 2026 19:41:39 GMT https://eyewire.news/news/saptalis-launches-cyclosporine-ophthalmic-emulsion-005-expands-portfolio-across-multiple-therapeutic-areas Saptalis Pharmaceuticals announced the commercial launch of cyclosporine ophthalmic emulsion 0.05%, a generic version of Restasis (Abbvie), for the treatment of dry eye disease.

The preservative-free, single-use formulation, which is available in 30-count and 60-count single-use vials, is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca.

In addition to the ophthalmic launch, Saptalis announced the approval and commercialization of several new products spanning autoimmune disorders, psychiatry, dermatology, and allergy-related conditions:

  • Tofacitinib Oral Solution, 1 mg/mL (240 mL), indicated for the treatment of autoimmune and inflammatory conditions, including rheumatoid arthritis and related disorders.
  • Hydroxyzine HCl Oral Solution, USP 10 mg/5 mL (473 mL), indicated for the symptomatic relief of anxiety and tension, as well as the management of pruritus associated with allergic conditions.
  • Chlorpromazine HCl Oral Concentrate, 30 mg/mL (120 mL) and 100 mg/mL (240 mL), indicated for the treatment of schizophrenia and other psychotic disorders and for the control of severe nausea and vomiting.
  • Desoximetasone Cream, USP 0.05% and 0.25% (15 g and 60 g), indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
  • Fluocinonide Topical Solution, USP 0.05% (20 mL and 60 mL), indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive scalp and skin conditions.

All products are available by prescription. For full prescribing information, visit www.saptalis.com.

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Johnson & Johnson Invests More Than $1 Billion to Expand Vision Manufacturing Operations in Jacksonville https://eyewire.news/news/johnson-johnson-invests-more-than-1-billion-to-expand-vision-manufacturing-operations-in-jacksonville Mon, 15 Jun 2026 17:43:24 GMT https://eyewire.news/news/johnson-johnson-invests-more-than-1-billion-to-expand-vision-manufacturing-operations-in-jacksonville Key Takeaways

  • Johnson & Johnson is investing more than $1 billion in Jacksonville, Florida, to expand U.S.-based manufacturing, packaging and distribution capabilities for its Acuvue contact lens business
  • The project includes a new state-of-the-art distribution facility and advanced manufacturing technologies designed to increase production capacity and meet global demand for Acuvue contact lenses, with operations expected to be fully online by 2028

Johnson & Johnson announced plans to invest more than $1 billion in its vision business operations in Jacksonville, Florida, a move aimed at expanding US-based manufacturing, packaging and distribution capabilities for its Acuvue contact lens portfolio.

The investment will fund construction of a new distribution facility and deployment of advanced manufacturing and packaging technologies designed to increase production capacity and support growing global demand for Acuvue contact lenses. The company said the expansion will further strengthen its ability to deliver eye health products to more than 40 million patients worldwide.

“This investment reinforces our long-standing conviction that advanced manufacturing in the United States is essential to delivering innovative, high-quality healthcare solutions to patients at home and around the world,” said Joaquin Duato, chairman and chief executive officer of Johnson & Johnson. “By further strengthening our Vision operations in Jacksonville with next-generation manufacturing, packaging and distribution capabilities, we are enhancing the resilience of our U.S. supply chain while helping more people see better and live better.”

The Jacksonville investment is part of Johnson & Johnson’s previously announced $55 billion commitment to US manufacturing, research and development, and technology through early 2029. Construction is already underway, with the new facility expected to become fully operational in 2028. 

Johnson & Johnson Vision has maintained a presence in Jacksonville since 1981 and today operates more than 1.5 million square feet of manufacturing, research, distribution and operations facilities in the region. The company currently manufactures more than 1.7 billion Acuvue contact lenses annually for the US market from its Jacksonville operations. The latest investment is expected to support continued growth of the Jacksonville campus while strengthening opportunities for the approximately 3,500 employees working in the area.

Johnson & Johnson said the Jacksonville project will enhance its ability to scale manufacturing and distribution operations while maintaining quality standards across its Acuvue portfolio. The company noted that the investment reflects its broader strategy of strengthening domestic manufacturing capabilities while supporting innovation in eye health.

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Ethyreal Bio Presents Preclinical Data Supporting Clinical Advancement of ETHY-001 for Thyroid Eye Disease https://eyewire.news/news/ethyreal-bio-presents-preclinical-data-supporting-clinical-advancement-of-ethy-001-for-thyroid-eye-disease Mon, 15 Jun 2026 13:47:36 GMT https://eyewire.news/news/ethyreal-bio-presents-preclinical-data-supporting-clinical-advancement-of-ethy-001-for-thyroid-eye-disease Key Takeaways

  • ETHY-001 completely blocked autoantibody-driven TSHR activation in all 34 moderate-to-severe thyroid eye disease patient serum samples tested, supporting TSHR as a promising therapeutic target for both TED and Graves' disease
  • Ethyreal Bio plans to initiate a first-in-human clinical trial of ETHY-001 in the second half of 2026

Ethyreal Bio presented preclinical data supporting its lead candidate, ETHY-001, during an oral presentation at the Endocrine Society's Annual Meeting (ENDO 2026).

ETHY-001 is an internally discovered, half-life-extended monoclonal antibody designed to block autoantibody-mediated activation of the thyroid stimulating hormone receptor (TSHR), the shared pathogenic driver of both thyroid eye disease (TED) and Graves' disease (GD). The company believes the therapy has the potential to become a differentiated, single-agent treatment for both conditions.

The presentation highlighted data demonstrating potent and highly specific binding to TSHR, complete blockade of disease-driving receptor activation across patient samples, and differentiated activity compared with insulin-like growth factor-1 receptor (IGF-1R) antagonism in preclinical TED models.

"The data presented today underscore the promise of ETHY-001 for the treatment of TED and GD," said Niranjan Kameswaran, PhD, Chief Executive Officer of Ethyreal Bio. "The depth and consistency of signaling blockade across all tested patient sera samples, combined with its differentiated activity compared to IGF-1R antagonism in TED models, reinforce our conviction in ETHY-001's product profile. We believe that ETHY-001's unique combination of potent receptor blockade, subcutaneous administration, and extended half-life has the potential to support a best-in-class, convenient, single-agent approach for both conditions. We are excited to advance ETHY-001 into the clinic this year."

Among the key findings presented, ETHY-001 demonstrated sub-nanomolar monovalent affinity for TSHR with no detectable off-target binding in a membrane protein array evaluating more than 5,000 membrane proteins. The antibody also produced complete inhibition of autoantibody-driven TSHR activation in all 34 moderate-to-severe TED patient serum samples evaluated to date, suggesting broad activity against the pathogenic antibodies that drive disease progression.

Additional studies in primary orbital fibroblasts derived from TED patients showed ETHY-001 completely inhibited secretion of both hyaluronan (HA) and interleukin-6 (IL-6) following stimulation with M22, a potent TSHR-stimulating antibody. By comparison, an IGF-1R antagonist comparator inhibited HA secretion but did not suppress IL-6 secretion, highlighting what the company described as potentially broader inhibition of disease-relevant signaling pathways through direct TSHR blockade.

Ethyreal said the collective data support advancement of ETHY-001 into clinical development for both TED and GD. The company plans to initiate a first-in-human clinical trial in the second half of 2026 to evaluate the therapy's safety, tolerability, pharmacokinetics, and pharmacodynamics.

Presentation Details

  • Title: “ETHY-001, a Half-Life Extended, TSHR Monoclonal Antibody Antagonist, Potently Inhibits TSHR Activation Induced by Patient Sera and M22-Induced Hyaluronan and IL-6 Secretion from TED Patient-Derived Orbital Fibroblasts”
  • Authors: Lauren Pepper, Phillip Truong, Elisa Roztocil, Gina-Eva Görtz, Mareike Horstmann, Jasvinder Paul Banga, Collyn Woeller, Anja Eckstein, Stephen Huang, Kelly Foster
  • Presenter: Kelly Foster, Ph.D., SVP, Translational Medicine, Ethyreal Bio
  • Date: Monday, June 15, 2026
  • Time / Session: 1:45 PM – 3:15 PM CT / “See through TED”
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BVI Opens Experience Hub in Spain to Expand Ophthalmic Surgical Education and Collaboration https://eyewire.news/news/bvi-opens-experience-hub-in-spain-to-expand-ophthalmic-surgical-education-and-collaboration Mon, 15 Jun 2026 13:27:59 GMT https://eyewire.news/news/bvi-opens-experience-hub-in-spain-to-expand-ophthalmic-surgical-education-and-collaboration Key Takeaways

  • New facility expands opportunities for hands-on learning, professional development, and clinical collaboration
  • BVI plans to expand the Hub's educational offerings through structured programs covering cataract surgery, glaucoma and vitreoretinal procedures, premium intraocular lenses, and practice development

BVI has announced the opening of the BVI Experience Hub, a dedicated facility designed to support ophthalmic training, professional development, and clinical collaboration for surgeons and clinical teams from Europe and around the world.

Located within BVI Iberia's offices in Sant Cugat, Spain, the Experience Hub combines hands-on wetlab facilities with collaborative learning spaces to provide immersive educational experiences. The center includes a dedicated auditorium, breakout rooms for group learning, and a realistic mock operating theater designed for workflow optimization studies, usability testing, and demonstrations of emerging ophthalmic technologies.

The facility is intended to support a broad range of educational activities, including surgical training programs, lectures, workshops, advisory board meetings, and collaborative learning initiatives. Its launch reflects a wider trend across healthcare toward continuous professional education and practical skills development as new technologies, techniques, and treatment options continue to reshape clinical and surgical practice.

To support realistic cataract and vitreoretinal training, the Experience Hub is equipped with phaco and dual-function Virtuoso systems, LEOS ECP/endoscopy technology, surgical microscopes, and diagnostic equipment. The center will also serve as a physical extension of BVI's growing educational ecosystem, complementing digital learning resources with hands-on training and peer-to-peer engagement.

"The Experience Hub is an important milestone for BVI and the first facility of its kind for our company," said Andy Chang, Chief Commercial Officer of BVI. "It reflects our commitment to supporting surgeons, customers, and teams around the world through education, collaboration, and practical learning. The Hub creates a place where technology, expertise, and partnership come together, bringing clinicians and industry together to exchange knowledge, develop skills, and ultimately help improve vision for patients worldwide."

BVI said the facility will play an important role in supporting surgeon engagement and product evaluation as ophthalmic technologies continue to evolve.

"As surgical technologies continue to evolve, education plays an increasingly important role in helping clinicians evaluate, adopt, and refine new techniques," said Mikhail Boukhny, Chief Technology Officer of BVI. "The Experience Hub creates opportunities not only for practical learning and collaboration, but also for meaningful engagement between surgeons and our teams. By bringing education, discussion, product evaluation, and hands-on experience together in one environment, we can better understand user needs, gather valuable feedback, and support the development of technologies that address real-world clinical challenges."

Looking ahead, BVI plans to expand the Hub's educational offerings through structured programs and courses led by internationally recognized ophthalmic surgeons. The company also intends to support collaboration with academic institutions, residency programs, and selected ophthalmic industry partners.

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Genetic Analysis Links Aspirin Use to Increased Risk of Early and Dry AMD https://eyewire.news/news/genetic-analysis-links-aspirin-use-to-increased-risk-of-early-and-dry-amd Fri, 12 Jun 2026 15:50:00 GMT https://eyewire.news/news/genetic-analysis-links-aspirin-use-to-increased-risk-of-early-and-dry-amd Key Takeaways

  • A Mendelian randomization analysis found that genetically predicted aspirin use was associated with an increased risk of early and dry AMD
  • The association appeared to be mediated by changes in lipid biomarkers—specifically lower LDL cholesterol and higher apolipoprotein A1 levels—rather than a direct effect of aspirin itself
  • Researchers said the findings should not prompt patients to stop prescribed aspirin therapy but may provide new insights into the role of lipid metabolism in AMD development and progression

A new genetic epidemiology study led by researchers in China has found evidence that aspirin use may increase the risk of developing early and dry age-related macular degeneration (AMD), with the association appearing to be mediated through changes in lipid metabolism rather than a direct effect of the drug itself.1

The study, published in the journal Eye, used a bidirectional two-sample Mendelian randomization (MR) approach to investigate the long-debated relationship between aspirin use and AMD. While previous observational studies have produced conflicting results, the authors sought to determine whether a causal genetic association exists between aspirin use and AMD and to identify potential biological mediators.

Using genetic datasets related to aspirin use, AMD, and lipid biomarkers, the investigators found that genetically predicted aspirin use was associated with an increased risk of both early-stage AMD and dry AMD. Notably, they did not identify evidence supporting a direct causal pathway from aspirin use to disease. Instead, the relationship appeared to be fully mediated by reductions in low-density lipoprotein cholesterol (LDL-C) and increases in apolipoprotein A1 (APOA1) levels.

Multivariable MR analyses showed that once LDL-C and APOA1 were accounted for, the apparent effect of aspirin on AMD was no longer statistically significant, suggesting these lipid-related factors may be driving the association.

The findings add a new dimension to an ongoing debate in ophthalmology. Earlier epidemiologic studies have reported mixed results, with some suggesting an increased risk of AMD among long-term aspirin users and others finding no significant association. Randomized clinical trials, including analyses from the ASPREE and Women's Health Study cohorts, have likewise produced inconsistent conclusions.

The study highlights the growing role of genetic causal-inference methods in understanding AMD risk factors. However, the authors caution that the results should not be interpreted as evidence to discontinue aspirin therapy prescribed for cardiovascular indications. 

The research also reinforces emerging evidence that lipid metabolism plays a central role in AMD pathogenesis. Previous genetic studies have implicated several lipid biomarkers in AMD risk, and the new analysis suggests that aspirin-related changes in lipid profiles may intersect with these pathways.

According to the investigators, the study provides "robust genetic evidence" linking aspirin use with increased risk of early and dry AMD through lipid-mediated mechanisms. They suggest future research should further explore the biological interplay between lipid regulation and retinal degeneration, as well as the potential implications for AMD prevention and risk stratification.

Reference

1. Zhu J, Zeng C, Tang R, et al. Causal relationship between aspirin use and age-related macular degeneration. Eye. Published May 29, 2026.

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Global Eye Care Leaders Gather to Mark Centre for Sight's 30 Years of Vision Care https://eyewire.news/news/global-eye-care-leaders-gather-to-mark-centre-for-sights-30-years-of-vision-care Fri, 12 Jun 2026 13:15:23 GMT https://eyewire.news/news/global-eye-care-leaders-gather-to-mark-centre-for-sights-30-years-of-vision-care Centre for Sight marked its 30th anniversary by convening some of the world's leading ophthalmologists, surgeons, innovators and entrepreneurs for a specialist conference examining the future of vision care.

The one-day event, titled "30 Years of Vision: Crafting the Next Decade," was held at Alexander House Hotel in West Sussex, UK, and brought together international experts to reflect on three decades of advances in ophthalmology while exploring emerging technologies expected to shape the next era of patient care.

Founded in 1996 by consultant ophthalmic surgeon Sheraz M. Daya, Centre for Sight has established itself as one of the UK's leading providers of refractive, cataract and complex eye care. The anniversary conference highlighted the role of technological innovation in transforming ophthalmology, with discussions centered on artificial intelligence, advanced diagnostics, laser technologies and evolving care delivery models.

"Over the past 30 years ophthalmology has seen remarkable transformation driven by technology, research and the dedication of clinicians committed to improving vision and quality of life," said Dr. Daya, medical director and founder of Centre for Sight. "This conference is an opportunity to reflect on that journey, share insights with colleagues and look ahead to the innovations that will define the next decade of patient care."

Among the conference's featured sessions was "Technologies That Influence Change," an extended panel discussion featuring internationally recognized key opinion leaders Arthur Cummings, Erik Mertens, Andrew Webb and Aylin Kiliç. The panel examined advances that have reshaped refractive and cataract surgery over the past three decades, including developments in diagnostics, femtosecond laser platforms and surgical planning technologies. Speakers also discussed the expanding role of artificial intelligence and advanced imaging tools in supporting clinical decision-making and improving surgical outcomes.

The program also included "Ophthalpreneurs Session – What's Missing?," led by Amanda Carones and Francesco Carones. The discussion explored unmet needs across patient experience, technology development and practice management, while examining how ophthalmologists can play a greater role in driving innovation within and beyond clinical practice.

A forward-looking session, "Influences Over the Next 10 Years," featured international experts including Milind Pande, Michael Mrochen, Pei-Fen Lin and Andrea Russo. Panelists discussed the growing influence of AI, private equity investment in healthcare, changing patient expectations and the impact of increasing life expectancy on future demand for vision correction and cataract procedures.

The anniversary celebrations concluded with a black-tie gala dinner featuring remarks from television presenter, author and campaigner Katie Piper. Ms. Piper, founder of the Katie Piper Foundation, has previously received treatment at Centre for Sight following injuries sustained in an acid attack.

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Epion Completes Final Patient Follow-Up in Phase 3 EpiSmart Keratoconus Trials https://eyewire.news/news/epion-completes-final-patient-follow-up-in-phase-3-epismart-keratoconus-trials Fri, 12 Jun 2026 12:49:17 GMT https://eyewire.news/news/epion-completes-final-patient-follow-up-in-phase-3-epismart-keratoconus-trials Key Takeaways

  • Epion Therapeutics has completed all patient follow-up visits in its two pivotal phase 3 trials evaluating EpiSmart, an investigational epithelium-on corneal cross-linking procedure for keratoconus
  • The double-masked, sham-controlled studies enrolled approximately 800 patients across 26 U.S. sites, with BSCDVA at 12 months serving as the primary endpoint
  • Following data analysis, Epion plans to pursue FDA approval of EpiSmart

Epion Therapeutics announced that the final patient has completed the last study visit in the company's phase 3 clinical program evaluating EpiSmart, an epithelium-on corneal cross-linking procedure. The completion of all follow-up examinations across both pivotal trials concludes patient participation in the program and positions the company to advance toward a planned regulatory submission to the FDA.

The phase 3 program consists of two identical, double-masked, sham-controlled studies designed to evaluate the safety and efficacy of EpiSmart in patients with keratoconus. Initiated in October 2023, the trials enrolled approximately 800 patients at 26 clinical sites across the United States. Participants represented a broad spectrum of disease severity, ranging from early tomographic diagnosis to advanced progressive keratoconus.

Patients were randomized in a 1:1 ratio to receive either EpiSmart or a sham procedure. When clinically appropriate, simultaneous bilateral treatment was performed. Both studies were designed with Best Spectacle-Corrected Distance Visual Acuity (BSCDVA) at 12 months as the primary efficacy endpoint, emphasizing functional vision outcomes.

“We believe EpiSmart represents the next step in the evolution of cross-linking,” said Michael D. Webb, President and CEO of Epion Therapeutics. “The completion of our phase 3 program brings us one step closer to making EpiSmart available to keratoconus patients and all who care for them.”

Pending positive study outcomes and regulatory review, Epion plans to submit a new drug application (NDA) to the FDA seeking approval of EpiSmart in the US.

In October 2025, the FDA granted Fast Track designation to EpiSmart for the treatment of keratoconus. The designation is intended to facilitate development and expedite review of therapies that address serious conditions and unmet medical needs.

EpiSmart is designed as a minimally invasive corneal cross-linking system intended to strengthen the cornea while preserving the epithelial surface. The platform combines a proprietary ocular-surface cleansing wand that avoids epithelial disruption, a loading sponge designed to promote uniform stromal drug distribution, and a fixed-dose riboflavin and iodide formulation intended to enhance cross-linking efficiency without supplemental oxygen.

The system also incorporates what Epion describes as the first bilateral UV-A treatment device for corneal cross-linking. The device uses a proprietary light-cycling protocol designed to support oxygen re-diffusion during treatment, a factor believed to play a critical role in the cross-linking process.

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Johnson & Johnson Expands US Rollout of Tecnis PureSee EDOF IOL https://eyewire.news/news/johnson-johnson-expands-us-rollout-of-tecnis-puresee-edof-iol Thu, 11 Jun 2026 14:20:40 GMT https://eyewire.news/news/johnson-johnson-expands-us-rollout-of-tecnis-puresee-edof-iol Key Takeaways

  • Johnson & Johnson Vision has expanded US availability of the Tecnis PureSee IOL, an extended depth of focus lens designed to provide a broader range of vision while maintaining visual quality for cataract patients
  • Tecnis PureSee is the first and only FDA-approved EDOF IOL in the United States without a warning for loss of contrast sensitivity
  • J&J has launched a patient lifestyle quiz aimed at helping individuals discuss visual goals and IOL options with their eye care providers ahead of cataract surgery

Johnson & Johnson has announced the expanded US availability of the Tecnis PureSee IOL, an extended depth of focus (EDOF) presbyopia-correcting lens designed to provide an extended range of vision while maintaining visual quality.

According to J&J, Tecnis PureSee is the first and only FDA-approved EDOF IOL in the United States that does not carry a warning regarding loss of contrast sensitivity, a key component of functional vision, particularly under mesopic conditions and in environments with reduced visibility. The company reports that the lens maintains contrast sensitivity comparable to an aspheric monofocal IOL while delivering an extended range of vision. The lens is intended to address both cataract-related vision loss and presbyopia during a single surgical procedure. 

“With the full US availability of Tecnis PureSee IOL, we are expanding access to an important extended depth of focus option that reflects our commitment to innovation, visual quality, and patient satisfaction,” said Erin Powers, president of Surgical Vision, North America, Johnson & Johnson. “Patients today want vision solutions that support how they live their lives every day. Tecnis PureSee IOL builds on the trusted Tecnis platform to help meet those expectations while giving surgeons greater flexibility to personalize care.”

In conjunction with the rollout, Johnson & Johnson Vision has launched a patient lifestyle assessment tool designed to facilitate preoperative discussions around visual goals and IOL selection. The online questionnaire encourages patients to evaluate daily visual demands and discuss available Tecnis lens options with their eye care provider.

Additional information for patients and providers is available through Johnson & Johnson Vision’s educational here and here

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Hexiris Ophthalmics Advances Toward 2026 Commercial Launch; Announces Presentations and Initiatives https://eyewire.news/news/hexiris-ophthalmics-advances-toward-2026-commercial-launch-announces-presentations-and-initiatives Thu, 11 Jun 2026 13:35:18 GMT https://eyewire.news/news/hexiris-ophthalmics-advances-toward-2026-commercial-launch-announces-presentations-and-initiatives Hexiris Ophthalmics, a Canadian ophthalmic device company developing technologies to expand access to interventional glaucoma care, announced a series of milestones that mark progress toward the commercial launch of its first products later in 2026.

The company’s presented scientific presentations at two international ophthalmology congresses, launched its corporate website and social media channels, continued momentum in its surgeon engagement program, and announced upcoming participation at the Canadian Ophthalmological Society (COS) annual meeting in Montreal, where surgeons will be invited to experience the company’s OBi platform through a hands-on dry lab.

At the American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting, Paul Harasymowycz, MD, FRCSC, presented data on office-based slit-lamp interventional glaucoma surgery. At the Mexican Society of Ophthalmology Meeting, José Ramón Ponce Martínez, MD, presented clinical experience with the same approach in a presentation titled: “Cirugía del Glaucoma Intervencional con Lámpara de Hendidura en el Consultorio.”

“Expanding access to interventional glaucoma is why Hexiris Ophthalmics exists,” said Dr. Houfar Sekhavat, Co-Founder of Hexiris Ophthalmics. “Too many patients who need treatment cannot get it, not because the surgery is unavailable, but because the settings in which it can be performed are out of reach. We are building the tools to change that, and we are genuinely excited to be moving closer to putting them in surgeons’ hands.”

Hexiris Ophthalmics will exhibit at the Canadian Ophthalmological Society (COS) annual meeting in Montreal this June. During the meeting, attending surgeons will have the opportunity to gain first-hand experience with OBi Core and OBi Gon through dedicated hands-on, in-booth dry lab sessions.

The sessions will provide participants with an opportunity to evaluate the company’s approach to office-based interventional glaucoma procedures and interact directly with the technology ahead of commercial launch. Space for the dry lab experience is limited, and pre-registration is encouraged. The devices featured are Health Canada approved and FDA registered.

The company has also introduced "Expanding Access," a quarterly newsletter designed to keep surgeons, industry partners, and investors informed about advances in interventional glaucoma care, clinical developments, and company milestones.

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Harrow Re-Launches Verkazia for Treatment of Vernal Keratoconjunctivitis https://eyewire.news/news/harrow-re-launches-verkazia-for-treatment-of-vernal-keratoconjunctivitis Thu, 11 Jun 2026 12:54:03 GMT https://eyewire.news/news/harrow-re-launches-verkazia-for-treatment-of-vernal-keratoconjunctivitis Key Takeaways

  • Harrow has re-launched Verkazia, a cyclosporine ophthalmic emulsion indicated for the treatment of vernal keratoconjunctivitis (VKC)
  • Physicians highlighted the need for steroid-sparing therapies that target the underlying inflammatory mechanisms of VKC, particularly in pediatric patients
  • The company is supporting the re-launch with physician education, patient access, and affordability initiatives 

Harrow announced the re-launch of Verkazia (cyclosporine ophthalmic emulsion) 0.1%, a prescription treatment indicated for vernal keratoconjunctivitis (VKC). 

“The re-launch of Verkazia underscores our commitment to advancing care in underserved ophthalmic conditions,” said Mark L. Baum, CEO of Harrow. “VKC is a clinically significant, yet highly underdiagnosed disease, affecting a vulnerable patient population, where the central challenge has not been clinical efficacy, but consistent access to therapy. Our focus with this re-launch is straightforward: ensure dependable supply, remove access barriers, and enable physicians and patients to reliably obtain this important, evidence-based, and, most importantly, steroid-sparing treatment for long-term disease management.”

VKC is a chronic, potentially sight-threatening condition characterized by significant ocular inflammation. Patients often experience severe itching, pain, photophobia and tearing, and in some cases may develop corneal damage. The disease typically begins in childhood and can persist through adolescence, with seasonal flare-ups and occasional continuation into adulthood.

Verkazia is a topical calcineurin inhibitor immunomodulator that targets the inflammatory pathways underlying VKC. According to Harrow, guidelines increasingly support earlier use of calcineurin inhibitors to reduce inflammation, minimize corticosteroid dependence and improve long-term outcomes.

“There remains a substantial need for effective, long-term VKC treatment options, particularly those that reduce steroid exposure,” said Elsa Sheerer, OD, pediatric optometrist at NYC Health + Hospitals. “The availability of a targeted cyclosporine formulation is an important advancement for clinicians managing this complex disease.”

Harrow noted that growing awareness of VKC and increasing emphasis on early disease-modifying treatment have created a significant opportunity to improve diagnosis and long-term management of the condition. The company said its commercial strategy for Verkazia includes physician education programs, patient access support and affordability initiatives designed to improve treatment adoption and continuity of care.

Santen received FDA approval Verkazia for VKC in children and adults in 2021. Harrow acquired the US and Canadian commercial rights to the drug in 2023.

Clinicians interested in prescribing Verkazia can obtain additional information through Harrow's customer support resources and product website.

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Zeiss Reports Successful Early Clinical Implantations of AT LUCIA Toric 721P IOL in Europe https://eyewire.news/news/zeiss-reports-successful-early-clinical-implantations-of-at-lucia-toric-721p-iol-in-europe Thu, 11 Jun 2026 12:36:03 GMT https://eyewire.news/news/zeiss-reports-successful-early-clinical-implantations-of-at-lucia-toric-721p-iol-in-europe Key Takeaways

  • Zeiss announced successful early clinical implantations of the AT LUCIA toric 721P, a new toric IOL designed to treat cataracts while correcting astigmatism
  • Early-access clinical trial surgeons across six European countries reported positive initial experiences
  • The CE-marked lens is expected to launch in select European markets later in 2026

Zeiss announced the successful early clinical implantations of the Zeiss AT LUCIA toric 721P IOL, a new toric lens designed to treat cataracts while simultaneously correcting astigmatism. The company is currently conducting an early-access clinical trial involving a select group of cataract surgeons across the Czech Republic, Germany, Italy, Spain, Sweden and the United Kingdom.

According to Zeiss, surgeons participating in the trial have reported positive early impressions of the lens, citing its precision, rotational stability and surgical handling characteristics. 

"The overwhelmingly positive feedback we've received from surgeons strongly validates our optics leadership in the IOL market," said Frank Seitzinger, Head of Business Sector Surgery Anterior Segment at Zeiss Medical Technology. "The Zeiss AT LUCIA toric 721P raises the bar for precision, stability, and ultimately positive surgical outcomes. This is a new era for IOL technology and Zeiss is at the forefront."

The company plans to showcase the AT LUCIA toric 721P for the first time at the International Congress of German Ophthalmic Surgery (DOC) in Nuremberg, Germany, taking place June 18-20, 2026. The lens has received CE marking and is expected to launch commercially in select European countries later this year.

Among the first surgeons to implant the lens was Andrea Janeková, PhD, FEBO, FEBOS-CR, Head of the Center for Cataract, Refractive and Vitreoretinal Surgery at Eye Center Prague in the Czech Republic.

"Being the first surgeon worldwide to implant the Zeiss AT LUCIA toric 721P was a privilege," Dr. Janeková said. "The lens combines precision, stability and excellent surgical handling. And in modern cataract surgery, precision matters more than ever. Based on my first experience, the Zeiss AT LUCIA toric 721P has all the ingredients of a true game changer for refractive outcomes."

Additional information on the clinical trial program and surgeon experiences is available from Zeiss.

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Ethyreal Bio Launches With $101 Million to Advance Potential Disease-Modifying Therapy for TED https://eyewire.news/news/ethyreal-bio-launches-with-101-million-to-advance-potential-disease-modifying-therapy-for-ted Wed, 10 Jun 2026 16:08:52 GMT https://eyewire.news/news/ethyreal-bio-launches-with-101-million-to-advance-potential-disease-modifying-therapy-for-ted Ethyreal Bio has launched with $101 million in financing to advance its lead program, ETHY-001, a monoclonal antibody designed to address the underlying driver of both Graves’ disease (GD) and thyroid eye disease (TED).

ETHY-001 represents a potentially novel approach targeting thyroid stimulating hormone receptor (TSHR) activation, a central pathogenic mechanism shared by both TED and GD. Unlike current therapies that typically address either the ocular manifestations of TED or the thyroid dysfunction associated with GD, ETHY-001 is designed to block autoantibody-mediated activation of TSHR, potentially addressing both conditions through a single mechanism-driven therapy.

According to the company, ETHY-001 is engineered to comprehensively inhibit disease activity while supporting a safety profile suitable for long-term administration. The antibody incorporates half-life extension technology intended to enable infrequent dosing and is formulated for low-volume subcutaneous delivery, with plans to develop an autoinjector.

“GD and TED are prevalent and debilitating conditions with a shared causal driver—pathogenic stimulating autoantibodies to the TSHR,” said Niranjan Kameswaran, PhD, CEO of Ethyreal Bio. “These two conditions frequently co-exist in the same individual, yet current treatments for GD do not treat or prevent TED, and conversely, TED treatments do not address the hyperthyroidism characteristic of GD. By blocking autoantibody activation of the TSHR, ETHY-001 is designed to target the underlying cause of disease and has the potential to address both conditions through a single, mechanism-driven therapy.”

Dr. Kameswaran said the company expects to initiate first-in-human clinical trials of ETHY-001 during the second half of 2026. Preclinical data will be presented at the Endocrine Society’s Annual Meeting (ENDO 2026) in Chicago on June 15.

The company’s leadership team includes Dr. Kameswaran as chief executive officer; Jessica Stromme as chief development officer; Kelly Foster, PhD, as senior vice president of translational medicine; and Stephen Huang, MD, as senior vice president of clinical development.

The Series A financing was co-led by Atlas Venture and Medicxi Ventures, with participation from Nandi Life Sciences and Checkpoint Capital. The subsequent Series B round included all Series A investors and was led by Avoro Capital.

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AAO Partners with OpenEvidence to Bring Specialty Guidelines Directly Into AI Clinical Workflow https://eyewire.news/news/aao-partners-with-openevidence-to-bring-specialty-guidelines-directly-into-ai-clinical-workflow Wed, 10 Jun 2026 13:24:12 GMT https://eyewire.news/news/aao-partners-with-openevidence-to-bring-specialty-guidelines-directly-into-ai-clinical-workflow Key Takeaways

  • AAO will integrate its Preferred Practice Patterns and Ophthalmic Technology Assessments into OpenEvidence, giving ophthalmologists free access to specialty-specific guidance within a cited AI-powered clinical workflow
  • Beyond content integration, the partnership establishes a feedback loop that provides the Academy with aggregated insights into physicians’ information needs

The American Academy of Ophthalmology (AAO) and OpenEvidence, a medical AI platform for physicians, announced a strategic partnership that will integrate the Academy's Preferred Practice Patterns and Ophthalmic Technology Assessments directly into the OpenEvidence platform.

The collaboration will make the Academy's clinical guidance available alongside the broader peer-reviewed medical literature within OpenEvidence's searchable, cited workflow, providing ophthalmologists with access to specialty-specific evidence at the point of care at no additional cost.

The American Academy of Ophthalmology represents more than 32,000 medical doctors worldwide. Its Preferred Practice Patterns' clinical guidelines in ophthalmology are developed through extensive evidence review and continuously updated by subspecialty experts.

Under the agreement, OpenEvidence will incorporate the Academy's clinical guidance into its AI models, enabling physicians to access specialty recommendations within the same workflow they use to search and evaluate medical literature. In addition, OpenEvidence will provide the Academy with aggregated, high-level insights into topics most frequently explored by ophthalmologists, helping identify emerging areas of interest and potential gaps in existing guidance.

"We evaluated the landscape carefully and chose OpenEvidence because of the rigor of their approach. Their models are trained on peer-reviewed literature, every answer is cited and verifiable, and they have built the infrastructure to integrate specialty-specific guidance with the depth and nuance that our physicians need—at a level that sets the bar for all," said Stephen D. McLeod, MD, CEO of the American Academy of Ophthalmology.

"This partnership is about more than content integration. Together, we are building a feedback loop between how ophthalmologists practice and how the Academy responds to these needs, using real-world usage data to identify gaps and priorities we couldn't see before. The age of AI offers opportunities for the medical profession to focus on real needs in real time, and the Academy intends to lead the way—with OpenEvidence as our partner," Dr. McLeod said. 

For OpenEvidence, the partnership represents an expansion of its strategy to incorporate specialty society guidance directly into clinical decision-support workflows.

"Ophthalmology is a field where the depth of subspecialty knowledge is critical and the clinical guidelines reflect decades of rigorous evidence review," said Travis Zack, MD, PhD, chief medical officer of OpenEvidence. "We're excited to work with the Academy to trailblaze the next steps in expert-guided practice, partnering to leverage AI tools and what we are learning about the real-world clinical knowledge requirements in ophthalmology to support the Academy in its efforts."

The arrangement is structured as a licensing agreement for the Academy's content. The Academy will retain sole intellectual and financial responsibility for developing and maintaining its Preferred Practice Patterns and Ophthalmic Technology Assessments.

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Dompé Doses First US Patient in Phase 3 Trial of Cenegermin-bkbj for Persistent Corneal Epithelial Defect https://eyewire.news/news/dompe-doses-first-us-patient-in-phase-3-trial-of-cenegermin-bkbj-for-persistent-corneal-epithelial-defect Tue, 09 Jun 2026 16:41:03 GMT https://eyewire.news/news/dompe-doses-first-us-patient-in-phase-3-trial-of-cenegermin-bkbj-for-persistent-corneal-epithelial-defect Key Takeaways

  • Dompé has dosed the first US patient in the phase 3 Orunea trial evaluating cenegermin-bkbj for persistent corneal epithelial defect
  • The randomized, double-masked study will enroll approximately 150 patients and assess whether the recombinant human nerve growth factor therapy can achieve complete corneal epithelial healing compared with placebo

Dompé has announced that the first patient in the United States has been dosed in the phase 3 Orunea clinical trial evaluating cenegermin-bkbj ophthalmic solution for the treatment of persistent corneal epithelial defect (PCED).

The multicenter, randomized, double-masked study is designed to compare cenegermin-bkbj with placebo in achieving complete healing of persistent corneal epithelial defects. The trial marks the latest expansion of Dompé's research program focused on recombinant human nerve growth factor (rhNGF), building on the company's experience in neurotrophic keratitis.

The phase 3 Orunea study is expected to enroll approximately 150 adults aged 18 years and older with PCED. The primary endpoint will assess the proportion of patients achieving complete epithelial healing of the cornea. According to Dompé, the trial is designed to evaluate whether targeting the biological mechanisms involved in epithelial repair can improve outcomes in patients whose corneal healing processes have been compromised.

"Advancing cenegermin-bkbj into a phase 3 program for PCED reflects the strength of the underlying science and the consistency of the rhNGF mechanism across corneal pathologies characterized by impaired healing," said Marcello Allegretti, Chief Scientific Officer at Dompé. "This study is designed to rigorously evaluate whether targeting the biological drivers of epithelial repair can offer a clinically meaningful benefit for patients with limited therapeutic options."

PCED occurs when the corneal epithelium fails to heal following injury or disease, leaving a persistent defect that remains unhealed for more than 2 weeks despite standard treatment. The condition can cause significant ocular pain, blurred vision, and increased risk of infection. If untreated, PCED may progress to severe corneal complications, including permanent scarring and partial or complete vision loss.

Cenegermin-bkbj remains investigational for the treatment of PCED, and its safety and efficacy for this indication have not been established by regulatory authorities.

Additional information about the Orunea trial is available on ClinicalTrials.gov under identifier NCT07519902.

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First Patient Randomized in Oculis' PREDICT-1 Trial for Dry Eye Disease https://eyewire.news/news/first-patient-randomized-in-oculis-predict-1-trial-for-dry-eye-disease Tue, 09 Jun 2026 16:31:54 GMT https://eyewire.news/news/first-patient-randomized-in-oculis-predict-1-trial-for-dry-eye-disease Key Takeaways

  • Oculis has randomized the first patient in PREDICT-1, the first genotype-based registrational trial in dry eye disease
  • The trial is evaluating licaminlimab in patients with a specific TNFR1 genetic profile linked to enhanced treatment response
  • The precision medicine study builds on phase 2 data showing greater improvements in dry eye signs and symptoms among TNFR1 genotype-positive patients

Oculis announced the randomization of the first patient in its pivotal PREDICT-1 (Personalized dRy Eye Disease Investigational Clinical Trial) study evaluating licaminlimab in dry eye disease (DED).

The milestone marks the launch of what Oculis describes as the first genotype-based registrational trial in DED. PREDICT-1 is designed to assess the efficacy and safety of licaminlimab, a topical anti-TNFα biologic, in patients carrying a specific TNFR1 genotype associated with enhanced treatment response. The randomized, multicenter, double-masked, vehicle-controlled study plans to enroll approximately 160 patients, with roughly two-thirds selected for the targeted TNFR1 genetic profile.

The trial’s primary endpoint is the change from baseline to Day 29 in global ocular discomfort severity among patients with the specified genotype. The same measure will also be assessed in the overall study population as a key secondary endpoint.

"Randomization of the first patient in PREDICT-1 marks an important milestone for licaminlimab and for the advancement of a genotype-based, precision medicine approach in dry eye disease, a highly unsatisfied market," said Riad Sherif, MD, Chief Executive Officer of Oculis. "Supported by a well-validated anti-TNFα mechanism of action, this targeted trial is designed to maximize clinical efficiency by focusing on patients most likely to respond."

According to Oculis, to improve trial efficiency and patient selection, PREDICT-1 incorporates a genotype screening phase prior to enrollment. Potential participants are assessed for both TNFR1 genotype status and symptom severity, measured using a global ocular discomfort severity score of at least 60 before and after an artificial tear run-in period.

The study builds on phase 2 findings showing that licaminlimab generated stronger clinical responses in patients carrying a specific TNFR1 genotype, producing meaningful improvements in both DED signs and symptoms. Researchers believe genetic variation within the TNF/TNFR1 inflammatory pathway may explain differences in patient responses and could represent a critical driver of ocular surface inflammation in dry eye disease.

If confirmed in PREDICT-1, these findings could support the first precision medicine treatment paradigm in ophthalmology, Oculis stated. 

"We believe Licaminlimab, if approved, has the potential to reshape the treatment paradigm for this multifactorial disease," Dr. Sherif said. "By pioneering an innovative development strategy, our objective is to deliver a precision medicine approach that addresses a major unmet need for the millions of underserved patients currently constrained by a trial-and-error method."

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Optos Appoints Alexandre Montague as Chief Executive Officer https://eyewire.news/news/optos-appoints-alexandre-montague-as-chief-executive-officer Tue, 09 Jun 2026 13:10:32 GMT https://eyewire.news/news/optos-appoints-alexandre-montague-as-chief-executive-officer Optos has appointed Alexandre “Alex” Montague as chief executive officer, effective immediately.

Mr. Montague joins Optos with nearly 25 years of global leadership experience across healthcare, ophthalmology, vision care, and medical technology. He most recently served as CEO of Hoya Vision Care, where he led a global organization of approximately 20,000 employees operating across 35 subsidiaries worldwide. Prior to Hoya, Mr. Montague held senior leadership positions at Essilor and Zeiss. Throughout his career, he has been recognized for fostering innovation, developing high-performing teams, and driving growth through customer-focused strategies, according to Optos. 

“Optos has a powerful sense of purpose and an extraordinary opportunity to continue advancing eye care worldwide,” said Mr. Montague. “The company’s commitment to innovation, clinical excellence, and enabling health care professionals to improve patient outcomes strongly resonates with me. I look forward to building on the well-established Optos foundation, supporting our customers, empowering our talented teams, and expanding our impact.”

“If our focus is purposeful, making meaningful investments for patients, clinicians, and society, the results will follow. If we act early enough, we can change outcomes for entire generations," he said. 

Mr. Montague replaces Robert Kennedy, who is now Chief Financial Officer of Scotland-based iGii, a privider of 3D carbon nanomaterial. 

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Heidelberg Engineering Receives FDA Clearance for Enhanced Imaging Software on Spectralis https://eyewire.news/news/heidelberg-engineering-receives-fda-clearance-for-enhanced-imaging-software-on-spectralis Tue, 09 Jun 2026 12:51:35 GMT https://eyewire.news/news/heidelberg-engineering-receives-fda-clearance-for-enhanced-imaging-software-on-spectralis Key Takeaways

  • Heidelberg Engineering has received FDA clearance for the latest Spectralis Software Version, introducing faster OCTA imaging, expanded multimodal capabilities, and workflow enhancements 
  • The new 250 kHz OCTA scan speed, combined with enhanced TruTrack Active Eye Tracking and SHIFT Technology, delivers the fastest OCTA image acquisition available on Spectralis 

Heidelberg Engineering announced FDA clearance for the latest Spectralis software, which introduces new imaging capabilities designed to enhance workflow efficiency, diagnostic confidence, and patient-centered care.

According to Heidelberg, the software release delivers advances in multimodal retinal imaging, including a new 250 kHz scan speed for Optical Coherence Tomography Angiography (OCTA), enhanced TruTrack Active Eye Tracking, and the introduction of the Green Autofluorescence Module. The new features are designed to expand clinical insight while maintaining the image quality and data consistency of the Spectralis platform.

Faster OCTA Imaging with SHIFT Technology

The latest release of Spectralis with SHIFT Technology introduces a 250 kHz scan speed for OCTA imaging, complementing the platform’s existing 85 kHz and 125 kHz acquisition speeds. Supported by enhanced TruTrack Active Eye Tracking, the new scan speed delivers the fastest OCTA image acquisition available on Spectralis to date, helping accelerate imaging workflows in clinical practice.

The platform’s multi-speed imaging approach allows clinicians to tailor acquisition settings based on individual patient needs and clinical objectives, balancing image detail and acquisition time while supporting efficient patient throughput.

The newly introduced Green Autofluorescence Module enhances visualization of the macula and supports the identification of clinically relevant features, including foveal sparing in patients with macular atrophy. The technology is designed to aid diagnosis, patient selection, and disease monitoring, while compatibility with Heidelberg Engineering’s RegionFinder software enables quantification of atrophy for clinical assessment and longitudinal analysis. Combined with BluePeak blue autofluorescence imaging, the Green Autofluorescence Module provides clinicians with complementary views of retinal structure and metabolic changes, offering a more comprehensive understanding of disease progression.

The software release also includes additional features intended to improve clinical workflow efficiency, patient comfort, and advanced imaging capabilities across the Spectralis platform, according to Heidelberg.

Commercial availability of the FDA-cleared software is planned for the second half of the year.

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Alkeus Doses First Patient in Global Phase 3 NORTHSTAR Trial of Gildeuretinol for Stargardt Disease https://eyewire.news/news/alkeus-doses-first-patient-in-global-phase-3-northstar-trial-of-gildeuretinol-for-stargardt-disease Mon, 08 Jun 2026 17:49:05 GMT https://eyewire.news/news/alkeus-doses-first-patient-in-global-phase-3-northstar-trial-of-gildeuretinol-for-stargardt-disease Key Takeaways

  • Alkeus Pharmaceuticals has dosed the first patient in its global phase 3 NORTHSTAR trial evaluating oral gildeuretinol (ALK-001) for Stargardt disease
  • The 24-month, placebo-controlled study will assess whether gildeuretinol can slow the growth of atrophic retinal lesions and preserve visual acuity
  • The FDA- and EMA-aligned trial is expected to enroll patients at approximately 55 sites across more than 11 countries

Alkeus Pharmaceuticals has dosed the first patient in its global phase 3 NORTHSTAR study evaluating oral gildeuretinol (ALK-001) for Stargardt disease. The first participant was enrolled and dosed at Erie Retina Research in Pennsylvania.

The NORTHSTAR trial is designed to assess the efficacy, safety and pharmacokinetics of gildeuretinol in patients with advanced Stargardt disease.

“We are tremendously excited to begin dosing in our pivotal global phase 3 NORTHSTAR study evaluating oral gildeuretinol in Stargardt disease, which represents an important step forward in the development of a much-needed treatment for patients impacted by this severely debilitating disease,” said Michel Dahan, President and CEO of Alkeus Pharmaceuticals. “We are particularly excited about the potential of gildeuretinol to preserve visual acuity as observed in our studies to date.”

The randomized, placebo-controlled, double-masked 24-month study (NCT07419334) will evaluate patients with advanced Stargardt disease who have atrophic retinal lesions at baseline. The trial’s primary endpoint is the rate of growth of atrophic lesions between months 6 and 24, while the key secondary endpoint is preservation of visual acuity as measured by low luminance visual acuity (LLVA).

According to the company, the phase 3 study design was developed in consultation with both the FDA and the European Medicines Agency (EMA). Approximately 55 sites across more than 11 countries are expected to participate in the global trial.

“There remains a significant unmet need in Stargardt disease, and continued progress in research is important for patients and families affected by this condition,” said David R.P. Almeida, MD, principal investigator at Erie Retina Research. “This study demonstrates a shared commitment to better understand the disease and to evaluate gildeuretinol’s potential as a treatment for Stargardt disease.”

The NORTHSTAR study will use fundus autofluorescence (FAF) imaging to measure the progression of atrophic lesions, which reflect retinal cell loss. Investigators will also assess LLVA, a measure of visual function under low-light conditions that may be more sensitive than traditional best-corrected visual acuity testing in detecting early declines in vision.

Alkeus reported that approximately 400 patients have received gildeuretinol across clinical studies to date. The company said the investigational therapy has demonstrated a favorable tolerability profile, including treatment durations exceeding 7 years and use in patients as young as 8 years old. No cases of chromatopsia, delayed dark adaptation or night blindness have been reported, findings that Alkeus attributes to the drug’s mechanism of action, which does not disrupt the visual cycle.

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FDA Issues Draft Guidance to Accelerate Development of Gene Therapies Using Existing Scientific Knowledge https://eyewire.news/news/fda-issues-draft-guidance-to-accelerate-development-of-gene-therapies-using-existing-scientific-knowledge Mon, 08 Jun 2026 14:11:14 GMT https://eyewire.news/news/fda-issues-draft-guidance-to-accelerate-development-of-gene-therapies-using-existing-scientific-knowledge The FDA released draft guidance aimed at helping developers bring promising gene therapies to patients more efficiently by leveraging existing scientific and regulatory knowledge throughout the development process.

The draft guidance, once finalized, will provide recommendations for sponsors developing human gene therapy products that use genome editing in human somatic cells. It outlines how companies can use publicly available information and established platform knowledge—including chemistry, manufacturing and controls (CMC) data, nonclinical study results, and clinical evidence—to streamline regulatory submissions and reduce development burdens.

The new guidance could have a meaningful effect on the clinical development of potential treatments for inherited retinal diseases (IRDs). 

"For years, one of the biggest barriers to getting gene therapies approved has been the regulatory pathway. Proving efficacy in rare diseases is difficult when patient populations are small and traditional trial designs simply don't fit," said Jason Menzo, CEO of the Foundation Fighting Blindness. "The FDA's new draft guidance is a meaningful step toward addressing that. By allowing developers to build on existing clinical, manufacturing, and nonclinical knowledge, the agency is signaling that our field has accumulated enough shared scientific foundation to support a more efficient path forward."

"For the IRD community specifically, this shifts the landscape significantly. Decades of patient data, natural history studies, and disease-specific research don’t happen overnight—and they are exactly what the industry needs right now," he added.

The guidance is intended to support a broad range of cell and gene therapy products, including those that utilize genome editing technologies. It forms part of a broader package of FDA initiatives designed to advance the development of innovative therapies.

“Today’s action reflects the FDA's commitment to get safe and effective cell and gene therapies to patients faster, particularly those living with rare and life-threatening diseases who have few or no other treatment options,” said Karim Mikhail, B. Pharm., M.S., Acting Director of the FDA’s Center for Biologics Evaluation and Research (CBER). “By providing information on how companies may build on what is already known, we are accelerating innovation without compromising the rigorous scientific standards that patients and the public depend on. Ultimately, this is about making sure that the promise of gene therapy reaches the patients who need it most, as quickly and safely as possible.”

According to the agency, the new guidance complements the FDA’s Plausible Mechanism Framework by providing practical approaches for using shared scientific knowledge and data to establish evidence supporting genome editing therapies. It also aligns with the agency’s recently issued draft guidance, "Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing," which outlines recommendations for assessing potential off-target editing risks.

Together, these efforts are intended to provide developers with a clearer, science-based pathway for incorporating prior knowledge into product development while maintaining safeguards to protect patients.

“By outlining how sponsors can intelligently build upon existing nonclinical, clinical, and manufacturing knowledge, we can meaningfully streamline development programs and lower the cost barriers that have historically slowed access to these potentially life-changing treatments,” said Vijay Kumar, MD, Acting Director of the Office of Therapeutic Products in CBER.

“Leveraging prior knowledge does not mean lowering the bar; it means raising our collective efficiency while maintaining the highest standards of safety and efficacy,” Dr. Kumar added. “For patients living with serious or rare diseases, time matters. We encourage developers to engage with this guidance because their perspectives are essential to shaping a regulatory framework that works for everyone, and most importantly, for the patients who are counting on us.”

The FDA noted that sponsors seeking to rely on existing data must provide a scientific rationale demonstrating how the information applies to their specific product and development program. The agency also encourages companies to engage early with regulators, including through Initial Targeted Engagement for Regulatory Advice on CBER/CDER Products (INTERACT) meetings and pre-Investigational New Drug (pre-IND) consultations.

The draft guidance is now available for public comment. Interested stakeholders have 90 days following publication in the Federal Register to submit feedback through Regulations.gov. The FDA said it will review and consider all comments received before issuing a final version of the guidance.

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Sleep Apnea Associated With Higher Incidence of Glaucoma in Real-World Analysis https://eyewire.news/news/sleep-apnea-associated-with-higher-incidence-of-glaucoma-in-real-world-analysis Mon, 08 Jun 2026 12:56:16 GMT https://eyewire.news/news/sleep-apnea-associated-with-higher-incidence-of-glaucoma-in-real-world-analysis Key Takeaways

  • In a study of more than 12.5 million adults, obstructive sleep apnea (OSA) was associated with a significantly higher risk of developing glaucoma compared with sleep-tested patients without OSA
  • Patients with OSA who had a record of positive airway pressure (PAP) therapy showed the highest glaucoma incidence
  • The findings do not prove that PAP therapy causes glaucoma, but they suggest that patients undergoing evaluation or treatment for OSA may benefit from regular ophthalmic monitoring

Researchers found that people diagnosed with obstructive sleep apnea (OSA) were more likely to develop glaucoma than patients who underwent sleep testing but were not diagnosed with the condition. The highest rates were observed among patients with records indicating use of positive airway pressure (PAP) therapy, a common treatment for OSA.1

The findings, published in Ophthalmology Glaucoma, suggest that patients being evaluated or treated for sleep apnea may benefit from closer ophthalmic monitoring, although the researchers cautioned that the study does not establish whether PAP therapy itself influences glaucoma risk.

"Our findings indicate an association between OSA and future glaucoma development, but the observed differences among treatment groups should be interpreted cautiously," the study authors wrote.

The retrospective cohort study drew on data from Epic Cosmos, a multicenter electronic health record database. Investigators identified adults who underwent evaluation for OSA between Jan. 1, 2010, and Oct. 31, 2025. Patients with a prior glaucoma diagnosis were excluded.

The final study population included more than 12.5 million patients with a mean age of 60.4 years, of whom 43.7% were women. Participants were divided into three groups: sleep-tested controls without OSA, patients with OSA who did not have a PAP device record, and patients with OSA who had a PAP device record within 180 days of evaluation.

Patients were followed for an average of 5.2 years, during which researchers identified 153,083 new cases of glaucoma.

The study found a clear gradient in glaucoma incidence across the three groups.

Crude incidence rates per 1,000 person-years were:

  • 1.74 among sleep-tested controls
  • 2.38 among patients with OSA without a PAP device record
  • 3.39 among patients with OSA with a PAP device record

After adjusting for baseline characteristics, researchers found that patients with OSA remained at elevated risk of developing glaucoma.

Compared with controls, patients with OSA and no PAP device record had a 27% higher risk of incident glaucoma (hazard ratio [HR] 1.27; 95% confidence interval [CI], 1.22–1.32). Patients with OSA who had a PAP device record had more than double the risk of developing glaucoma (HR 2.10; 95% CI, 1.80–2.45). At 10 years, cumulative glaucoma incidence reached 1.58% in controls, 2.30% in the untreated OSA group, and 3.86% in the PAP-record group.

Although glaucoma risk was highest among patients with documented PAP use, the researchers stressed that the study was not designed to determine whether PAP treatment increases or decreases glaucoma risk. Patients receiving PAP therapy often have more severe sleep apnea, making it difficult to separate the effects of treatment from the effects of underlying disease severity. The authors noted that residual confounding related to treatment indication likely influenced the results.

Researchers say the study should not be interpreted as evidence that PAP therapy causes glaucoma, but rather the findings highlight a broader association between OSA and eye health, and underscore the need for further research to clarify how sleep apnea severity, treatment patterns and ocular outcomes interact. Future studies with more detailed measures of OSA severity, PAP adherence and ophthalmic outcomes may help determine whether specific treatment approaches modify glaucoma risk.

Reference

1. Nishida T, Mittal R, Weinreb RN, et al. Positive airway pressure and long-term glaucoma risk in obstructive sleep apnea: a real-world cohort study. Ophthalmol Glaucoma. Published online 2026. doi:10.1016/j.ogla.2026.04.001.

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Everest Medicines Acquires Greater China Rights to Lenz Therapeutics’ Presbyopia Eye Drop Vizz https://eyewire.news/news/everest-medicines-acquires-greater-china-rights-to-lenz-therapeutics-presbyopia-eye-drop-vizz Mon, 08 Jun 2026 12:40:02 GMT https://eyewire.news/news/everest-medicines-acquires-greater-china-rights-to-lenz-therapeutics-presbyopia-eye-drop-vizz Key Takeaways

  • Everest Medicines acquired Greater China rights to Lenz Therapeutics’ presbyopia treatment Vizz (LNZ100) from Corxel Pharmaceuticals
  • LNZ100 is currently under regulatory review in China following NDA submission in September 2025, with approval anticipated in the first quarter of 2027

Lenz Therapeutics and Everest Medicines have expanded their partnership around presbyopia treatment Vizz (aceclidine ophthalmic solution) 1.44%, with Everest acquiring Greater China rights to the product through an asset purchase agreement with Corxel Pharmaceuticals.

The transaction transfers to Everest the rights and obligations under Corxel’s April 2022 licensing agreement with Lenz for Vizz, known in China as LNZ100. The deal covers mainland China, Hong Kong, Macao, and Taiwan and positions Everest to lead development, regulatory activities, manufacturing, and commercialization efforts across the region.

The move comes as LNZ100 advances through the Chinese regulatory process. A new drug application (NDA) was submitted to the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) in September 2025, with approval anticipated in the first quarter of 2027.

For Lenz, the agreement preserves the economic terms of its existing partnership structure. The company remains eligible to receive up to $85 million in remaining regulatory and commercial milestones, along with tiered royalties ranging from the mid-single digits to low double digits on net sales in Greater China. Lenz is also entitled to additional payments associated with the execution of the transaction between Corxel and Everest.

“LNZ100 is a differentiated asset with meaningful clinical value and strong commercial potential in the treatment of presbyopia,” said Yifang Wu, chairman of Everest Medicines. “As the presbyopia patient population continues to grow, significant unmet needs remain in noninvasive treatment options.”

Vizz, which was approved by the FDA in July 2025, became the first FDA-approved aceclidine-based eye drop for presbyopia in the United States.

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Large International Study Finds No Link Between Semaglutide and Wet AMD Risk https://eyewire.news/news/large-international-study-finds-no-link-between-semaglutide-and-wet-amd Fri, 05 Jun 2026 15:59:02 GMT https://eyewire.news/news/large-international-study-finds-no-link-between-semaglutide-and-wet-amd Key Takeaways

  • A study of 227,971 adults with type 2 diabetes found no evidence that semaglutide increases or decreases the risk of wet AMD
  • Researchers compared semaglutide users with patients taking other GLP-1 receptor agonists and several non-GLP-1 diabetes medications, finding no statistically significant differences in AMD risk

A large international study has found no evidence that semaglutide, the blockbuster diabetes and weight-loss medication, increases the risk of developing wet age-related macular degeneration (AMD).1

The research, published in Ophthalmology, examined health records from more than 227,000 adults with type 2 diabetes who were prescribed semaglutide. Investigators found that patients taking the drug were no more likely to develop wet AMD than patients using several other commonly prescribed diabetes medications.

The findings address growing questions about the eye safety of semaglutide and other glucagon-like peptide-1 receptor agonists (GLP-1RAs), a class of drugs that has transformed the treatment of diabetes and obesity in recent years.

“Recent studies have reported conflicting results regarding the relationship between semaglutide and macular degeneration,” the researchers noted. Some earlier analyses suggested an elevated risk of wet AMD, while others reported a potential protective effect.

To clarify the issue, researchers from the Observational Health Data Sciences and Informatics (OHDSI) network conducted a large retrospective study using data from 12 healthcare databases spanning electronic health records and insurance claims. The study period covered December 2017 through December 2024. A total of 227,971 new users of semaglutide were included in the study.

The team compared semaglutide users with patients taking other GLP-1 medications, including dulaglutide and exenatide, as well as non-GLP-1 diabetes drugs such as empagliflozin, sitagliptin and glipizide. They also used a separate self-controlled analysis that compared patients’ risk during periods when they were taking the medication versus periods when they were not.

Across both approaches, the researchers found no statistically significant increase in the risk of wet AMD associated with semaglutide use.

The risk of NVAMD among semaglutide users was similar to users of dulaglutide (NVAMD-C HR 0.57, 95% CI 0.21 to 1.57, P=.28; NVAMD-CP HR 0.25, 95% CI 0.05 to 1.27, P=.10), empagliflozin (NVAMD-C HR 0.98, 95% CI 0.54 to 1.79, P=.94; NVAMD-CP HR 0.79, 95% CI 0.38 to 1.64, P=.52), sitagliptin (NVAMD-C HR 2.08, 95% CI 0.90 to 4.83, P=.09; NVAMD-CP HR 1.80, 95% CI 0.55 to 5.86, P=.33), and glipizide (NVAMD-C HR 0.83, 95% CI 0.35 to 2.02, P=0.69; NVAMD-CP HR 0.50, 95% CI 0.21 to 1.19, P=.12). There was no evidence of increased or decreased risk for NVAMD associated with semaglutide exposure (NVAMD-C: incidence rate ratio [IRR] 0.92, 95% CI 0.67 to 1.26, P=.60; NVAMD-CP IRR 1.02, 95% CI 0.76 to 1.36, P=.92) nor any of the other GLP-1RA or non-GLP-1RAs.

“Our findings suggest that semaglutide is not associated with a large increase or decrease in NVAMD risk among adults with type 2 diabetes,” the authors concluded.

The study also found no evidence that the comparison diabetes medications altered the risk of NVAMD.

The authors cautioned that their study cannot completely rule out small effects in either direction. Because the research relied on diagnostic and procedure codes in healthcare databases, some uncertainty remains regarding disease classification. In addition, the overall number of wet AMD cases was relatively small compared with the size of the study population. Still, researchers said the study’s scale, diverse patient populations and rigorous methodology strengthen confidence in the results. 

Reference

1. Cai CX, Toy B, Martin B, et al. Semaglutide and neovascular age-related macular degeneration among adults with type 2 diabetes: an OHDSI network study. Ophthalmology. Published online May 21, 2026. doi:10.1016/j.ophtha.2026.05.034.

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International Meta-Analysis Finds Higher-Dose Atropine Linked to Clinically Meaningful Accommodation Changes in Pediatric Myopia Control https://eyewire.news/news/international-meta-analysis-finds-higher-dose-atropine-linked-to-clinically-meaningful-accommodation-changes-in-pediatric-myopia-control Fri, 05 Jun 2026 13:52:04 GMT https://eyewire.news/news/international-meta-analysis-finds-higher-dose-atropine-linked-to-clinically-meaningful-accommodation-changes-in-pediatric-myopia-control Key Takeaways

  • A systematic review and meta-analysis of 13 randomized controlled trials found that atropine's effects on accommodation and binocular vision are dose-dependent
  • Atropine 0.01% was associated with minimal effects on accommodative amplitude and binocular visual function, supporting its favorable tolerability profile 
  • Concentrations of 0.05% and higher were linked to clinically meaningful reductions in accommodative amplitude

A new systematic review and meta-analysis published in Ophthalmic and Physiological Optics examines how atropine concentration affects accommodative and binocular visual function in children receiving treatment for myopia control. The analysis found that atropine's effects on accommodation are dose-dependent, with low-dose regimens demonstrating minimal functional impact while higher concentrations produce clinically meaningful reductions in accommodative amplitude.

The study, led by Clara Martínez-Pérez, OD, PhD, and colleagues, evaluated 13 randomized controlled trials comparing atropine concentrations ranging from 0.01% to 1.0% against placebo, single-vision correction, or no treatment. Researchers examined changes in accommodative amplitude, accommodative lag, stereoacuity, heterophoria, and fusional vergence in children and adolescents undergoing myopia treatment.

Among the key findings, atropine 0.01% was associated with a small but statistically significant reduction in accommodative amplitude. However, the magnitude of change was modest and did not consistently translate into clinically meaningful effects across follow-up periods. Investigators also found no significant impact on accommodative lag, stereoacuity, or most binocular vision parameters at this concentration.

The findings reinforce the growing perception among clinicians that ultra-low-dose atropine offers a favorable balance between myopia-control efficacy and visual tolerability, particularly for children with substantial near-work demands, researchers stated.

The analysis found greater variability with intermediate concentrations of 0.02% to 0.03%, while atropine 0.05% produced a more consistent reduction in accommodative amplitude and measurable changes in binocular visual function. Concentrations of 0.1% and higher were associated with pronounced cycloplegic effects and substantially greater accommodative impairment.

According to the authors, the findings suggest that clinicians should proactively assess accommodative and binocular vision status when prescribing higher-concentration atropine, particularly in children reporting near blur, asthenopia, or reading difficulties. In some cases, additional management strategies such as near additions or adjustments to treatment regimens may be appropriate.

The authors conclude that while low-dose atropine maintains a strong safety profile with minimal effects on accommodation, higher concentrations may require more comprehensive monitoring and patient counseling. The authors note that future research should further investigate the long-term clinical significance of atropine-induced accommodative changes and determine whether specific patient populations may be more susceptible to functional side effects. 

Reference

1. Martínez-Pérez C, Santodomingo-Rubido J, Villa-Collar C. Dose-Dependent Effects of Atropine on Accommodative and Binocular Visual Function for Myopia Control in Children: A Systematic Review and Meta-Analysis. Ophthalmic Physiol Opt. Published online May 18, 2026. doi:10.1007/s44402-026-00093-5.

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Cloudbreak Pharma Nears Key Data Readout in Phase 3 Pterygium Program https://eyewire.news/news/cloudbreak-pharma-nears-key-data-readout-in-phase-3-pterygium-program Fri, 05 Jun 2026 12:53:25 GMT https://eyewire.news/news/cloudbreak-pharma-nears-key-data-readout-in-phase-3-pterygium-program Key Takeaways

  • Cloudbreak Pharma reported that the final patient has completed the 12-month assessment in its global phase 3 trial of CBT-001 for pterygium
  • Topline 12-month data are expected in the third quarter of 2026 and could support regulatory submissions 
  • CBT-001 is a multi-kinase inhibitor designed to target the underlying fibrovascular mechanisms of disease by inhibiting PDGF, VEGF and FGF signaling pathways

Cloudbreak Pharma has reached a development milestone for CBT-001, its investigational therapy for pterygium, with the final patient completing the 12-month assessment in the company's global phase 3 clinical trial.

The milestone marks completion of the primary efficacy evaluation period and sets the stage for a topline data readout expected in the third quarter of 2026. The study is evaluating CBT-001's ability to reduce pterygium lesion size and improve patient-reported ocular symptoms.

Positive results could position CBT-001 as a potential first approved drug therapy for pterygium, a common ocular surface disease characterized by fibrovascular tissue growth onto the cornea. Currently, surgery remains the primary treatment option for patients with progressive disease, despite recurrence rates that can remain significant following excision.

"Pterygium remains an area of significant unmet need in ophthalmology," said Abu Abraham, MD, Chief Medical Officer at Cloudbreak Pharma. "Our approach targets multiple receptor tyrosine kinases implicated in the disease process, including PDGF, VEGF and FGF, with the goal of modifying the underlying fibrovascular pathology rather than simply managing symptoms."

CBT-001 is derived from Cloudbreak's proprietary Multi-Kinase Inhibitor (MKI) platform and is designed to simultaneously inhibit pathways involved in angiogenesis, fibrosis and inflammation—mechanisms believed to contribute to pterygium growth and progression.

The phase 3 study enrolled 660 patients across sites in the United States, China, New Zealand, Australia and India. The multicenter, double-masked, randomized, vehicle-controlled trial is evaluating two dose levels of CBT-001 emulsion administered twice daily over 24 months. Key efficacy assessments occur at Months 3 and 12, with endpoints focused on reducing conjunctival hyperemia associated with the vascularized lesion and preventing disease progression.

Enrollment began in the United States in June 2022 and expanded internationally over the following 2 years. The company completed patient enrollment in May 2025. Topline results from the 12-month analysis are expected in the third quarter of 2026.

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Tavo Biotherapeutics Announces $17 Million Financing to Advance Novel Therapies in Glaucoma and Retinal Disease https://eyewire.news/news/tavo-biotherapeutics-announces-17-million-series-a-financing-to-advance-novel-therapies-in-glaucoma-and-retinal-disease Thu, 04 Jun 2026 17:10:48 GMT https://eyewire.news/news/tavo-biotherapeutics-announces-17-million-series-a-financing-to-advance-novel-therapies-in-glaucoma-and-retinal-disease Key Takeaways

  • Tavo Biotherapeutics closed a $17 million Series A financing to advance its pipeline of innovative therapies targeting glaucoma and retinal disease

Tavo Biotherapeutics announced the successful closing of a $17 million Series A financing led by Pureos Bioventures with participation by Polaris Partners and continued support from existing investor Tau Capital. The proceeds will be used to advance Tavo's pipeline of innovative therapies targeting glaucoma and retinal disease.

In conjunction with the financing, Tavo Biotherapeutics also announced the appointment of Federico Grossi, MD, PhD, as Chief Medical Officer, to lead the company's clinical development strategy and execution. Previously, Dr. Grossi was Chief Medical Officer of Apellis Pharmaceuticals, where he led clinical development for two groundbreaking FDA-approved therapies: Syfovre for geographic atrophy and Empaveli for paroxysmal nocturnal hemoglobinuria (PNH).

In addition, Tavo announced that Daniel Bradbury has joined the Board of Directors as Chairman. Mr. Bradbury is a life sciences executive with over 40 years of experience creating and implementing strategies to bring novel medicines to market. Mr. Bradbury is the former Chief Executive Officer of Amylin Pharmaceuticals, a biopharmaceutical company that launched three first-in-class medicines focused on metabolic diseases before its acquisition by Bristol-Myers Squibb Company in 2012.

In conjunction with the financing, Dominik Escher, PhD, and Nil Gural, PhD, have joined Tavo's Board of Directors representing Pureos Bioventures and Polaris Partners, respectively, bringing deep expertise in company building, financing, and the development of innovative therapeutics.

"We are thrilled to partner with Pureos and Polaris, and we are grateful for the continued support of Tau Capital," said Gary Berman, Chief Executive Officer of Tavo Biotherapeutics. "This financing enables us to accelerate the advancement of our programs in glaucoma and retinal disease, where there remains a critical need for new, more effective treatment options. We are also excited to welcome Fede to the team. His deep clinical and development experience will be invaluable as we advance our pipeline."

"Tavo has built a compelling pipeline addressing major unmet needs in ophthalmology with differentiated science and a clear clinical development strategy," said Dominik Escher. "We believe these programs have the potential to bring much better treatment options to patients. We are excited to lead this financing and support Tavo through its next phase of growth."

The new capital will support ongoing clinical and preclinical development activities for TAV-001 and TAV-002, as well as expand Tavo's research capabilities as the company progresses toward key clinical milestones.

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NEI-Supported Researchers Launch Open-Access Tool to Expand Access to Amblyopia Care for Children https://eyewire.news/news/nei-supported-researchers-launch-open-access-tool-to-expand-access-to-amblyopia-care-for-children Thu, 04 Jun 2026 13:23:15 GMT https://eyewire.news/news/nei-supported-researchers-launch-open-access-tool-to-expand-access-to-amblyopia-care-for-children Key Takeaways

  • Researchers supported by the National Eye Institute (NEI) have launched ANDI, a free online decision-support tool that helps eye care providers diagnose and manage amblyopia
  • The tool was developed to expand access to evidence-based pediatric eye care in regions facing shortages of pediatric ophthalmologists and optometrists
  • ANDI guides providers through the full course of amblyopia care—from selecting the appropriate glasses prescription and monitoring progress to recommending patching, atropine drops, digital therapies, follow-up care, and referral decisions when needed

A team of pediatric eye disease researchers supported by the National Eye Institute (NEI) has launched a new open-access clinical decision-support tool designed to help eye care providers diagnose and manage amblyopia in children.

Known as the "Amblyopia Navigator Decision-Support Instrument (ANDI)," the web-based platform aims to expand access to evidence-based pediatric eye care expertise at a time when many regions of the United States face shortages of pediatric ophthalmologists and pediatric optometrists.

“This online tool quickly distills the relevant literature into individualized treatment advice for busy clinicians anywhere with internet access,” Allison Summers, OD, associate professor at Oregon Health & Science University in Portland and lead author of the study describing the tool, said in an NEI news release. “Those without internet access can utilize the article figures as clinical reference sheets.”

According to the NEI, amblyopia is the leading cause of preventable vision loss in one eye among children, affecting approximately three out of every 100 children nationwide. During early childhood, the brain learns to combine images from both eyes into a single visual experience. Amblyopia can occur when this process is disrupted by conditions such as eye misalignment (strabismus), significant differences in prescription strength between the eyes, uncorrected refractive errors in both eyes, or visual obstruction caused by cataracts or drooping eyelids.

The need for broader access to treatment guidance has become increasingly apparent as workforce studies reveal significant geographic disparities in pediatric eye care availability. Some states have high concentrations of pediatric specialists, while others have few or none.

“We hope that this tool can be leveraged to minimize gaps in access to pediatric ophthalmic care,” said Stacy L. Pineles, MD, of the Jules Stein Eye Institute at the University of California, Los Angeles, and co-chair of the Pediatric Eye Disease Investigator Group (PEDIG).

ANDI is designed to assist any eye care professional through the diagnosis and management of amblyopia. Once a diagnosis is established, the tool provides evidence-based recommendations tailored to a child’s clinical findings. It helps clinicians determine the most appropriate eyeglass prescription and how long to monitor improvement with glasses alone—a strategy the NEI says can successfully treat up to one-third of children without additional interventions.

When glasses are insufficient, ANDI guides clinicians through next-step treatment options, including patching the stronger eye for several hours daily, using atropine eye drops to temporarily blur vision in the stronger eye, or considering newer digital therapies delivered through specially designed games and videos. The platform also offers recommendations for adjusting treatment when progress stalls, including increasing treatment intensity, switching therapies, reassessing prescriptions, or referring patients to specialists. Follow-up care guidance and strategies for monitoring recurrence after treatment completion are also included.

The tool can be used throughout a child’s treatment journey, from the initial visit through long-term follow-up care.

ANDI was developed by the Pediatric Eye Disease Investigator Group (PEDIG), an NIH-funded research network comprising more than 400 investigators. The tool is based on evidence synthesized from 147 published studies and is intended to make decades of amblyopia research readily accessible to clinicians in a practical, point-of-care format.

The tool is available free of charge at: https://public.jaeb.org/pedig/.

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Phase 3 Trial Evaluating Viridian's Veligrotug for Thyroid Eye Disease Published https://eyewire.news/news/phase-3-trial-evaluating-viridians-veligrotug-for-thyroid-eye-disease-publsihed Thu, 04 Jun 2026 13:04:56 GMT https://eyewire.news/news/phase-3-trial-evaluating-viridians-veligrotug-for-thyroid-eye-disease-publsihed Key Takeaways

  • Patients treated with the investigational IGF-1R antibody veligrotug achieved significantly greater improvements in active thyroid eye disease compared with placebo in the phase 3 THRIVE trial
  • Veligrotug demonstrated clinically meaningful benefits across key measures of disease activity, supporting IGF-1R inhibition as an effective targeted treatment strategy for TED
  • The FDA granted the application Priority Review and set a Prescription Drug User Fee Act (PDUFA) target action date of June 30, 2026 for the treatment

A novel biologic therapy may expand treatment options for patients with thyroid eye disease (TED), according to results from the phase 3 THRIVE trial published in Ophthalmology.1

Researchers reported that Viridian Therapeutics' veligrotug, a fully antagonistic monoclonal antibody targeting the insulin-like growth factor-1 receptor (IGF-1R), demonstrated significant efficacy and a favorable safety profile in patients with active TED. 

The THRIVE trial was designed to evaluate whether blocking IGF-1R signaling with veligrotug could reduce the inflammatory and tissue-remodeling processes that drive TED. Investigators assessed both efficacy and safety outcomes in patients with active disease.

In the trial, adult patients with moderate-to-severe active TED (onset ≤ 15 months, proptosis ≥ 3 mm above normal, and clinical activity score [CAS] ≥ 3) were randomized 2:1 to receive 10 mg/kg veligrotug or placebo administered every 3 weeks for a total of 5 IV infusions. A total of 113 patients received veligrotug (n = 75) or placebo (n = 38).

Improvements were observed at week 3, with a significantly greater response at week 15 for veligrotug versus placebo (< 0.001) across all primary and secondary end points including: PRR by Hertel, 70% versus 5%; PRR by magnetic resonance imaging (MRI) or computed tomography (CT), 71% versus 9%; ORR, 67% versus 5%; mean proptosis reduction, 2.90 mm versus 0.48 mm (Hertel) and 2.96 mm versus 0.58 mm (MRI/CT); diplopia improvement, 59% versus 20%; and diplopia resolution, 49% versus 12%. At week 52, 70% of initial responders maintained proptosis response.

Veligrotug was generally well tolerated, with a 4% treatment discontinuation rate. Most adverse events were mild and resolved, with no serious treatment-related adverse events and no changes in the safety profile through week 52.

According to the researchers, the results reinforce growing evidence that IGF-1R plays a central role in the pathophysiology of thyroid eye disease. By directly targeting this pathway, veligrotug may help address the underlying mechanisms driving inflammation, tissue expansion, and orbital changes associated with TED.

In December, Viridian announced that the FDA has accepted the Biologics License Application (BLA) for veligrotug for the treatment of TED. The FDA granted the application Priority Review and set a Prescription Drug User Fee Act (PDUFA) target action date of June 30, 2026.

Reference

1. Yen MT, Cockerham K, Saaed P, et al; THRIVE Study Group. THRIVE: a phase 3, randomized, double-masked, placebo-controlled trial of veligrotug in active thyroid eye disease. Ophthalmology. 2026. doi:10.1016/j.ophtha.2026.04.025.

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Study Examines Postoperative Complications Risk of LASIK and PRK https://eyewire.news/news/study-examines-postoperative-complications-risk-between-lasik-and-prk Wed, 03 Jun 2026 13:27:27 GMT https://eyewire.news/news/study-examines-postoperative-complications-risk-between-lasik-and-prk Key Takeaways

  • Patients who underwent LASIK experienced lower rates of postoperative dry eye disease, visual disturbances, and ocular symptoms compared with those who underwent PRK
  • The timing and incidence of complications differed between procedures, underscoring the importance of long-term follow-up and patient counseling 

A large national registry study has found that patients undergoing LASIK experienced lower rates of postoperative dry eye disease, visual disturbances, and other ocular symptoms compared with those receiving PRK, offering new insights into the long-term safety profiles of the two most commonly performed laser vision correction procedures.

In the study, published in The American Journal of Ophthalmology,1 researchers analyzed data from a national clinical registry to compare the incidence and timing of postoperative complications following LASIK and PRK. A total of 48,892 eyes of 27,372 patients who underwent refractive surgery in the IRIS Registry (Intelligent Research in Sight) were analyzed. The study focused on patient-reported and clinically documented outcomes, including dry eye disease, glare, halos, visual disturbances, and other ocular complaints that can affect quality of life after refractive surgery.

The findings showed meaningful differences in the frequency and timing of these complications between the two procedures. While both LASIK and PRK are widely regarded as safe and effective methods for correcting refractive errors such as myopia and astigmatism, the registry data suggest that LASIK patients generally experienced fewer postoperative ocular surface and visual symptoms over time.

Dry eye disease (DED) was the most frequently documented postoperative complication, occurring in 16.1% of LASIK eyes and 15.6% of PRK eyes over the follow-up period. During the 1 to 3 months interval, LASIK was associated with a lower incidence of DED compared with PRK (IRR, 0.8 [95% confidence interval (CI), 0.7-0.9]). In the first postoperative month, visual disturbances occurred more frequently after PRK (IRR, 0.3 [95% CI, 0.3-0.4]), but differences between procedures were not significant at later intervals. Ocular pain was rare after both procedures, with no consistent differences in early intervals, but showed a lower incidence after LASIK in the 3 to 12 months interval (IRR, 0.5 [95% CI, 0.3-0.9]).

The authors concluded that understanding the incidence and timing of postoperative complications can improve patient expectations and support more personalized refractive surgery planning. As laser vision correction continues to evolve, real-world registry data are increasingly being used to assess outcomes across large and diverse patient populations.

Reference

Kang S, Persad L, Woreta F, et al. Temporal Incidence of Dry Eye Disease, Visual Disturbances, and Ocular Pain After Laser-Assisted In Situ Keratomileusis Versus Photorefractive Keratectomy. Am J Ophthalmol. 2026;277:1-10. 

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New Four-Year Study Examines Faricimab's Durability in Diabetic Macular Edema https://eyewire.news/news/new-four-year-study-examines-faricimabs-durability-in-diabetic-macular-edema Tue, 02 Jun 2026 13:20:01 GMT https://eyewire.news/news/new-four-year-study-examines-faricimabs-durability-in-diabetic-macular-edema Key Takeaways

  • Four-year RHONE-X data showed faricimab maintained double-digit vision gains and substantial retinal drying in patients with DME
  • Treatment burden continued to decline over time, with approximately 80% of patients maintained on dosing intervals of 12 weeks or longer after 4 years 
  • Faricimab demonstrated a favorable long-term safety profile

Faricimab (Vabysmo; Genentech) continued to deliver durable visual and anatomical benefits for patients with diabetic macular edema (DME) through 4 years of follow-up, according to results from the phase 3 RHONE-X extension study published in Ophthalmology.1

The RHONE-X study enrolled 1,474 patients who completed the pivotal YOSEMITE and RHINE trials, making it one of the largest long-term extension studies conducted in DME. More than 1,200 patients completed the 2-year extension, representing an overall 4-year treatment experience for many participants.

Investigators reported that visual acuity gains achieved during the original YOSEMITE and RHINE studies were largely maintained throughout the extension period. At year 4, patients originally treated with faricimab gained between 10 and 11 ETDRS letters from baseline, while those who switched from aflibercept to faricimab maintained gains of approximately 9.5 letters.

Retinal anatomy improvements also remained robust. Central subfield thickness reductions exceeded 198 microns across all treatment groups at year 4, demonstrating sustained fluid control. More than 90% of patients achieved protocol-defined absence of DME by the end of the study, regardless of whether they had originally received faricimab or aflibercept.

During the 2-year RHONE-X extension, patients required a median of seven to eight injections. By the fourth year of treatment, approximately 80% of patients were being maintained on dosing intervals of at least 12 weeks, while more than 60% were receiving injections every 16 weeks.

Long-term safety findings were broadly consistent with previous faricimab studies. The incidence of intraocular inflammation was 1.3%, with no reported cases of retinal vasculitis or retinal occlusive vasculitis. Adverse events leading to treatment discontinuation occurred in just 1.5% of patients. Investigators reported low rates of treatment-related serious ocular adverse events, and most inflammation-related events were mild or moderate and resolved during the study period.

The authors concluded that faricimab's long-term efficacy, extended dosing intervals and favorable safety profile support its role in the chronic management of DME.

Reference

1. Sheth VS, Schlottmann P, Lai TYY, et al. Four-year outcomes of faricimab in diabetic macular edema: results from the RHONE-X extension trial. Ophthalmology. 2026;133(5):599-612. doi:10.1016/j.ophtha.2026.01.001.

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University of Miami Names Pradeep Y. Ramulu, MD, as Chair of Bascom Palmer Eye Institute https://eyewire.news/news/university-of-miami-names-pradeep-y-ramulu-md-as-chair-of-bascom-palmer-eye-institute Tue, 02 Jun 2026 12:57:33 GMT https://eyewire.news/news/university-of-miami-names-pradeep-y-ramulu-md-as-chair-of-bascom-palmer-eye-institute The University of Miami Miller School of Medicine has announced the appointment of Pradeep Y. Ramulu, MD, MHS, PhD, as chair of the Department of Ophthalmology and the Bascom Palmer Eye Institute, effective August 3, 2026. A globally respected glaucoma specialist, physician-scientist and educator, Dr. Ramulu returns to the institution where he completed his glaucoma fellowship and developed the foundation of his distinguished career in ophthalmology.

As chair, Dr. Ramulu will hold the prestigious Kathleen and Stanley J. Glaser Chair in Ophthalmology, succeeding Eduardo C. Alfonso, MD, who has led Bascom Palmer since 2007 and helped establish its reputation as the nation’s premier eye institute.

Dr. Ramulu joins Bascom Palmer after nearly two decades at the Wilmer Eye Institute at Johns Hopkins University, where he currently serves as the Sheila K. West Professor of Ophthalmology, chief of the Glaucoma Division and director of the Wilmer StARR (Stimulating Access to Research in Residency) Program. He is also a professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health.

“Bascom Palmer Eye Institute is truly the crown jewel of the University of Miami Health System, and the appointment of Dr. Ramulu as chair ensures that Bascom Palmer remains in the hands of a world-class leader who understands, from personal experience as a Bascom Palmer fellow, what makes this institution extraordinary,” said Dipen J. Parekh, MD, chief executive officer of UHealth — University of Miami Health System and executive vice president for health affairs at the University of Miami. “Dr. Ramulu’s vision, compassion and scientific expertise will carry Bascom Palmer’s legacy of excellence into a remarkable new chapter.”

A highly accomplished investigator, Dr. Ramulu has maintained continuous funding from the National Institutes of Health since 2007. He has authored more than 280 peer-reviewed publications, contributed 10 book chapters and written two books.

His numerous honors include the Secretariat Award, Achievement Award and Senior Achievement Award from the American Academy of Ophthalmology, as well as the Pisart Award for Vision Science. He has served as program chair for the American Glaucoma Society, Glaucoma Research Society and World Glaucoma Congress and currently leads the Education Committee for the World Glaucoma Association. He is also a mentor for the National Advisory Eye Council and is slated to become president of the American Glaucoma Society in 2027.

In addition to his research accomplishments, Dr. Ramulu is widely recognized for his contributions to medical education. An award-winning teacher, he has received Wilmer’s resident teaching award three times and pioneered innovative educational models that emphasize online learning and interactive, case-based instruction.

“Bascom Palmer is where my passion for glaucoma took root, and returning to lead this institution is both a profound honor and a personal homecoming,” Dr. Ramulu said. “I believe deeply that excellence in clinical care, the discovery of transformative new knowledge and training the next generation of physicians and scientists are all part of a single mission: to work toward a world where blindness and visual impairment are vanishingly rare, both here in Miami and throughout the world.”

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TearSolutions Receives FDA Orphan Drug and Fast Track Designations for Lacripep in Neurotrophic Keratitis https://eyewire.news/news/tearsolutions-receives-fda-orphan-drug-and-fast-track-designations-for-lacripep-in-neurotrophic-keratitis Tue, 02 Jun 2026 12:34:04 GMT https://eyewire.news/news/tearsolutions-receives-fda-orphan-drug-and-fast-track-designations-for-lacripep-in-neurotrophic-keratitis TearSolutions announced that the FDA has granted both Orphan Drug Designation (ODD) and Fast Track Designation to its lead investigational therapy, Lacripep, for the treatment of neurotrophic keratitis (NK). The company also announced the initiation of its phase 2 clinical trial, with the first patients now dosed.

“Receiving both Orphan Drug and Fast Track designations from the FDA is a significant milestone that underscores the unmet medical needs that still exist in neurotrophic keratitis and the potential for Lacripep to transform how this disease is treated,” said Anil Asrani, Chief Executive Officer of TearSolutions. “These designations validate our approach and afford us the opportunity to work closely with the FDA to accelerate our clinical development and bring this much-needed therapeutic option to patients sooner.”

The newly initiated phase 2 clinical trial is a multicenter, randomized, vehicle-controlled study designed to evaluate the safety and efficacy of Lacripep in patients with NK. Approximately 54 participants are expected to be enrolled across study sites in the United States. If successful, Lacripep could offer a novel therapeutic option for patients suffering from NK, a condition for which treatment choices remain limited.

Additional information about the study is available through ClinicalTrials.gov under identifier NCT07568730.

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State Investment to Fund first College of Optometry in Georgia https://eyewire.news/news/state-investment-to-fund-first-college-of-optometry-in-georgia Mon, 01 Jun 2026 18:54:42 GMT https://eyewire.news/news/state-investment-to-fund-first-college-of-optometry-in-georgia Georgia Southern University has secured nearly $40 million in state funding to advance several transformative projects, including the establishment of the state's first College of Optometry.

The funding, made through Georgia's Amended Fiscal Year 2026 Budget (HB 973), will support the renovation of the Highway 301 building in Statesboro, creating a facility designed to educate and train future doctors of optometry.

The College of Optometry is intended to address a growing demand for eye care professionals throughout Georgia, particularly in rural and underserved communities where access to vision care remains limited. By training optometrists within the state, Georgia Southern aims to strengthen Georgia’s healthcare workforce pipeline while improving long-term health outcomes for residents.

“Increasing access to quality, affordable healthcare in every corner of the state remains a top priority for the Georgia House, which is why we were proud to support this historic investment in our state’s first College of Optometry,” said House Speaker Jon Burns. “The future graduates of this institution will serve communities across Georgia, helping expand access to critical vision care that is so important to our quality of life, and strengthening our healthcare workforce for generations to come.”

In addition to expanding healthcare access, the college will create new educational opportunities for Georgia students interested in careers in vision care. Students will gain access to advanced academic preparation and clinical training experiences that previously required them to leave the state.

The proposed college will offer a Doctor of Optometry (OD) degree, pending approval by the University System of Georgia. The program must also complete accreditation processes through the Southern Association of Colleges and Schools Commission on Colleges and the Accreditation Council on Optometric Education before enrolling students.

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Bausch + Lomb Launches Preservative-Free Blink Triple Care Eye Drops in the US https://eyewire.news/news/bausch-lomb-launches-preservative-free-blink-triple-care-eye-drops-in-the-us Mon, 01 Jun 2026 13:22:01 GMT https://eyewire.news/news/bausch-lomb-launches-preservative-free-blink-triple-care-eye-drops-in-the-us Key Takeaways

  • Bausch + Lomb has launched Blink Triple Care Preservative Free in the US, offering preservative-free dry eye relief in a multi-dose bottle
  • The lipid-based formula combines natural oil and hyaluronate to create a dual-action moisture seal designed to help reduce tear evaporation and provide up to 10 hours of symptom relief
  • The product will be available nationwide by the end of June 2026 through major retailers 

Bausch + Lomb announced the US launch of Blink Triple Care Preservative Free, a new preservative-free dry eye drop designed to provide instant, long-lasting relief while offering the convenience of a multi-dose bottle.

According to B+L, the new product features the same clinically proven formula as Blink Triple Care and is designed to help reduce dryness, improve comfort and enhance vision quality. The preservative-free formulation also locks in moisture for extended hydration and provides up to 10 hours of relief from dry eye symptoms.

“Prolonged screen time and environmental factors are driving an increase in dry eye symptoms, and consumers are looking for products that fit their needs and preferences,” said John Ferris, president, Consumer, Bausch + Lomb. “Blink Triple Care Preservative Free provides another option within the Blink portfolio, offering the same trusted 3-in-1 extended relief as Blink Triple Care while further strengthening our position in dry eye.”

The lipid-based, preservative-free formula combines water-based hydration with a natural oil that helps prevent tears from evaporating too quickly. It also contains hyaluronate, a substance naturally found in the eye that supports hydration. Together, these ingredients create what the company describes as a dual-action moisture seal that helps lock in moisture, reduce tear evaporation and deliver sustained symptom relief.

The launch comes as dry eye disease and associated symptoms continue to affect a growing number of consumers, fueled in part by increased digital device use and environmental stressors. Preservative-free eye drops have gained popularity among patients seeking frequent-use options or those with sensitivities to preservatives commonly found in ophthalmic products.

Bausch + Lomb said Blink Triple Care Preservative Free will be available by the end of June 2026 in the eye care aisle and online through major US retailers, including Amazon, CVS, Target and Walgreens.

Additional information is available at JustBlink.com.

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Rayner Launches Optiesis Cohesive OVD in Europe https://eyewire.news/news/rayner-launches-optiesis-cohesive-ovd-family Mon, 01 Jun 2026 13:03:49 GMT https://eyewire.news/news/rayner-launches-optiesis-cohesive-ovd-family Rayner announced the launch of Optiesis Cohesive, a proprietary new ophthalmic viscosurgical device (OVD), marking an expansion of its OVD portfolio and surgical product offering.

According to the company, Optiesis Cohesive is formulated with a high-molecular-weight formulation designed to deliver strong viscosity and cohesiveness. The product contains 1.1 ml of sodium hyaluronate at a concentration of 2.9%, a formulation intended to provide enhanced space maintenance during cataract and other anterior segment procedures.

Rayner highlighted two key benefits of the new device: a larger volume than comparable products and room-temperature storage, eliminating the need for refrigeration and potentially simplifying inventory management for surgical centers.

The introduction of Optiesis Cohesive is accompanied by a broader rebranding of Rayner’s OVD family. The portfolio now includes:

  • Optiesis Cohesive – designed for strong space creation and stable anterior chamber maintenance with easy removal at the end of surgery
  • Optiesis Dispersive – intended to provide high retention and effective endothelial cell protection
  • Optiesis Adaptive PRO – a versatile, high-viscosity OVD containing 4% sorbitol, designed to combine space maintenance in the anterior chamber with endothelial cell protection during phacoemulsification and trauma cases

Ophteis Cohesive is CE marked and is now available in applicable markets, with further regions to follow subject to regulatory approval.

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Oculis Does Not Meet Primary Endpoint in Phase 3 DIAMOND Program of OCS-01 in DME https://eyewire.news/news/oculis-does-not-meet-primary-endpoint-in-phase-3-diamond-program-of-ocs-01-in-dme Fri, 29 May 2026 20:31:43 GMT https://eyewire.news/news/oculis-does-not-meet-primary-endpoint-in-phase-3-diamond-program-of-ocs-01-in-dme Key Takeaways

  • OCS-01 eye drops for the treatment of DME failed to meet the primary endpoint of improving best corrected visual acuity (BCVA) at Week 52 in both phase 3 DIAMOND-1 and DIAMOND-2 trials
  • OCS-01 demonstrated substantial and sustained reductions in retinal thickness versus vehicle across both studies
  • Based on the phase 3 results, Oculis does not plan to pursue an FDA regulatory filing for OCS-01 in DME 

Oculis' OCS-01 eye drops for the treatment of diabetic macular edema (DME) failed to meet the primary endpoint in two phase 3 trials.

The company announced topline results on Friday from its phase 3 DIAMOND-1 and DIAMOND-2 clinical trials evaluating OCS-01. The trials measured the mean change from baseline in best corrected visual acuity (BCVA) using the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score at Week 52. Both DIAMOND-1 and DIAMOND-2 did not demonstrate a statistically significant improvement in BCVA compared with vehicle control.

In addition, the key secondary endpoint assessing the proportion of patients achieving a gain of 15 or more ETDRS letters in BCVA was not met in either trial.

Despite the lack of visual acuity improvement, OCS-01 demonstrated a substantial and sustained reduction in retinal thickness, a key anatomical measure of disease activity. Optical coherence tomography (OCT) assessments showed consistent retinal thickness reductions compared with vehicle at all visits in DIAMOND-2 and at all visits except Week 52 in DIAMOND-1.

The DIAMOND (DIAbetic Macular edema patients ON a Drop) program consisted of two phase 3, double-masked, randomized, multicenter studies designed to assess the efficacy and safety of OCS-01 over a 52-week treatment period. More than 800 patients were enrolled across both pivotal trials at 119 investigational sites throughout the United States and several international locations.

The company reported that OCS-01 was generally well tolerated, with no unexpected adverse events observed during the studies. The safety profile remained consistent with findings from previous clinical trials.

As a result of the phase 3 outcomes, Oculis stated that it does not currently intend to pursue a FDA regulatory filing for OCS-01 as a treatment for DME.

“We are naturally disappointed that the substantial and sustained reduction in retinal thickness observed across both trials didn’t translate into BCVA improvement at Week 52,” said Riad Sherif, MD, Chief Executive Officer of Oculis. “In these two trials, our team partnered with 119 global sites across multiple countries and demonstrated excellent execution. We thank the patients, investigators, and all clinical experts who participated in the DIAMOND program.”

Dr. Sherif added that the company remains well positioned financially and plans to redirect resources toward other late-stage development programs.

“Our strong financial position allows us to execute on our robust late-stage development portfolio,” he said. “While we finalize the review of DIAMOND program data, we will strategically focus resources on advancing our late-stage portfolio, including the Privosegtor platform, starting with the PIONEER program for Privosegtor in optic neuropathies, and the PREDICT-1 trial for Licaminlimab to drive precision medicine in dry eye disease.”

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Study Finds Atopic Dermatitis May Raise Risk of Retinal Detachment https://eyewire.news/news/study-finds-atopic-dermatitis-may-raise-risk-of-retinal-detachment Fri, 29 May 2026 13:22:50 GMT https://eyewire.news/news/study-finds-atopic-dermatitis-may-raise-risk-of-retinal-detachment Key Takeaways

  • Adults with atopic dermatitis were nearly three times more likely to develop retinal detachment and more than four times more likely to undergo retinal detachment surgery than individuals without the condition
  • Patients with atopic dermatitis who underwent retinal detachment repair experienced higher rates of proliferative vitreoretinopathy
  • The findings suggest that chronic inflammation and behaviors such as frequent eye rubbing may contribute to elevated retinal risks in people with eczema

People living with atopic dermatitis—commonly known as eczema—may face a significantly higher risk of retinal detachment and complications following retinal surgery, according to new research published in Ophthalmology Retina.1

The large US-based study analyzed health records from hundreds of thousands of adults and found that patients with atopic dermatitis were substantially more likely to develop retinal detachment. Researchers from the Keck School of Medicine of the University of Southern California compared adults diagnosed with atopic dermatitis to matched individuals without the condition. After adjusting for demographic and health-related factors, the study included more than 274,000 patients in each group.

Over a 5-year period, 0.7% of patients with atopic dermatitis were diagnosed with retinal detachment, compared with 0.2% of those without the skin disorder. Patients with eczema were nearly three times more likely to develop retinal detachment and more than four times more likely to require surgical repair.

The study also found worse outcomes among eczema patients who underwent retinal detachment surgery. Individuals with atopic dermatitis had higher rates of proliferative vitreoretinopathy (PVR). Within six months of surgery, 5.9% of eczema patients developed PVR compared with 4.0% of patients without eczema. In addition, complex retinal repair procedures were more common among patients with atopic dermatitis, suggesting that the disease may contribute to more challenging surgical recoveries.

While the study does not prove that eczema directly causes retinal detachment, researchers believe several factors may help explain the association. Chronic inflammation linked to atopic dermatitis could affect retinal tissues and healing processes. Frequent eye rubbing—a common behavior among people with itchy skin around the eyes—has also been identified in previous research as a potential contributor to retinal damage.

“These findings suggest that [atopic dermatitis] may not only predispose individuals to retinal detachment, but may also contribute to worse surgical outcomes,” the authors wrote, noting that the condition may represent an underrecognized risk factor in eye care.

The researchers say additional studies are needed to better understand the biological mechanisms behind the link and to determine whether enhanced eye screening could benefit patients with chronic atopic dermatitis.

Reference

Hong AT, Yiu G, Hwang TS, et al. Association of atopic dermatitis with retinal detachment and postoperative proliferative vitreoretinopathy risk. Ophthalmol Retina. 2026;S2468-6530(26)00214-9. Published online May 18, 2026. doi:10.1016/j.oret.2026.05.006.

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Samsung Bioepis Launches Opuviz Aflibercept Biosimilar Across Europe https://eyewire.news/news/samsung-bioepis-launches-opuviz-aflibercept-biosimilar-across-europe Fri, 29 May 2026 12:33:00 GMT https://eyewire.news/news/samsung-bioepis-launches-opuviz-aflibercept-biosimilar-across-europe Key Takeaways

  • Samsung Bioepis has launched Opuviz, a biosimilar referencing Eylea (aflibercept), across Europe
  • Opuviz becomes Samsung Bioepis’ fifth directly commercialized biosimilar in Europe
  • The launch follows a January 2026 settlement and license agreement with Regeneron and Bayer

Samsung Bioepis announced today European launch of Opuviz (aflibercept) 40 mg/mL solution for injection in a vial, a biosimilar referencing Eylea (aflibercept).

The launch is effective today across Europe and represents Samsung Bioepis’ fifth biosimilar product to be directly commercialized by the company. Opuviz joins a growing portfolio of biosimilars that Samsung Bioepis has brought directly to the European market, including Byooviz (ranibizumab) 10 mg/mL solution for injection in a vial and Xbryk (denosumab) 120 mg solution for injection in a vial, which was launched in January.

“We are pleased to launch Opuviz in Europe, marking a significant milestone in expanding patient access to ophthalmology treatments,” said Antonio Rito, Vice President and Head of Europe at Samsung Bioepis. “Leveraging our direct commercialization capabilities, we will work closely with healthcare professionals and payers to facilitate access to this important medicine, so that patients can benefit from quality-assured, safe and effective biosimilar alternatives.”

The launch follows a settlement and license agreement announced in January 2026 between Samsung Bioepis, Regeneron, and Bayer concerning the commercialization of Samsung Bioepis’ biosimilar to Eylea 2 mg (aflibercept 40 mg/mL solution) in Europe and the rest of the world.

Beyond Europe, Samsung Bioepis’ aflibercept biosimilar is also available in the Republic of Korea under the brand name Afilivu.

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Therini Bio Doses First Patients in Phase 1b Trial of THN391 for DME https://eyewire.news/news/therini-bio-doses-first-patients-in-phase-1b-trial-of-thn391-for-dme Thu, 28 May 2026 12:49:31 GMT https://eyewire.news/news/therini-bio-doses-first-patients-in-phase-1b-trial-of-thn391-for-dme Key Takeaways

  • Therini Bio has dosed the first patients in a phase 1b clinical trial evaluating THN391, a fibrin-targeting monoclonal antibody for the treatment of DME, with initial data expected in 4Q 2026
  • THN391 is designed to selectively block fibrin-driven neuroinflammation without affecting normal coagulation, offering a potential new therapeutic approach for retinal diseases associated with vascular dysfunction and neurodegeneration.

Therini Bio announced that the first patients have been dosed in a phase 1b clinical trial evaluating THN391 for the treatment of diabetic macular edema (DME). The company also provided an update on its ophthalmology pipeline, including the selection of THN622, a fibrin/VEGF bispecific antibody candidate, for further development.

Therini’s lead ophthalmology candidate, THN391, is a potential first-in-class, high-affinity, humanized monoclonal antibody designed to selectively block fibrin’s inflammatory epitope while preserving normal blood coagulation. By targeting fibrin-driven inflammation, the therapy aims to interrupt the underlying neuroinflammatory cascade associated with retinal degeneration.

In a recently published study in the Journal of Neuroinflammation (Kantor et al., 2026), Therini demonstrated that THN391 was as effective as VEGF antagonists in containing leakage from neovascular lesions in preclinical models, supporting its potential as a novel therapeutic approach for retinal vascular diseases.

The ongoing phase 1b multiple ascending dose study is designed to evaluate the safety and preliminary efficacy of THN391 in patients with DME. The trial will include three dose cohorts, with each patient receiving three monthly intravitreal injections. In addition to safety assessments, the study will evaluate biological activity using endpoints including retinal central subfield thickness, visual acuity, and exploratory biomarkers. Initial data from the study is expected in the fourth quarter of 2026.

“The dosing of the first cohort of patients in our THN391 trial represents a significant milestone for Therini Bio,” said Joel Naor, MD, MSc., Chief Medical Officer, Ophthalmology at Therini Bio. “By targeting fibrin-driven inflammation, THN391 has the potential to enhance retinal health, improve treatment outcomes, and preserve vision in patients with DME. We look forward to evaluating the results of this trial and advancing THN622 toward the clinic.”

Therini also announced the advancement of THN622, a bispecific antibody targeting both fibrin’s inflammatory epitope and vascular endothelial growth factor (VEGF). The therapy is being developed for retinal conditions characterized by vascular dysfunction, including DME. THN622 combines VEGF blockade with a novel fibrin-targeting mechanism designed to address the underlying neuroinflammation that contributes to disease progression. Therini believes the dual mechanism could potentially improve treatment efficacy, increase response rates and durability, reduce fibrosis, and establish a new standard of care for neurodegenerative ocular diseases.

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Maculaser Secures New Investment to Advance Temperature-Controlled Retinal Laser Therapy in Europe https://eyewire.news/news/maculaser-secures-new-investment-to-advance-temperature-controlled-retinal-laser-therapy-in-europe Thu, 28 May 2026 12:30:27 GMT https://eyewire.news/news/maculaser-secures-new-investment-to-advance-temperature-controlled-retinal-laser-therapy-in-europe Key Takeaways

  • Maculaser has secured a new investment from M2care and Zeiss Ventures to accelerate the clinical development and commercialization of its personalized temperature-controlled retinal laser therapy
  • The company’s patented technology enables real-time retinal temperature monitoring during non-damaging laser treatment, aiming to intervene earlier in diseases such as AMD, DME, and CSC
  • M2care and Zeiss Ventures will provide strategic and operational support across clinical development, regulatory planning, manufacturing, and commercialization

Maculaser Oy announced a new undisclosed investment with the participation of M2care, a European healthtech venture studio, and Zeiss Ventures, the corporate venture capital arm of the Zeiss Group. The investment will support Maculaser’s progression toward clinical validation and commercial readiness of its temperature-controlled retinal laser therapy.

Founded in 2020 and rooted in pioneering research at Aalto University, Finland, Maculaser has developed a patented technology that enables real-time, personalized temperature control of the retina during non-damaging laser treatments.

Maculaser’s patented technology introduces a fundamentally different approach to treating retinal conditions: a non-damaging, temperature-controlled retinal laser treatment that activates the natural heat-shock defense mechanisms of retinal cells. By precisely monitoring and controlling retinal temperature in real time during each treatment, Maculaser says the system enables personalized therapy designed to target disease at earlier stages, before irreversible damage occurs.

Backed by M2care and Zeiss Ventures, Maculaser will now begin implementing the clinical development plan for its personalized retinal laser therapy. As part of the investment, M2care will support Maculaser with venture-building expertise across clinical development, regulatory strategy, financing preparation, and commercial planning.

The company said its immediate priority is to advance to first-in-human studies while continuing regulatory and manufacturing workstreams to support clinical validation and future use in ophthalmology clinics.

“This new collaboration marks an important moment for Maculaser,” said Jani Tirronen, CEO and Co-Founder of Maculaser. “With M2care and Zeiss Ventures joining us, we gain not only financial support but also strategic partners who bring deep expertise in healthtech and ophthalmic innovation. Together, we are well positioned to bring temperature-controlled retinal laser therapy to the clinic, where it can make a real difference for millions of patients.”

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Nanoscope Therapeutics Selects InspiroGene by McKesson to Support Distribution of Retinal Therapy https://eyewire.news/news/nanoscope-therapeutics-selects-inspirogene-by-mckesson-to-support-distribution-of-retinal-therapy Wed, 27 May 2026 15:10:23 GMT https://eyewire.news/news/nanoscope-therapeutics-selects-inspirogene-by-mckesson-to-support-distribution-of-retinal-therapy Nanoscope Therapeutics has selected InspiroGene by McKesson to provide US commercialization services for its lead product candidate, Mogenry, pending regulatory approval in the United States.

Under the agreement, InspiroGene by McKesson will provide specialty pharmacy, specialty distribution, and patient hub services to support the anticipated launch of Nanoscope’s retinal therapy in the US market. According to Nanoscope, the collaboration is intended to streamline commercialization and supply chain operations while helping deliver patient and provider support services as the company prepares for a potential commercial launch.

Mogenry is being developed as what Nanoscope describes as the first optogenetic gene therapy intended for the US market. The therapy is designed for patients with retinal degenerative diseases, including retinitis pigmentosa, a group of inherited disorders that can lead to progressive vision loss and blindness. Nanoscope's technology platform is designed to restore vision without requiring a surgical implant or light-intensifying device, potentially simplifying treatment administration in specialty care settings.

“Engaging with InspiroGene is an important step in our commercialization readiness planning,” said Sulagna Bhattacharya, CEO of Nanoscope Therapeutics. “InspiroGene’s experience in full-service patient support and its expertise across the U.S. healthcare system position them well to support efficient product delivery following regulatory approval.”

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Cure Blindness Project Releases 2025 Impact Report Highlighting Global Reach https://eyewire.news/news/cure-blindness-project-releases-2025-impact-report-highlighting-global-reach-and-restored-vision Wed, 27 May 2026 12:45:23 GMT https://eyewire.news/news/cure-blindness-project-releases-2025-impact-report-highlighting-global-reach-and-restored-vision

Cure Blindness Project announced the release of the Cure BlindnessProject 2025 Impact Report, which highlighted recent accomplishments in the global effort to eliminate avoidable blindness.

According to Cure Blindness Project, the report captures a period of unprecedented reach and impact, including more than 315,000 sight-restoring surgeries delivered across the organization’s global network, representing more than 1% of the world’s cataract blindness.

“It is always a true honor to announce our results. On behalf of our team and all our partners, we are excited and proud to share what we’ve accomplished together,” said K-T Overbey, CEO of Cure Blindness Project. “Our 2025 Impact Report reflects what has been our most impactful year to date—one defined not just by numbers, but by lives transformed.”

The report underscores how expanded access to care is changing lives—restoring independence, strengthening families, and revitalizing communities. From early-stage community screenings and treatments to advanced surgical care and follow-up services, Cure BlindnessProject continues to deliver comprehensive, patient-centered eye care where it is needed most.

In addition to direct service delivery, the report highlights the organization’s ongoing commitment to building sustainable eye health systems. Throughout 2025, Cure Blindness Project invested in training local clinicians, equipping partner facilities, and expanding community-based care—ensuring that high-quality services are accessible long after initial interventions.

“Our work goes beyond individual procedures,” Ms. Overbey added. “We are strengthening entire systems so that quality eye care becomes a lasting reality in the communities we serve.”

The 2025 Impact Report also offers a look at the organization’s work through photography and storytelling, bringing to life the resilience of patients and the dedication of providers on the front lines of care.

A full 2025 Annual Report, including financials and recognition of the donors and volunteers who make this work possible, will be released later this year. Cure Blindness Project emphasizes that none of this progress would be possible without the steadfast support of its global community of partners and donors.

The Cure Blindness Project 2025 Impact Report is available to view online at www.cureblindnes.org. 

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Outlook Therapeutics Wins FDA Appeal for Lytenava, Plans BLA Resubmission in June https://eyewire.news/news/outlook-therapeutics-wins-fda-appeal-for-lytenava-plans-bla-resubmission-in-june Tue, 26 May 2026 18:50:33 GMT https://eyewire.news/news/outlook-therapeutics-wins-fda-appeal-for-lytenava-plans-bla-resubmission-in-june

Key Takeaways

  • FDA’s Office of New Drugs determined that Outlook Therapeutics has established substantial evidence of effectiveness for Lytenava in treating wet AMD, clearing the way for a BLA resubmission in June 2026
  • The resubmission is expected to be classified as a Class 1 review, with a potential FDA decision anticipated within 60 days after the agency receives the application
  • If approved, Lytenava would become the first FDA-approved ophthalmic formulation of bevacizumab for retinal diseases in the US

After several setbacks, Outlook Therapeutics announced Tuesday that the FDA has granted the company’s appeal following a Formal Dispute Resolution (FDR) process tied to its biologics license application (BLA) for ONS-5010/Lytenava (bevacizumab-vikg), a proposed treatment for wet age-related macular degeneration (AMD).

The FDA’s Office of New Drugs (OND) concluded that Outlook Therapeutics has established “substantial evidence of effectiveness” for Lytenava in treating wet AMD, a major milestone that clears the way for the company to resubmit its BLA in June 2026.

The decision follows a December 30, 2025 Complete Response Letter (CRL) issued by the FDA regarding the company’s application. Outlook Therapeutics subsequently engaged in the FDR process after a Type A meeting with the FDA’s Division of Ophthalmology and Office of Specialty Medicine.

According to the company, the FDA's OND determined that data from the NORSE TWO clinical trial, combined with confirmatory evidence from NORSE EIGHT, natural history findings, and mechanistic and pharmacodynamic data, collectively demonstrated sufficient evidence of effectiveness for the therapy. The FDA also directed the Division of Ophthalmology and Office of Specialty Medicine to work with Outlook on final labeling discussions. The company said the agency anticipates the resubmission will qualify as a Class 1 review, which typically carries a 60-day review timeline from the date of receipt.

“We appreciate the opportunity to engage with the FDA through the FDR process,” said Bob Jahr, Chief Executive Officer of Outlook Therapeutics. “The Agency’s action on our appeal provides a clear path forward toward US approval ... We have remained resolute that patients deserve additional FDA-approved options for the treatment of nAMD and look forward to receiving an approval decision for ONS-5010/Lytenava."

If approved, Lytenava would become the first FDA-approved ophthalmic formulation of bevacizumab manufactured specifically for ophthalmic use and supported by FDA-approved labeling and pharmacovigilance protocols. Bevacizumab has long been used off-label in ophthalmology for retinal diseases, including wet AMD, but no ophthalmic formulation has yet received FDA approval in the United States.

The positive news comes after the FDA issued three CRL's to Outlook dating back to 2023. Outlook’s product is already authorized in Europe and the United Kingdom under the name Lytenava (bevacizumab gamma). The therapy has received centralized Marketing Authorization from the European Commission and approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of wet AMD. The company has also launched the product commercially in Germany, Austria, and the UK.

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Oculus Launches AI-Assisted Tool to Improve Meibomian Gland Dysfunction Diagnostics https://eyewire.news/news/oculus-launches-ai-assisted-tool-to-improve-meibomian-gland-dysfunction-diagnostics Tue, 26 May 2026 13:46:57 GMT https://eyewire.news/news/oculus-launches-ai-assisted-tool-to-improve-meibomian-gland-dysfunction-diagnostics

Key Takeaways

  • Meibo Analytics is a new AI-assisted decision-support tool from Oculus designed to help clinicians evaluate meibomian gland dysfunction (MGD) using meibography images from the Keratograph 5M
  • The software analyzes gland morphology according to the Arita grading scale, helping improve consistency and reproducibility in diagnosing dry eye-related gland changes.
  • Oculus says the technology is intended to support physician judgment by reducing uncertainty in early and intermediate stages of MGD assessment

Oculus has introduced "Meibo Analytics," a new artificial intelligence-assisted decision-support tool for the Keratograph 5M designed to help clinicians evaluate meibomian gland dysfunction (MGD).

The software uses AI-driven image analysis to quantify meibography images and support clinicians in interpreting structural changes in the meibomian glands.

According to Oculus, unlike functional tests alone, meibography provides structural insights into gland health that can help clinicians identify disease progression. However, interpreting these images can be subjective, particularly in the early and intermediate stages of MGD. Studies have shown variability in how clinicians interpret meibography findings, even among experienced examiners. Oculus said the challenge lies less in image acquisition and more in achieving consistent interpretation of results.

Meibo Analytics was developed to address those inconsistencies by applying AI-based structure analysis to meibography images. Integrated into the company’s JENVIS Pro Dry Eye Report, the tool is designed to evaluate gland morphology according to the Arita grading scale, assessing gland dropout and overall gland structure.

The company said the goal is not to replace physician judgment, but rather to provide a standardized and reproducible classification system that can reduce diagnostic uncertainty and improve confidence during evaluations.

By combining conventional meibography with automated image analysis, Meibo Analytics is intended to support more structured and consistent MGD diagnostics in routine clinical practice, Oculus stated.

More information about Meibo Analytics and the Keratograph 5M is available here.

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Researchers in Japan Link Drinking Habits to Faster Progression of Presbyopia https://eyewire.news/news/researchers-in-japan-link-drinking-habits-to-faster-progression-of-presbyopia Tue, 26 May 2026 13:24:25 GMT https://eyewire.news/news/researchers-in-japan-link-drinking-habits-to-faster-progression-of-presbyopia A new study suggests that alcohol consumption may speed up the progression of presbyopia, particularly in men. Researchers say the findings add to growing evidence that lifestyle habits can influence eye health as people age.

The study, published in Clinical Optometry, examined how drinking and smoking habits relate to presbyopia severity.1 

In the study, the near add power of 6,258 people aged 40 to 79 years was measured, and the association between lifestyle factors and near add power was analyzed. 

Researchers found that men who consumed alcohol showed signs of more advanced presbyopia compared with nondrinkers, even after accounting for age and other contributing factors. Logistic regression analyses showed that that male sex, drinking habit, myopic spherical equivalent, astigmatic errors, and a thin ganglion cell complex were common significant risk factors associated with near add power levels of 1.50 D and 2.50 D. Smoking status, HbA1c levels, and the presence of diabetic retinopathy were not significant factors. 

The authors noted that modern lifestyles may be amplifying the impact of near-vision problems. In today’s increasingly digital society, people spend much of their day focused on smartphones, tablets, and computers, placing additional strain on aging eyes.

While aging remains the primary cause, researchers say lifestyle-related factors may also play a role. Previous studies have linked smoking, diabetes, and poor metabolic health to worsening eye function, and the new research adds alcohol use as another possible contributor.

The researchers emphasized that the findings do not prove alcohol directly causes presbyopia. However, they said the results could help healthcare professionals educate patients about the broader effects of alcohol on long-term eye health.

Reference

1. Kaido M, Kawashima M, Toda I, Tsubota K. Drinking habit could exacerbate the progression of presbyopia in men. Clin Optom (Auckl). 2025;17:97-104. doi:10.2147/OPTO.S115043

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Hoya Vision Care Highlights Myopia Management Innovation and Clinical Education at EAOO 2026 https://eyewire.news/news/hoya-vision-care-highlights-myopia-management-innovation-and-clinical-education-at-eaoo-2026 Tue, 26 May 2026 12:47:02 GMT https://eyewire.news/news/hoya-vision-care-highlights-myopia-management-innovation-and-clinical-education-at-eaoo-2026 Hoya Vision Care showcased new research, clinical education initiatives, and real-world evidence in myopia management during the 17th Annual European Academy of Optometry and Optics (EAOO) conference, held May 15-17 in Riga, Latvia.

The company presented seven scientific papers, four posters, a hands-on workshop, and an educational lecture during the conference, while also announcing the Europe, Middle East, and Africa (EMEA) winner of its “Clinical Excellence in Myopia Management” MiYOSMART Case Study Contest. The activities followed the recent presentation of 12-month randomized controlled trial findings for MiYOSMART iQ at ARVO 2026, where researchers reported that 9 out of 10 children experienced no clinically relevant myopia progression during the first year of wear.¹˒²

The contest invited eye care professionals (ECPs) to submit patient cases involving MiYOSMART spectacle lenses in complex clinical settings, with the aim of fostering discussion around practical treatment approaches and contributing to a growing body of real-world evidence.

Three finalists were selected from submissions spanning 30 countries across the EMEA region: Dr. Stephanie Kearney of the United Kingdom, Dr. Vitaliya Zhurba of Kazakhstan, and Marion Wolff of France. 

Marion Wolff of Kirchberg Ophthalmology in Greater Strasbourg was named this year’s winner for presenting a 5-year clinical follow-up involving a young patient treated during the critical 8-to-12-year age window and with a strong family history of myopia.

As part of its educational programming, Hoya Vision Care also conducted a hands-on workshop introducing Hoyalux iD MySense, the company’s latest personalized progressive addition lens (PAL) technology. Delegates received practical experience using visuSense, Hoya’s measurement platform designed to assess each patient’s “Visual Sensory Intelligence” and optimize PAL customization.

Professor Fabrizio Zeri presented additional research examining adaptation outcomes among successful and unsuccessful progressive lens wearers.³

References

  1. Tse DYY, et al. Myopia Control Efficacy of Defocus Incorporated Multiple Segments Spectacle Lens with Triple Enhanced Design: a 12-month randomized controlled trial. Presented at the Association for Research in Vision and Ophthalmology (ARVO) 2026 Annual Meeting, May 3–7, 2026. Abstract 2523. Available at: https://eppro02.ativ.me/web/index.php?page=IntHtml&project=ARVO26&id=4486941. Accessed May 18, 2026.
  2. Hoya data on file. Hoya MiYOSMART iQ spectacle lens clinical outcomes. April 2026.
  3. Zeri F, et al. Adaptation outcomes with progressive addition spectacle lenses in previously successful and unsuccessful wearers. Presented at the 17th Annual European Academy of Optometry and Optics (EAOO) Conference, May 15–17, 2026, Riga, Latvia.
  4. Montani G, et al. Effect of Blue Light Attenuator Lenses on Visual Comfort, Visual Functions and Digital Eye Strain Symptoms. Presented at the 17th Annual European Academy of Optometry and Optics (EAOO) Conference, May 15–17, 2026, Riga, Latvia.
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CooperVision to Spotlight New Clinical Research at BCLA Asia 2026 https://eyewire.news/news/coopervision-to-spotlight-new-clinical-research-at-bcla-asia-2026 Tue, 26 May 2026 12:37:09 GMT https://eyewire.news/news/coopervision-to-spotlight-new-clinical-research-at-bcla-asia-2026 Key Takeaways

  • New CooperVision research at BCLA Asia 2026 highlights practical strategies to improve myopia management adoption, including stage-based parent education approaches designed to support long-term treatment adherence
  • A clinical study found no significant differences in fit or rotational stability when toric lens power was adjusted by ±1.00DC
  • Additional studies will examine multifocal contact lens fitting for presbyopia, including the impact of pupil size on vision performance and new clinical data related to MiSight 1 day lenses in Japan.

CooperVision will present new scientific research focused on myopia management, astigmatic lens fitting, and presbyopia during BCLA Asia 2026, taking place May 29-31 in Tokyo, in partnership with the Japan Contact Lens Society (JCLS).

The company said the studies are designed to provide eye care professionals (ECPs) with practical, evidence-based insights that can improve clinical decision-making and patient outcomes across a broad range of contact lens applications.

“Across the US, eye care professionals are looking for practical, evidence-based insights they can use right away with a diverse patient population,” said Jennifer Palombi, OD, FAAO, Director, Professional Affairs, Americas, CooperVision. “The studies CooperVision is presenting at BCLA Asia reinforce how research-driven innovation can support more confident clinical decision-making—from helping slow myopia progression in children to improving fitting efficiency for patients with astigmatism and presbyopia.”

One featured presentation, "Behaviour Change Insights: Leveraging the Transtheoretical Model to Guide Education in Myopia Management," examines how parents’ information needs evolve throughout their child’s myopia management journey.¹ Researchers analyzed more than 500 parent-related statements and mapped them to five stages of care: pre-contemplation, contemplation, preparation, action, and maintenance. The findings suggest that stage-matched communication strategies may improve parental understanding, encourage informed decision-making, and increase adoption and adherence to myopia management.

Another study, "Effect of Toric Power Alterations on Soft Toric Lens Fit and Rotation," evaluated whether varying toric power by ±1.00DC affected fitting characteristics in toric daily disposable contact lenses.² Conducted as a prospective, randomized, cross-over, open-label, controlled study involving 19 participants, the research found no significant differences in fitting patterns or axis orientation when toric power was altered within that range.

The findings may help ECPs reduce chair time and minimize the need for additional fittings before ordering exact prescriptions for astigmatic patients, according to CooperVision. The research was conducted in collaboration with the Optometry and Vision Science Research Group at Aston University and builds on earlier work presented at the 2026 Netherlands Contact Lens Congress.³

CooperVision scientists will also present research related to multifocal contact lens fitting for presbyopia, including investigations into the role of pupil size in optimizing visual performance and the earlier implementation of presbyopia management in Japan.⁴ Additionally, the company plans to share Japan-specific physiological and wearer experience data related to the recent launch of MiSight 1 day myopia control contact lenses in the country.

References

  1. Huang JC, Song T. Behaviour change insights: leveraging the transtheoretical model to guide education in myopia management. BCLA Asia 2026 Abstracts.
  2. Dutta D, Coates A, Olner C, Dhanabalan C, Sulley A. Effect of toric power alterations on soft toric lens fit and rotation. BCLA Asia 2026 Abstract.
  3. NCC. NCC ‘GET CONNECTED 2026’ paper abstracts (BCLA scientific stream). NCC 2026 abstract. Available at: https://www.contactlenscongress.com/mijnncc/uploads/abstracts/28_2026.pdf.
  4. Sulley A, Marullo R, Guillon M, Lazon de la Jara P. Does pupil size need to be considered when fitting a multifocal contact lens for optimal vision performance? BCLA Asia 2026 abstract.
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ViaLase Announces First Commercial FLIGHT Procedures in Europe https://eyewire.news/news/vialase-launches-first-commercial-flight-procedures-in-europe Tue, 26 May 2026 12:32:08 GMT https://eyewire.news/news/vialase-launches-first-commercial-flight-procedures-in-europe Key Takeaways

  • ViaLase has completed the first commercial FLIGHT glaucoma procedures in Europe using its incision-free ViaLuxe Laser System 
  • The procedures were performed at Centre for Sight in London by Sheraz Daya, MD, and Gus Gazzard, MD, and at Breyer, Kaymak & Klabe Augenchirurgie in Düsseldorf, Germany, by Karsten Klabe, MD
  • The FLIGHT procedure uses image-guided femtosecond laser technology and high-resolution OCT imaging to create precise channels through the trabecular meshwork

ViaLase announced the completion of the first commercial FLIGHT procedures in Europe. The procedures were performed at Centre for Sight in London by Sheraz Daya, MD, and Gus Gazzard, MD, and at Breyer, Kaymak & Klabe Augenchirurgie in Düsseldorf, Germany, by Karsten Klabe, MD.

The FLIGHT procedure was performed using the ViaLuxe Laser System, an incision-free, image-guided femtosecond laser platform designed to create precise channels through the trabecular meshwork to restore aqueous outflow and reduce IOP in patients with open-angle glaucoma.

“Centre for Sight has always been committed to bringing meaningful innovation to patients through technologies that advance precision, safety, and the overall treatment experience,” said Dr. Daya, Medical Director and Founder of Centre for Sight. “We are proud to be the first center globally to introduce the FLIGHT procedure, marking a redefinition of glaucoma care.”

“There remains a significant need for incision-free glaucoma treatment options that can be introduced earlier in the disease continuum,” Dr. Klabe said. “It is a privilege to be the first centre in Germany to bring the FLIGHT procedure into clinical practice.”

The ViaLuxe Laser System combines high-resolution optical coherence tomography (OCT) imaging with proprietary femtosecond laser technology to enable image-guided treatment delivery with micron-level precision.

“This marks an important milestone for ViaLase as we begin the commercial introduction of FLIGHT globally,” said Pete England, Chief Commercial Officer at ViaLase. “We believe this treatment has the potential to advance interventional glaucoma by enabling earlier, safer intervention to help patients reach target pressures and slow disease progression. ViaLase is proud to partner with globally respected thought leaders as we bring this technology into clinical practice.”

The company said it is supporting its initial European launch through a targeted network of distributor partners in select markets, including an exclusive distribution agreement with Carleton Optical in the United Kingdom.

The surgery marked the first commercial FLIGHT procedure in Europe. The technology received CE Mark in 2024. In the US, ViaLase is conducting a pivotal IDE trial structured to support future regulatory clearance and commercialization. 

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Zeiss Appoints Bronwyn Brophy O’Connor as Head of Medical Technology Segment and CEO of Carl Zeiss Meditec https://eyewire.news/news/zeiss-appoints-bronwyn-brophy-oconnor-as-head-of-medical-technology-segment-and-ceo-of-carl-zeiss-meditec Fri, 22 May 2026 14:31:30 GMT https://eyewire.news/news/zeiss-appoints-bronwyn-brophy-oconnor-as-head-of-medical-technology-segment-and-ceo-of-carl-zeiss-meditec

Carl Zeiss AG has appointed Bronwyn Brophy O’Connor as the new Executive Board Member responsible for the company’s Medical Technology segment, while the Supervisory Board of Carl Zeiss Meditec has named her Chief Executive Officer of the publicly listed medical technology company.

Andreas Pecher, President and CEO of Carl Zeiss AG, has served as interim CEO of Carl Zeiss Meditec AG since January 2026 and will continue in the role until Brophy O’Connor officially assumes her position. The exact start date remains subject to ongoing negotiations and will be announced at a later stage.

Ms. Brophy O’Connor currently serves as CEO of the Vitrolife Group, a Gothenburg, Sweden-based company listed on NASDAQ Stockholm in Sweden. She brings more than 25 years of international leadership experience across the medical technology and life sciences sectors.

Over the course of her career, she has held senior leadership positions at major multinational healthcare companies including Thermo Fisher Scientific, Medtronic, and Johnson & Johnson. Her professional experience spans several international markets, including the United Kingdom, Ireland, Switzerland, Spain, and the United States.

“With Bronwyn Brophy O’Connor, we are pleased to have found a successor who has excelled internationally,” said Michael Bolle, Chairman of the Supervisory Board of Carl Zeiss AG. “She has over 25 years of professional experience in medical technology and life sciences and, with her exceptional capabilities, will play a key role in shaping the ongoing realignment of Zeiss Medical Technology. We wish her a great start and all the best for her new position at Zeiss."

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Ingenia Therapeutics Receives Approval to Advance IPO in Korea https://eyewire.news/news/ingenia-therapeutics-receives-approval-to-advance-ipo-in-korea Fri, 22 May 2026 13:36:21 GMT https://eyewire.news/news/ingenia-therapeutics-receives-approval-to-advance-ipo-in-korea Key Takeaways
  • Ingenia Therapeutics received approval from the Korea Exchange (KRX) to proceed with its IPO, positioning the company to expand development of its vascular-targeted therapeutic platform
  • The company’s lead ophthalmology asset, MK-8748 (formerly IGT-427), is expected to enter phase 3 trials this year for wet AMD and diabetic macular edema through its partnership with Merck

Ingenia Therapeutics announced that it has received approval from the Korea Exchange (KRX) to proceed with its initial public offering (IPO). The IPO advancement comes as Ingenia continues to build momentum around its proprietary vascular biology platform and a growing pipeline of clinical-stage therapies targeting ophthalmology, nephrology, oncology, central nervous system (CNS), and cardiovascular diseases.

At the core of Ingenia’s technology is its breakthrough approach to directly activating the TIE2 signaling pathway—a mechanism designed to restore vascular stability and repair damaged endothelial barriers independent of traditional ligand balancing approaches involving Ang1 and Ang2. The company’s proprietary TIE-body and LCIDEC (Ligand Capture & Internalization into Endothelial Cells) platforms directly bind and activate the TIE2 receptor, helping “seal” endothelial cells and restore vascular barrier integrity in diseases driven by chronic inflammation and microvascular dysfunction.

Ingenia’s lead ophthalmology program, MK-8748 (formerly IGT-427 and also known as Tiespectus), is an investigational bispecific antibody targeting both VEGF and TIE2 pathways. The therapy is expected to enter phase 3 clinical development this year in both wet age-related macular degeneration (AMD) and diabetic macular edema (DME).

The asset is being developed by Merck following Ingenia’s 2022 research collaboration and licensing agreement with EyeBio, which became a wholly owned subsidiary of Merck after its acquisition in 2024. By combining VEGF inhibition with direct TIE2 activation to stabilize retinal vasculature, MK-8748 aims to improve outcomes beyond current standards of care for retinal disease patients.

“Targeting TIE2 remains one of the most compelling strategies for managing multiple retinal diseases, and the complexity of the pathway may have limited prior efforts,” said Charles C. Wykoff, MD, PhD, Director of Research at Retina Consultants of Texas and Chair of Research for Retina Consultants of America.

“Ingenia’s ability to trigger ligand-independent activation of the TIE2 pathway, while also inhibiting VEGF signaling, holds promise of becoming a clinical breakthrough,” Dr. Wykoff added. “As MK-8748 enters phase 3 trials this year, we are aiming to demonstrate a meaningful shift in how exudative retinal diseases can be managed, and uniquely stabilized.”

Ingenia Therapeutics is headquartered in Watertown, Massachusetts, with operations in South Korea and Australia. 

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IQity and Sightpath Medical Announce Strategic Partnership https://eyewire.news/news/iqity-and-sightpath-medical-announce-strategic-partnership-to-advance-the-future-of-ophthalmic-care Fri, 22 May 2026 13:14:24 GMT https://eyewire.news/news/iqity-and-sightpath-medical-announce-strategic-partnership-to-advance-the-future-of-ophthalmic-care Key Takeaways

  • IQity and Sightpath Medical are partnering to combine next-generation ophthalmic diagnostic and surgical technologies with a nationwide service and support infrastructure serving more than 1,000 facilities
  • The collaboration aims to accelerate market adoption of IQity’s upcoming innovations while ensuring dependable logistics, installation, and operational support for providers nationwide

IQity announced a strategic partnership with Sightpath Medical to create a comprehensive solution for surgeons and facilities seeking improved outcomes, greater efficiency, and lower operational costs, the companies announced. 

Financial terms of the deal were not disclosed. 

IQity’s integrated platform is designed to streamline and enhance the full ophthalmic workflow. The company expects to launch its first three flagship technologies in the near future:

  • IQ-SurgiView – A digital robotic surgical microscope featuring AI-assisted visualization
  • IQ-Meter – An all-in-one diagnostics and laser treatment device designed for premium lens surgery
  • IQ-Flow – A handheld, triple-action endoscopic cyclophotocoagulation (ECP) device intended to redefine glaucoma treatment

Through the partnership, these technologies will be supported by Sightpath Medical’s nationwide infrastructure, which currently serves more than 1,000 surgical facilities across all 50 states. Sightpath’s operational platform includes highly trained technicians and clinical staff, along with a mobile warehouse system stocked with cataract, glaucoma, and retina surgical equipment and supplies.

The collaboration is expected to provide physicians and facilities with enhanced reliability and service continuity, including Sightpath’s well-known emergency backup support capabilities.

“At IQity, our mission is to address the most pressing challenges in ophthalmology with technology designed to deliver superior visual outcomes, greater efficiency, and lower cost,” said Luke Clauson, CEO of IQity. “This partnership with Sightpath is a direct expression of that mission. We are bringing revolutionary ophthalmic technology to market through a service infrastructure that surgeons already trust.”

Yousuf Kalifa, MD, said the partnership represents a major step forward for the industry.

“By fusing IQity’s cutting-edge diagnostics and surgical interventions with Sightpath’s legendary operational efficiency, we are redefining the standard of ophthalmic care,” Dr. Kalifa said. “This partnership bridges the gap between the innovation pipeline and the operating room, delivering nimble, state-of-the-art technology through a proven framework of clinical excellence.”

“We are excited about the opportunity to work with the IQity team and leverage our expertise in logistics, installation and service to provide comprehensive inventory management and ongoing operational support as they introduce innovative technologies to the marketplace,” said Dan Robins, Chief Operating Officer at Finnitiv Health, Sightpath Medical’s parent company.

The partnership is effective immediately. For more information about IQity’s integrated ophthalmic platform, visit www.iqity.tech.

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Study Finds AI Shows Promise in Predicting Glaucoma Progression, but Clinical Gaps Remain https://eyewire.news/news/study-finds-ai-shows-promise-in-predicting-glaucoma-progression-but-clinical-gaps-remain Thu, 21 May 2026 12:44:47 GMT https://eyewire.news/news/study-finds-ai-shows-promise-in-predicting-glaucoma-progression-but-clinical-gaps-remain

A new systematic review published in npj Digital Medicine suggests that artificial intelligence could play a significant role in predicting glaucoma progression, potentially helping physicians identify patients at highest risk of vision loss earlier and more accurately. However, researchers caution that barriers remain before AI tools can be reliably implemented in routine clinical care.

The study analyzed 43 unique studies evaluating AI models designed to forecast glaucoma conversion, disease deterioration, and the need for surgery. According to the review, many AI systems demonstrated moderate-to-good predictive performance across several clinical endpoints, raising optimism that machine learning could help ophthalmologists personalize treatment strategies and identify high-risk patients sooner.1

The authors reviewed studies published since 2014 across MEDLINE, Embase, Web of Science, Cochrane CENTRAL, and arXiv databases. Two independent reviewers screened eligible studies and assessed risk of bias using the QUADAS-2 evaluation framework.

Despite encouraging findings, the researchers identified substantial weaknesses in the current body of evidence. Among the most significant concerns were inconsistent reporting standards, heterogeneity in study design, limited transparency in AI development, and poor generalizability across patient populations and healthcare settings.

The study noted that many models were trained and validated using narrow datasets, potentially limiting their ability to perform reliably in real-world clinical environments. The authors warned that without standardized methodologies and broader validation, AI systems risk underperforming when applied across diverse patient populations.

To address these shortcomings, the researchers proposed what they describe as the first glaucoma-specific set of recommendations aimed at improving study quality and accelerating clinical translation. The proposed framework emphasizes robust study design, transparent reporting, external validation, and improved interpretability of AI algorithms.

The authors argue that stronger reporting and validation standards will be critical if AI-based glaucoma prediction systems are to gain physician trust and regulatory acceptance.

Reference

1. Liang YG, Fan L, Teixeira-Pinto A, Liew G, White AJR. A systematic review of AI for predicting glaucoma progression: challenges and recommendations towards clinical implementation. npj Digit Med. 2026;9:Article 477. doi:10.1038/s41746-025-02321-7

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Lexitas Pharma Services Acquires Erie Retina Research, CASExERIE, and Element Erie Assets https://eyewire.news/news/lexitas-pharma-services-acquires-erie-retina-research-casexerie-and-element-erie-assets Thu, 21 May 2026 12:39:40 GMT https://eyewire.news/news/lexitas-pharma-services-acquires-erie-retina-research-casexerie-and-element-erie-assets Lexitas Pharma Services, a portfolio company of QHP Capital, has expanded its retina research capabilities through the acquisition of Erie Retina Research, CASExERIE, and the assets of Element Erie: Imaging & Reading Center PLLC.

Financial terms of the deal were not disclosed.

Erie Retina Research, in Erie, Pennsylvania, led by retina specialist and researcher David Almeida, MD, MBA, PhD, will operate as a wholly owned subsidiary of Lexitas. The transaction also includes the acquisition of CASExERIE, an ophthalmic innovation hub focused on advanced research, surgical training, and retina-focused product development, which will continue to operate within Erie Retina Research. In addition, Lexitas acquired the assets of Element Erie, a specialized imaging and reading center dedicated to the review and interpretation of ophthalmic imaging used in clinical trials.

The combined organizations are expected to create a fully integrated retina research ecosystem designed to accelerate ophthalmic innovation and improve efficiency across the clinical development process, according to Lexitas. By bringing together Lexitas’ clinical trial operations with Erie Retina Research’s scientific and investigative expertise, the partnership aims to strengthen the delivery of high-quality retinal clinical trials at a time of rapid growth in retinal therapeutics.

According to the company, the partnership is expected to deliver several strategic advantages, including expanded patient access across a broader range of retinal diseases, improved patient enrollment performance, and increased operational efficiency through integrated infrastructure and coordinated services.

The addition of CASExERIE is also expected to enhance Lexitas’ capabilities in surgical and medical device trials by providing specialized resources for surgical training, device evaluation, and procedural innovation. The organizations said the collaboration will further strengthen scientific leadership in retina development through integrated expertise supporting protocol design, clinical strategy, and scientific consultation from early-stage through late-stage clinical development.

As part of the transaction, Dr. Almeida, President and CEO of Erie Retina Research and founder of CASExERIE, will join Lexitas as Chief Retina Strategy Officer. In his new role, he will lead scientific and strategic development across the combined retina portfolio.

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Aflibercept Biosimilars Ahzantive and Baiama Now Available in the European Union https://eyewire.news/news/aflibercept-biosimilars-ahzantive-and-baiama-now-available-in-the-european-union Tue, 19 May 2026 15:35:35 GMT https://eyewire.news/news/aflibercept-biosimilars-ahzantive-and-baiama-now-available-in-the-european-union Formycon and its licensing partner Klinge Biopharma have jointly announced the commercial launch of FYB203, a biosimilar to Eylea 2mg (Regeneron) across the European Union.

The launch of the pre-filled syringe (PFS) presentations marketed under the brand names Ahzantive and Baiama officially began on May 15, 2026, in European markets including Germany, France, and Italy. According to the companies, the rollout will continue gradually across additional Central and Eastern European countries over the coming weeks and months through multiple commercialization partners.

“With the launch of Ahzantive and Baiama, we are reaching another important milestone in scaling our portfolio commercially,” said Nicola Mikulcik, Chief Business Officer of Formycon AG. “In line with our FYB4Growth strategy, we are positioning our biosimilar broadly across Europe’s diverse market landscape together with several strong licensing partners. This provides patients with severe retinal diseases with another safe, effective, and cost-efficient treatment option.”

The launch follows a March 2026 settlement and licensing agreement between Formycon, Regeneron, and Bayer Healthcare, which cleared the path for commercialization in Europe beginning May 15, 2026. Earlier, in October 2025, Formycon had secured the right to launch the biosimilar in the United States in the fourth quarter of 2026, or potentially earlier under certain conditions, through a separate agreement with Regeneron.

Ahzantive and Baiama are being introduced initially as pre-filled syringes. Formycon noted that vial presentations of Ahzantive and Baiama are expected to be introduced in selected European markets over the coming months.

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Becton, Dickinson and Company Names Peter Menziuso EVP and President, BD Interventional https://eyewire.news/news/becton-dickinson-and-company-names-peter-menziuso-evp-and-president-bd-interventional Tue, 19 May 2026 14:56:05 GMT https://eyewire.news/news/becton-dickinson-and-company-names-peter-menziuso-evp-and-president-bd-interventional BD (Becton, Dickinson and Company), a global medical technology company, announced that Peter Menziuso has been named executive vice president and president, BD Interventional, effective June 1.

Mr. Menziuso spent more than 30 years at Johnson & Johnson, where he most recently served as Company Group Chairman of Johnson & Johnson Vision. At J&J, he led a $5 billion global business with responsibility for commercial operations, research and development, supply chain, quality, finance and medical affairs.

According to BD, throughout his career, Mr. Menziuso has been recognized for strengthening market leadership, building high-performing teams and translating strategy into sustained performance through commercial rigor and operational excellence. 

“BD Interventional has a strong track record of performance, and Peter is the right leader to build on that momentum and continue delivering results,” said Tom Polen, chairman, CEO and president of BD. “Peter brings a strong combination of strategic leadership and operational discipline. He is grounded in delivering for customers and patients, building strong teams and driving consistent performance, positioning the business for sustained growth and continued strength across the portfolio.”

In his new role, Mr. Menziuso will oversee BD’s Interventional segment, which develops innovative technologies focused on advancing the treatment of peripheral vascular disease, cancer, urological and critical care conditions, and hernias. 

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The Vision Council Opens Registration for 2026 Lab Leadership Forum in Las Vegas https://eyewire.news/news/the-vision-council-opens-registration-for-2026-lab-leadership-forum-in-las-vegas Tue, 19 May 2026 14:30:44 GMT https://eyewire.news/news/the-vision-council-opens-registration-for-2026-lab-leadership-forum-in-las-vegas The Vision Council has opened registration for the 2026 Lab Leadership Forum, the organization’s flagship event for optical lab professionals, scheduled for Sept. 16-18, 2026, at the M Resort Spa Casino in Las Vegas.

The annual forum is designed exclusively for leaders within the independent optical lab network and will feature industry discussions, technical meetings, and networking opportunities focused on advancing the future of the optical lab sector. One of the event’s signature moments will be the presentation of the Goodfellow Award during a dinner ceremony on September 17. The award recognizes an individual who has made significant contributions to the optical community.

A full agenda is expected to be released in the coming weeks, with programming centered on professional development, innovation and strategies to support the long-term vitality of independent optical laboratories.

“The Lab Leadership Forum is one of the most valuable opportunities of the year for lab leaders to connect, share insights, and shape the future of the industry,” said Michael Vitale, vice president of Membership, Government Relations & Technical Affairs at The Vision Council. “We look forward to welcoming our members and colleagues to Las Vegas this September.”

Registration is now available, with discounted pricing offered for members of The Vision Council. Member registration is priced at $300, while non-member registration is $600.

An optional golf tournament will kick off the event on September 16 at noon PT and is available as a $195 add-on during registration.

The Vision Council also announced that it has secured special group room rates for attendees at the M Resort Spa Casino. Reservations must be made by August 19, 2026, to qualify for the discounted rate.

In addition, sponsorship opportunities are available for companies seeking exposure to optical lab decision-makers through event or golf tournament sponsorships. Interested organizations can contact Abigail Crosby, partnership and business development manager, at acrosby@thevisioncouncil.org for additional information.

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Bausch + Lomb Launches PreserVision AREDS3 Eye Vitamins in US https://eyewire.news/news/bausch-lomb-launches-preservision-areds3-eye-vitamins-in-us Tue, 19 May 2026 14:22:05 GMT https://eyewire.news/news/bausch-lomb-launches-preservision-areds3-eye-vitamins-in-us Key Takeaways

  • Bausch + Lomb announced the US launch of PreserVision AREDS3 eye vitamins
  • PreserVision AREDS3 combines clinically proven AREDS2 nutrients with a proprietary B-vitamin complex designed to support macular health in a broader range of people, including those in earlier stages of AMD.
  • Bausch + Lomb says the new eye vitamins provide “triple-action support” by helping protect macular health, nourish healthy cellular eye function and improve absorption of key nutrients

Bausch + Lomb announced the US launch of PreserVision AREDS3 eye vitamins, a new formulation designed to support macular health in a broader range of people, including those in earlier stages of age-related macular degeneration (AMD).

According to B+L, the new formula combines the clinically proven AREDS2 nutrients recommended by the National Eye Institute (NEI) with a proprietary B-vitamin complex, representing what the company calls its most advanced PreserVision formulation to date.

For decades, AREDS2-based nutritional supplementation has served as a cornerstone for helping reduce the risk of progression from moderate to advanced AMD. PreserVision AREDS3 builds on that foundation with the addition of research-backed B vitamins intended to support eye health earlier in the disease continuum and broaden nutritional support discussions between eye care professionals and patients, according to B+L.

“AMD affects millions of people, often long before symptoms meaningfully change day-to-day life,” said John Ferris, president, Consumer, Bausch + Lomb. “Historically, options to support macular health earlier in the condition have been limited. PreserVision AREDS3 reflects decades of research, and our commitment to advancing eye health through science, offering an option for a broader range of people looking to support their macular health.”

According to Bausch + Lomb, PreserVision AREDS3 is formulated to deliver “triple-action support” for macular health:

  • Protects: AREDS2 nutrients help protect macular health by neutralizing free radicals and replenishing the eyes’ natural filter
  • Nourishes: A proprietary B-vitamin complex — including vitamins B1, B2, B3, B5, B6, B7, B9 and B12 — is designed to promote healthy cellular eye function
  • Boosts: The formulation is designed to provide two times better absorption of key nutrients

The company said development of PreserVision AREDS3 was informed by more than two decades of scientific research examining the relationship between B vitamins and AMD. Evidence summarized in a recently published narrative review in Ophthalmology and Therapy evaluated findings from more than 20 human studies involving nearly 30,000 participants, including randomized clinical trials such as the Women’s Antioxidant and Folic Acid Cardiovascular Study. Researchers reported a statistically significant association between specific B-vitamin supplementation and reduced AMD risk.

Bausch + Lomb said the growing body of evidence influenced the inclusion of B vitamins in the AREDS3 formulation and will support future research, including plans for a long-term clinical trial evaluating the product.

PreserVision AREDS3 eye vitamins are now available nationwide in the eye care aisle and online through major retailers including Amazon, Target, Walgreens and Walmart. Additional information is available at www.preservision.com.

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SpyGlass Pharma Secures CPT Code for BIM-IOL System https://eyewire.news/news/spyglass-pharma-secures-ama-cpt-code-for-bim-iol-system Mon, 18 May 2026 15:02:17 GMT https://eyewire.news/news/spyglass-pharma-secures-ama-cpt-code-for-bim-iol-system Key Takeaways

  • The AMA approved a new add-on Category III CPT code (+X659T) for the attachment and insertion of SpyGlass Pharma’s investigational BIM-IOL System during routine cataract surgery
  • SpyGlass Pharma’s BIM-IOL System is designed to treat both cataracts and elevated IOP iin a single procedure by delivering bimatoprost continuously for up to 3 years
  • The company is currently conducting two phase 3 registrational trials, with enrollment expected to be completed in 2027 

SpyGlass Pharma announced that the American Medical Association’s (AMA) CPT Editorial Panel has approved a new add-on Category III CPT code for the attachment and insertion of an intraocular lens prosthesis-mounted drug-eluting implant. The application was submitted in support of SpyGlass Pharma’s investigational Bimatoprost Drug Pad-IOL System (BIM-IOL System), designed for use alongside standard cataract surgery procedures.

The newly approved code (+X659T), "Attachment and insertion of intraocular drug delivery implant," is intended for use in conjunction with established Category I cataract surgery CPT codes. Category III CPT codes are created to track emerging medical technologies and procedures, helping facilitate data collection and future reimbursement considerations.

“The approved Category III CPT code for attachment and insertion of the BIM-IOL System in conjunction with routine cataract surgery is an exciting moment in our path to product commercialization and reimbursement upon FDA approval,” said Patrick Mooney, Chief Executive Officer of SpyGlass Pharma. “In addition to breaking new ground clinically with the first-and-only product candidate addressing glaucoma and cataracts at the same time in a single intervention, we are excited to be breaking new ground on the commercial model with this additional supportive reimbursement pathway designed specifically for novel technologies like ours.”

The BIM-IOL System combines a standard IOL used in cataract surgery with proprietary non-bioerodible drug pads designed to continuously deliver bimatoprost over approximately 3 years. SpyGlass Pharma believes the system could address a longstanding challenge in glaucoma care: patient adherence to daily eye-drop regimens.

“The issuance of an add-on CPT code is an important milestone for all cataract surgeons interested in using the BIM-IOL System,” said Eric Donnenfeld, MD, Founding Partner of Ophthalmic Consultants of Long Island and former President of the American Society of Cataract and Refractive Surgery (ASCRS). “The potential for appropriate additional reimbursement associated with BIM-IOL System implantation is meaningful to our community and may further enable patient access to the BIM-IOL System.”

The company is currently evaluating the BIM-IOL System in two registrational phase 3 clinical trials involving patients diagnosed with OAG or OHT who also require cataract surgery. SpyGlass Pharma said enrollment in both studies remains on track for completion in 2027. In addition to the Phase 3 program, the company continues long-term follow-up from its earlier phase 1/2 clinical study assessing the safety and efficacy of the system.

SpyGlass Pharma stated it plans to continue working closely with the FDA as it advances toward completion of phase 3 trials, submission of a New Drug Application (NDA), and potential commercialization pending regulatory approval.

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Optivate Appoints Brad Caldwell as Chief Executive Officer https://eyewire.news/news/optivate-appoints-brad-caldwell-as-chief-executive-officer Mon, 18 May 2026 12:45:06 GMT https://eyewire.news/news/optivate-appoints-brad-caldwell-as-chief-executive-officer

Optivate, a provider of specialty-built software and solutions for ophthalmology practices, announced the appointment of Brad Caldwell as Chief Executive Officer. Abdiel Marin, company founder and current CEO, will transition into an advisory role while continuing to serve on the company’s Board of Directors.

Mr. Caldwell joins Optivate with experience in healthcare technology, go-to-market strategy, and operational leadership. In his new role, he will lead the company’s efforts to scale its platform, enhance customer outcomes, and accelerate innovation across its portfolio of ophthalmology-focused solutions.

“I’m honored to step into the role of CEO at such a pivotal time for Optivate,” said Caldwell. “The company has built a strong foundation with a clear mission—helping ophthalmology practices cut through complexity and focus on delivering exceptional care. I’m excited to work alongside this talented team to further expand our impact and continue delivering meaningful value to our customers.”

Under Mr. Marin’s leadership, Optivate established itself as a trusted partner to eye care providers nationwide, offering a suite of services spanning electronic health records (EHR), practice management (PM), revenue cycle management (RCM), and patient engagement solutions.

Optivate’s platform is specifically designed to address the unique operational and clinical needs of ophthalmology practices. The company said it emphasizes streamlined workflows, integrated systems, and customer-focused support to help providers reduce administrative burden and focus on patient outcomes.

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CooperVision Completes Enrollment in Landmark Global Myopia Control Studies https://eyewire.news/news/coopervision-completes-enrollment-in-landmark-global-myopia-control-studies Mon, 18 May 2026 12:36:46 GMT https://eyewire.news/news/coopervision-completes-enrollment-in-landmark-global-myopia-control-studies

CooperVision has completed enrollment in its global post-approval clinical studies (PAS) for MiSight 1 day, marking a milestone in the generation of real-world evidence for pediatric myopia control.

The US and China-based studies collectively represent what CooperVision says is the longest international clinical evidence program ever undertaken for soft contact lens-based myopia control intervention in children.1-3 The initiative includes randomized controlled efficacy trials alongside large-scale safety registries designed to evaluate long-term outcomes in real-world clinical settings.1,4-8

The combined PAS programs span more than 100 clinical sites and include over 3,000 participating children.9 According to the company, the findings will build upon an already extensive body of international clinical research surrounding MiSight 1 day, which has been widely published and cited throughout the ophthalmology and optometry communities.1, 4-8

Participants enrolled in the studies represent diverse pediatric populations across the United States and China, providing data intended to support broader global applications in myopia management. Final study results are expected to be released on a rolling basis between 2027 and 2030.

“As clinicians, we all want long-term, real-world data that mirrors how myopia control is actually practiced,” said Jennifer Palombi, OD, FAAO, Director, Professional Affairs, Americas, CooperVision. “Completing enrollment in these post-approval studies is an important step forward for our category. MiSight 1 day was built on a strong foundation of clinical evidence, and this next phase will add meaningful insights that can help eye care professionals (ECPs) feel even more confident when managing pediatric myopia and guiding families through long-term care decisions.”

In conjunction with the enrollment milestone, CooperVision also released a new report titled "Progress in Focus: The Global Impact of MiSight 1 day." The publication compiles the expanding body of evidence surrounding the product and traces the evolution of the MiSight 1 day platform.

References:

  1. Chamberlain P et al. A 3-year Randomized Clinical Trial of MiSight® Lenses for Myopia Control. Optom Vis Sci. 2019; 96(8): 556-567. 
  2. Chamberlain P, et al. Long-term Effect of Dual-focus Contact Lenses on Myopia Progression in Children: A 6-year Multicenter Clinical Trial. Optom Vis Sci. 2022 Mar 1;99(3):204-212. 
  3. Chamberlain P, et al. Myopia Progression in Children on cessation of Dual-Focus contact lens wear: MiSight 1 day 7-year findings. Optom Vis Sci 2021;98:E-abstract 210049.
  4. CVI data on file, 2022. 
  5. Chamberlain, Arumugam, Jones, et al. Myopia Progression in Children wearing Dual-Focus Contact Lenses: 6-year findings. Optom Vis Sci 2020;97(E-abstract):200038]
  6. Chamberlain, Arumugam, et al. Myopia progression cessation of Dual-Focus contact lens wear: MiSight 1 day 7 year findings. Optom Vis Sci 2021;98:E-abstract 210049.]
  7. Woods J et al. Ocular health of children wearing daily disposable contact lenses over a 6-year period. CLAE 2021 Aug;44(4):101391.
  8. Sulley A et al. Experience and subjective responses for children switched from single vision to dual focus myopia control daily disposable contact lenses. BCLA paper presentation 2021.
  9. CVI data on file, 2026.
  10. Holden BA, Fricke TR, Wilson DA, et al. Global prevalence of myopia and high myopia and temporal trends from 2000 through 2050. Ophthalmology. 2016;123(5):1036-1042.

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AI Reshapes Retinal Disease Research, International Study Finds https://eyewire.news/news/ai-reshapes-retinal-disease-research-international-study-finds Fri, 15 May 2026 15:44:29 GMT https://eyewire.news/news/ai-reshapes-retinal-disease-research-international-study-finds Artificial intelligence is rapidly transforming ophthalmology research, with a surge in studies focused on retinal disease diagnosis, imaging, and personalized treatment strategies over the past decade, according to a new bibliometric analysis examining global trends in AI-driven eye care.1

The study analyzed more than 20 years of scientific literature to map the intellectual and collaborative landscape of artificial intelligence applications in ophthalmology, particularly in retinal disease management. Researchers found that publication activity accelerated dramatically after 2015, fueled by advances in deep learning and medical imaging technologies.

The findings suggest AI is moving beyond experimental algorithms and becoming a central force in modern retinal diagnostics.

Researchers identified deep learning, optical coherence tomography (OCT), and diabetic retinopathy as the most influential and rapidly expanding areas of investigation.

The analysis highlighted strong collaboration networks among leading universities and research institutions, particularly in North America and Europe. Among the most influential contributors were the University of London and the University of California System, both of which emerged as major hubs for AI ophthalmology research.

Co-authorship and citation mapping revealed that much of the field’s development has been driven by concentrated institutional partnerships and regional research clusters. Researchers said these collaborative networks have accelerated innovation but also raised concerns about unequal global participation in AI development.

According to the study, ophthalmology research has evolved significantly from early algorithm-focused experimentation toward more clinically oriented applications.

Emerging themes now include:

  • Explainable AI systems
  • Telemedicine integration
  • Personalized retinal diagnostics
  • Multimodal imaging analysis
  • AI-assisted therapeutic planning

The rise of explainable AI reflects growing concern among clinicians and regulators about transparency in machine learning systems used in healthcare.The research shows that ophthalmologists are increasingly seeking tools that not only produce accurate predictions but also provide understandable reasoning behind diagnostic decisions.

Despite rapid growth, researchers identified several major obstacles slowing widespread clinical adoption.

Key challenges include:

  • Limited real-world implementation studies
  • Unclear regulatory pathways
  • Data privacy concerns
  • Bias in training datasets
  • Underrepresentation of low-resource regions

The study emphasized that much of the existing AI research has been conducted using datasets from high-income countries, potentially limiting the effectiveness of algorithms in more diverse global populations. Researchers warned that without broader representation and equitable deployment strategies, AI technologies could widen disparities in access to eye care rather than reduce them.

The authors concluded that future research should focus not only on improving algorithm performance but also on ensuring that AI systems are interpretable, clinically practical, and accessible across diverse healthcare settings.

Reference

1. Zhao R, Gillani S. AI in ophthalmology: a bibliometric analysis of retinal imaging research. Digital Health. 2026. doi:10.1016/j.dhjo.2026.100125.

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Study Examines Safety and Efficacy of Clobetasol Propionate After Cataract Surgery https://eyewire.news/news/study-examines-safety-and-efficacy-of-clobetasol-propionate-after-cataract-surgery Fri, 15 May 2026 12:52:40 GMT https://eyewire.news/news/study-examines-safety-and-efficacy-of-clobetasol-propionate-after-cataract-surgery A new clinical study suggests that a high-potency steroid eye drop may significantly reduce inflammation and pain following cataract surgery.1

Researchers reported that clobetasol propionate ophthalmic suspension 0.05% (CPN 0.05; Byqlovi, Harrow) successfully controlled postoperative inflammation and discomfort in patients recovering from cataract procedures, while maintaining a favorable safety profile. The findings were published in Ophthalmology, the journal of the American Academy of Ophthalmology. 

Researchers examined two multicenter, randomized, double-masked, placebo-controlled phase 3 trials (CPN-301 and CPN-302), identical in design except for a corneal endothelial cell (EC) safety sub-study in CPN-302. Post surgery, participants were randomized to CPN 0.05% (N=366) or placebo (N=382) instilled 1 drop twice daily (BID) for 14 days into the operated eye. 

CPN 0.05% met the primary endpoints, producing rapid and sustained clearance of inflammation and absence of ocular pain that was statistically significantly greater than placebo. At post-operative day 15, 58.2% of CPN 0.05% participants and 17.3% of placebo participants had an anterior chamber cell count of 0 (P<0.001), and 88.5% of CPN 0.05% participants and 45.8% of placebo participants had an ocular pain grade of0 (p<0.001). By post-operative day 4, visual acuity had improved more rapidly on CPN 0.05% than on placebo (p<0.001).

CPN 0.05% was well-tolerated with a safety profile similar to placebo. There were no meaningful IOP increases or corneal endothelial cell changes in CPN 0.05%-treated participants.

The authors noted that additional real-world studies may help determine how the treatment compares with other commonly prescribed steroid eye drops in routine ophthalmology practice.

In June 2025, Harrow and Taiwan-based Formosa Pharmaceuticals announced a licensing agreement in which Harrow acquired the exclusive US commercial rights for Byqlovi.

Reference

1. Berdahl JP, Holland EJ, Lindstrom RL, et al. Clobetasol propionate ophthalmic suspension 0.05% for the treatment of ocular inflammation and pain after cataract surgery. Ophthalmology. 2026;S0161-6420(26)00303-9. doi:10.1016/j.ophtha.2026.03.039.

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Study Finds 7 mL Peribulbar Block Safe and Effective as an Anesthesia in Ophthalmic Surgery https://eyewire.news/news/study-finds-7-ml-peribulbar-block-safe-and-effective-as-an-anesthesia-in-ophthalmic-surgery Thu, 14 May 2026 20:10:30 GMT https://eyewire.news/news/study-finds-7-ml-peribulbar-block-safe-and-effective-as-an-anesthesia-in-ophthalmic-surgery Key Takeaways

  • A study evaluated the relationship between peribulbar block (PB) solution volume, change in IOP, and anesthesia effect to guide its use in ophthalmic surgical procedures.
  • The study authors found no statistically significant difference between the 4 mL and 7 mL PB groups in terms of IOP change.
  • The 7-mL PB group achieved a significantly higher surgeon satisfaction score.

A study published in the American Journal of Ophthalmology evaluated the relationship between peribulbar block (PB) solution volume, change in IOP, and anesthesia effect to guide its use in ophthalmic surgical procedures.

The study was a prospective, controlled, 1:1 randomized, interventional study carried out at two ambulatory surgical centers. It included male and female patients between age 18 and 79 years of age undergoing planned intraocular surgery with PB as the designated anesthesia modality. Prior to the scheduled ophthalmic surgery, the enrolled eye was randomized to either 4 mL or 7 mL block volume immediately before PB administration by one of the five anesthesiologists. A regimented 2-minute manual massage was performed by the same research assistant after every block. IOPs were measured before the block, immediately after the block, and after the manual massage, twice at each time point. Immediately after the completion of surgery, the surgeon was asked to fill out an anesthesia satisfaction sheet while staying masked to the block volume.

The study authors found no statistically significant difference between the two groups in terms of IOP change after the block or after the ocular massage; each group’s IOP decreased significantly after the massage. Moreover, the 7-mL group achieved a significantly higher surgeon satisfaction score.

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Tarsus Partners With John Cena on Demodex Blepharitis Awareness Campaign https://eyewire.news/news/tarsus-partners-with-john-cena-on-demodex-blepharitis-awareness-campaign Thu, 14 May 2026 16:34:29 GMT https://eyewire.news/news/tarsus-partners-with-john-cena-on-demodex-blepharitis-awareness-campaign Tarsus Pharmaceuticals is partnering with celebrity John Cena on a campaign to raise awareness of Demodex blepharitis. As part of this campaign, Cena will detail his own experience with Demodex blepharitis and lotilaner ophthalmic solution 0.25% (Xdemvy) the first FDA-approved treatment that directly targets and kills the mites that cause Demodex blepharitis.

“I suffered from eyelid redness, itching and crusting for years, chalking it up to long days on set under bright lights,” said Cena. “But it finally got to the point where I couldn’t ignore it any longer. My eye doctor diagnosed me with Demodex blepharitis, and I was relieved to finally understand what was causing my symptoms and to know there was an available treatment. After being prescribed Xdemvy, my eyelid mites were eliminated and my symptoms resolved. I’ve spent years pushing my body to the limit, but I hadn’t paid attention to my eye health. Now, I make eye exams a regular part of my routine.”

Demodex blepharitis can be diagnosed during a routine eye examination, when an eye care provider asks the patient to look down to examine the eyelid margin for the presence of collarettes (ie, crusting).

The campaign will roll out in the coming months via media interviews and social content highlighting Cena’s experience with eyelid mites, his experience with Xdemvy, and his commitment to eye health.

“Too often, people ignore or even accept common eye symptoms like redness, itching and irritation, without realizing they may signal an underlying, treatable condition,” said Bobby Azamian, MD, PhD, Chief Executive Officer and Chairman of Tarsus. “John’s story is relatable to millions who often overlook or neglect their eye health, and his candid perspective and understated humor help bring attention to a significant disease. Regular eye examinations are critical, and we hope his experience encourages more people to recognize the signs, seek care and take their eye health seriously.”

For more information about Demodex blepharitis and Xdemvy, visit www.XDEMVY.com.

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CooperVision Completes National Campaign on Childhood Myopia https://eyewire.news/news/coopervision-completes-national-campaign-on-childhood-myopia Thu, 14 May 2026 13:36:32 GMT https://eyewire.news/news/coopervision-completes-national-campaign-on-childhood-myopia Key Takeaways

  • CooperVision launched a nationwide media campaign focused on raising awareness about childhood myopia and promoting early diagnosis, intervention, and proactive treatment.
  • The campaign was led by Damaris Raymondi, OD, and Coralys Vega, MD, who discussed the rise in pediatric myopia and emphasized coordinated care across optometric and pediatric health settings.
  • The media tour highlighted clinically proven treatment options, including MiSight 1 day contact lenses (Essilor), and reached 22 US markets through 26 interviews across television and radio in both English and Spanish.

CooperVision conducted a nationwide media tour on Wednesday, May 13, as part of its continued commitment to advancing awareness and management of childhood myopia. Led by Damaris Raymondi, OD, and Coralys Vega, MD, (Figure) the initiative brought together complementary clinical perspectives to reinforce myopia management as the emerging standard of care for children with progressive myopia, emphasizing the importance of early diagnosis, intervention, and proactive treatment.

Dr. Raymondi and Dr. Vega discussed the rise in pediatric myopia and the evolving standard of care in a series of live and recorded interviews that aired across major broadcast and radio outlets nationwide. Drawing from both optometric and pediatric care perspectives, they underscored the importance of early identification and coordinated care, while reinforcing that proactive myopia management should be considered a critical component of pediatric eye health care before progression accelerates.

They also highlighted clinically proven options such as MiSight 1 day contact lenses (Essilor)—the first FDA-approved soft contact lens indicated to slow the progression of myopia in children 8 to 12 years of age.

Highlights from these media engagements include:

  • 26 total interviews; 14 television and 12 radio (in both English and Spanish)
  • Coverage across 22 US markets, including Chicago, Miami, and Seattle

This marks CooperVision’s sixth consecutive year leveraging national media to elevate the conversation around pediatric myopia and support broader awareness of early intervention and treatment.

For more information, visit www.coopervision.com/myopia-management.

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Topcon Expands ARVO Presence with Record Research Activity https://eyewire.news/news/topcon-expands-arvo-presence-with-record-research-activity Thu, 14 May 2026 13:14:12 GMT https://eyewire.news/news/topcon-expands-arvo-presence-with-record-research-activity Key Takeaways

  • Topcon Healthcare increased its research presence at the 2026 ARVO meeting, with 80 accepted abstracts and 11 presentations.
  • The company emphasized the growing role of retinal imaging, AI, oculomics, and connected care in both ophthalmology and broader healthcare.
  • Topcon supported collaboration and education around AI-enabled healthcare through its symposium, “AI as the Bridge to Connected Care,” and by co-sponsoring the spring meeting of the Alliance for Healthcare from the Eye.

Topcon Healthcare announced a significant expansion of its scientific presence at the Association for Research in Vision and Ophthalmology (ARVO) 2026 conference, underscoring the role of ocular imaging, AI, oculomics, and connected care technologies in advancing ophthalmic research and broader health care innovation.

Topcon presentations have nearly tripled over the past 4 years, culminating this year with 80 accepted abstracts and 11 presentations across ARVO and the Imaging in the Eye scientific event. Topcon-related research was also presented among three ARVO Hot Topics recognitions, selected for their relevance to emerging areas shaping the future of medicine and vision research leveraging AI-based approaches.

“This continued growth reflects the increasing importance of advanced retinal imaging, AI, and connected care in driving scientific discovery,” said Daniela Ferrara, MD, PhD, Topcon Healthcare’s chief medical officer. “We are proud to empower researchers and clinicians with innovative technologies that enable deeper clinical insights, more data-driven decision-making, and new opportunities for earlier detection of vision-threatening and systemic diseases. The inspiring momentum at ARVO also reinforces the growing recognition that the eye can serve as a powerful, noninvasive window into overall health and healthy aging through the science of oculomics.”

As part of its ARVO 2026 activities, Topcon Healthcare hosted an educational symposium, “AI as the Bridge to Connected Care,” which explored the role of AI and advanced retinal imaging in identifying biomarkers for retinal, cardiovascular, metabolic, and neurodegenerative diseases. The program also highlighted the potential of AI-enabled endpoints, real-world data, and connected care models to transform clinical research and patient care.

Featured speakers included experts across clinical care, drug development, retinal imaging, AI, or digital health, including Daniela Ferrara, Michael Abramoff, Hasenin Al-khersan, Manjot Gill, Pearse Keane, David Rhew, and Ali Tafreshi.

Topcon Healthcare also co-sponsored the spring meeting of the Alliance for Healthcare from the Eye (AHE), a collaborative forum focused on advancing the responsible use of data, AI, and connected care models to improve disease detection, patient access, and health outcomes. The meeting brought together stakeholders committed to Healthcare from the Eye by exploring how insights from ocular data can contribute to the future of preventive, personalized, data-driven management of serious systemic and ocular diseases.

Together, Topcon Healthcare’s scientific presence at ARVO 2026, the “AI as the Bridge to Connected Care” symposium, and the Alliance for Healthcare from the Eye meeting reflect a broader shift in medicine, which is the growing recognition that the eye can provide critical insights into both ocular and systemic health.

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Zeiss Expands Cataract Surgery Portfolio in Mexico with Approval of Artevo 850 and Micor 700 https://eyewire.news/news/zeiss-expands-cataract-surgery-portfolio-in-mexico-with-approval-of-artevo-850-and-micor-700 Wed, 13 May 2026 15:37:29 GMT https://eyewire.news/news/zeiss-expands-cataract-surgery-portfolio-in-mexico-with-approval-of-artevo-850-and-micor-700

Zeiss announced that Mexico’s Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) has approved the Zeiss Artevo 850 ophthalmic microscope and the Zeiss Micor 700 lens extraction device for the Mexican market. Both technologies are fully compatible with the latest generation of Zeiss cataract workflow solutions.

The Zeiss Artevo 850 and Zeiss Micor 700 will be showcased at booth #A1 during the XXXVIII Mexican Congress of Ophthalmology (SMO), taking place in Monterrey, Mexico, May 30 to June 3, 2026.

The Zeiss Artevo 850 3D heads-up ophthalmic microscope is designed to advance digital surgical visualization through true-color imaging and an increased depth of field of nearly 60 percent. The platform integrates surgical devices and visualization technologies to help streamline clinical procedures and improve workflow efficiency. Through digital integration with Zeiss Ophthalmic Workflows, the system enables seamless data transfer across connected technologies. Additionally, the Zeiss Artevo 850 with Callisto eye features a redesigned touchscreen interface that centralizes controls for enhanced ease of use in the operating room.

The Zeiss Micor 700 introduces a new approach to lens extraction as the first hand-held lens removal device designed for ultrasound-free operation. Using the Zeiss NULEX (non-ultrasonic lens extraction) procedure, the system is intended to broaden the surgeon’s intraocular working space while helping minimize risk to surrounding ocular structures and improve operating room efficiency. The device’s blunt tip with rounded edges is engineered to be gentle on surrounding tissue and reduce the potential for tissue damage during surgery. Zeiss Micor 700 also incorporates a disposable “plug-and-play” system designed to support convenience, efficiency, and a minimal operating room footprint.

For more information about Zeiss ophthalmic workflow solutions in Mexico, visit the Zeiss booth during the XXXVIII Mexican Congress of Ophthalmology or visit the company online.

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NeuroVision Acquires Durin Life Sciences to Expand Neurodegenerative Disease Diagnostics Platform https://eyewire.news/news/neurovision-acquires-durin-life-sciences-to-expand-neurodegenerative-disease-diagnostics-platform Wed, 13 May 2026 13:34:30 GMT https://eyewire.news/news/neurovision-acquires-durin-life-sciences-to-expand-neurodegenerative-disease-diagnostics-platform Key Takeaways

  • NeuroVision Imaging acquired Durin Life Sciences to combine blood-based biomarker diagnostics with retinal imaging, telehealth, and patient engagement technologies for neurodegenerative disease care
  • The combined company plans to expand development and commercialization of diagnostic tools for Alzheimer’s disease, Parkinson’s disease, ALS, and related neurological disorders

NeuroVision Imaging announced it has acquired Durin Life Sciences. The deal aims to combine blood-based biomarker diagnostics with retinal imaging and telehealth capabilities to create an integrated platform focused on earlier detection and management of neurodegenerative diseases, according to the companies.

Financial terms of the transaction were not disclosed.

The combined company will continue operating under the NeuroVision name and remain led by Steven Verdooner, CEO and co-founder of NeuroVision. The acquisition brings together Durin’s Duritect blood-based diagnostic platform with NeuroVision’s retinal imaging technology, telehealth infrastructure, and BrainHealth.net patient engagement platform.

Company executives said the merger is designed to accelerate development and commercialization of diagnostic tools for Alzheimer’s disease, Parkinson’s disease, amyotrophic lateral sclerosis (ALS), and related neurological disorders.

“We’ve long believed that the future of neurodegenerative disease care begins with earlier and more accessible detection,” Mr. Verdooner said in a news release. “Durin’s blood-based biomarker platform represents an important advancement in that direction. By bringing together complementary strengths in diagnostics, technology and patient engagement, we believe we are uniquely positioned to help advance brain health at scale while supporting patients and families throughout the care journey.”

Durin Life Sciences developed Duritect, a suite of blood-based tests intended to support early detection and monitoring of neurodegenerative diseases. NeuroVision contributes its BrainHealth.net platform, which provides telehealth-enabled cognitive assessment, care navigation, and longitudinal brain health programs for patients and healthcare providers across the United States.

The companies said the integration of biomarker testing, imaging technologies, clinical infrastructure, and patient engagement tools could help improve access to earlier diagnosis and ongoing disease monitoring as demand for neurodegenerative care grows.

Ric Edelman, majority owner of Durin, will join the board of the combined company.

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Study: Popular GLP-1 Drugs Linked to Certain Optic Nerve Disorders https://eyewire.news/news/study-popular-glp-1-drugs-linked-to-certain-optic-nerve-disorders Wed, 13 May 2026 12:52:14 GMT https://eyewire.news/news/study-popular-glp-1-drugs-linked-to-certain-optic-nerve-disorders Key Takeaways

  • Patients with type 2 diabetes taking semaglutide or tirzepatide had a higher relative risk of developing a rare optic nerve disorder linked to sudden vision loss, though the overall risk remained very low
  • Researchers found cases of NAION occurred in 0.04% of patients using the GLP-1 drugs, compared with 0.02% of patients taking other diabetes medications
  • The study was observational and does not prove the drugs cause eye damage, but investigators say additional research is needed as use of GLP-1 medications continues to grow

Patients with type 2 diabetes who take the blockbuster weight-loss and diabetes drugs semaglutide or tirzepatide may face a slightly higher risk of developing certain optic nerve disorders, including nonarteritic anterior ischemic optic neuropathy (NAION), according to a large new study published in JAMA Network Open.1 The overall risk remained very low.

Researchers examined a population-based database of US patient electronic health records of more than 1.5 million patients from December 2017 to January 2023. Models were adjusted by propensity score matching. Eligible patients had type 2 diabetes and no prior diagnosis of eye disorders and were prescribed semaglutide, tirzepatide, or other antidiabetic medications. The study population comprised 159,398 matched patients with type 2 diabetes, including 79,699 patients in the semaglutide or tirzepatide group, and 79,699 patients in the comparison group. 

During the 2-year follow-up, there were 35 patients (0.04%) with NAION in the semaglutide or tirzepatide group and 19 patients (0.02%) with NAION in the matched comparison group (hazard ratio, 1.76 [95% CI, 1.01-3.07]). There were 93 patients (0.12%) with other optic nerve disorders in the semaglutide or tirzepatide group and 54 patients (0.07%) with other optic nerve disorders in the matched comparison group (hazard ratio, 1.65 [95% CI, 1.18-2.31]). No association was found with other disorders of the optic nerve or visual pathways.

NAION is considered the most common acute optic nerve injury in adults over 50. It occurs when blood flow to the optic nerve is reduced, potentially causing sudden and painless vision loss. Diabetes, obesity, hypertension, and sleep apnea are already known risk factors for the condition.

The research comes amid soaring use of GLP-1 receptor agonists, which have transformed treatment for obesity and diabetes because of their effectiveness in lowering blood sugar and promoting substantial weight loss. The drugs have also been associated with cardiovascular and kidney benefits.

Still, the findings add to growing scrutiny over potential side effects linked to the medications. Previous studies examining the connection between semaglutide and NAION have produced conflicting results, and a prior meta-analysis of randomized clinical trials did not find a clear association.

The authors cautioned that their study was observational and cannot prove the drugs directly cause optic nerve damage. They also noted limitations tied to electronic health record data, including possible diagnostic inaccuracies and the inability to measure medication adherence. Researchers said additional studies are needed to confirm the findings, determine whether some patients face higher susceptibility, and better understand the biological mechanisms involved.

Reference

1. Wang L, Volkow ND, Kaelber DC, Xu R. Semaglutide or Tirzepatide and Optic Nerve and Visual Pathway Disorders in Type 2 Diabetes. JAMA Netw Open. 2025;8(8):e2526327. doi:10.1001/jamanetworkopen.2025.26327.

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Balance Ophthalmics Receives FDA 510(k) Clearance for Wireless-Enabled Ocular Pressure Adjusting Pump for Glaucoma https://eyewire.news/news/balance-ophthalmics-receives-fda-510k-clearance-for-wireless-enabled-ocular-pressure-adjusting-pump-for-glaucoma Tue, 12 May 2026 15:24:58 GMT https://eyewire.news/news/balance-ophthalmics-receives-fda-510k-clearance-for-wireless-enabled-ocular-pressure-adjusting-pump-for-glaucoma

Balance Ophthalmics announced that the FDA has granted 510(k) clearance for a wireless-enabled, next-generation version of the FSYX Ocular Pressure Adjusting Pump (OPAP).

The clearance builds on the company’s previously granted De Novo classification for the FSYX platform, which was the first device specifically designed to reduce nocturnal IOP in glaucoma patients. The updated system introduces wireless communication capabilities, allowing eye care providers to access real-world patient usage data from at-home therapy.

FSYX (pronounced “physics”) remains the first and only non-pharmacological, non-surgical treatment designed to lower IOP during sleep in patients with glaucoma. The prescription-only system includes a compact pump connected to pressure-modulating goggles worn overnight to target a critical period when eye pressure often peaks and conventional therapies may provide less protection.

According to Balance Ophthalmics, FSYX demonstrated a 39% mean reduction in nighttime IOP across 12 clinical studies involving more than 600 eyes, with no device-related serious adverse events reported. The therapy is designed to complement existing glaucoma treatments, including medications and prior surgical interventions.

The newly cleared wireless functionality enables objective therapy adherence data to be transmitted directly to prescribing practices, offering clinicians greater visibility into patient engagement and treatment consistency.

“Many glaucoma patients progress at night when IOP runs highest and current therapies are least effective,” said Thomas W. Samuelson, MD, founding partner and attending surgeon at Minnesota Eye Consultants. “The OPAP is the first device designed to protect them during that window. The new wireless capability helps us detect, patient by patient, whether they’re actually receiving that protection while resting comfortably in their own home.”

Seph Jensen, CEO of Balance Ophthalmics, said the latest clearance represents a significant evolution of the company’s platform.

“Receiving 510(k) clearance for our next-generation FSYX OPAP builds directly on the foundation established with our De Novo classification,” Mr. Jensen said. “Wireless communication transforms the device into a connected clinical tool, giving practices insight into patient behavior at home. We are proud to bring this capability to glaucoma patients and the practices that care for them.”

Balance Ophthalmics said the new wireless FSYX OPAP system is expected to become available to eye care practices beginning in the fourth quarter of 2026.

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Astellas Presents New Izervay Data Showing Reduced Risk of Losing Driving Eligibility in GA Patients https://eyewire.news/news/astellas-presents-new-izervay-data-showing-reduced-risk-of-losing-driving-eligibility-in-ga-patients Tue, 12 May 2026 14:31:52 GMT https://eyewire.news/news/astellas-presents-new-izervay-data-showing-reduced-risk-of-losing-driving-eligibility-in-ga-patients Astellas announced new findings from a post hoc analysis of the GATHER1 and GATHER2 studies showing that treatment with Izervay (avacincaptad pegol intravitreal solution) reduced the risk of progressing to loss of driving eligibility in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The data were presented at the Association for Research in Vision and Ophthalmology (ARVO) annual meeting in Denver, Colorado.

The analysis evaluated 403 patients who were eligible to drive at baseline, defined as having a best-corrected visual acuity (BCVA) score of at least 70 ETDRS letters. Researchers assessed the risk of patients progressing to loss of driving eligibility, defined as a BCVA score of 60 letters or fewer at two consecutive post-baseline visits over a 24-month period.

At study initiation, patients treated with Izervay and those receiving sham treatment had comparable vision scores, averaging 76.2 and 76.0 letters, respectively.

By month 24, the risk of progressing to loss of driving eligibility was 12.6% among patients receiving Izervay either monthly (EM) or every other month (EOM), compared with 20.1% in the sham group. The results represented a 41% relative risk reduction for Izervay treatment, with a nominal P-value of 0.0594. Patients who transitioned from monthly dosing to every-other-month dosing demonstrated similar outcomes.

When researchers evaluated only the monthly dosing cohort against sham treatment, the risk of progressing to loss of driving eligibility was 15.1% for Izervay versus 20.1% for sham, reflecting a 35% relative risk reduction, though the nominal P-value of 0.1584 did not reach statistical significance.

Investigators emphasized that, because the analysis was exploratory and conducted post hoc, the findings should be interpreted cautiously and are not considered conclusive.

The GATHER1 study evaluated monthly Izervay dosing versus sham treatment over 18 months, while GATHER2 treated patients monthly for 12 months before re-randomizing them to monthly or every-other-month dosing through month 24.

In a separate oral encore presentation at ARVO, Astellas also shared results from the open-label extension (OLE) phase of the GATHER2 study. The company reported that Izervay remained well tolerated with no new safety signals identified. Investigators observed no cases of retinal vasculitis or occlusive vasculitis and no increased risk of intraocular inflammation.

Longer-term exploratory data from the GATHER2 OLE study further demonstrated sustained slowing of GA lesion growth over time, with earlier treatment associated with greater preservation of healthy retinal tissue.

Between months 24 and 42, mean GA lesion growth area was reduced by 40.5% versus projected sham in patients who switched from monthly or every-other-month dosing to monthly Izervay treatment at 3.5 years. In patients who initially received sham before transitioning to monthly Izervay, lesion growth was reduced by 37% versus projected sham. Both findings achieved statistical significance with p-values below 0.001.

Izervay is currently approved for the treatment of GA in the United States, Australia and Macau, and conditionally approved in Japan. Astellas said it continues to work with regulatory authorities globally to expand access to the therapy for GA patients worldwide.

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Study Finds Sequel Progressive Lenses Significantly Reduce Digital Eye Strain https://eyewire.news/news/study-finds-sequel-progressive-lenses-significantly-reduce-digital-eye-strain Tue, 12 May 2026 12:51:27 GMT https://eyewire.news/news/study-finds-sequel-progressive-lenses-significantly-reduce-digital-eye-strain Key Takeaways

  • A 6-week clinical study found that Sequel progressive addition lenses with Convergence Boost technology reduced digital eye strain symptoms by an average of 71% among participants
  • More than three-quarters of study participants reported no end-of-day eye fatigue, while 83% said the lenses were very comfortable for everyday tasks and extended screen use
  • Researchers say the technology differs from traditional progressive lenses by providing both accommodative and vergence support to address the visual demands of prolonged digital device use

Newton has released new findings from a 6-week prospective study showing that Sequel progressive addition lenses (PAL) with Convergence Boost technology significantly reduced symptoms of digital eye strain among participants.

The study comes as screen use continues to climb, with patients averaging more than 7 hours of screen time daily and nearly 70% experiencing symptoms associated with digital eye strain. According to the study, Sequel PAL—now available through VSP—delivered statistically significant and clinically meaningful improvements in digital eye strain symptoms after 6 weeks of wear.

  • Participants experienced an average 71% reduction in digital eye strain symptoms
  • 76% reported no end-of-day eye fatigue
  • 83% said Sequel PAL was very comfortable for performing everyday tasks

Newton said the findings reinforce the company’s ongoing commitment to developing clinically supported technologies designed to improve patient comfort and vision performance. The study also builds on recent research examining the impact of Neurolens technology on headaches and symptoms linked to eye misalignment. The results may have important implications for optometrists and eye care professionals seeking more effective solutions for patients who spend long hours on digital devices.

Unlike traditional progressive lenses that primarily provide accommodative support through added magnification power, Sequel PAL incorporates Convergence Boost technology designed to address both accommodative and vergence demands associated with extended screen use. Newton said this dual-support approach helps wearers maintain more comfortable vision during prolonged near work and digital tasks.

The 6-week study was conducted at six clinical sites across the United States and included participants age 40 and older who were already established progressive lens wearers and used digital devices for at least four hours daily.

Thirty participants enrolled in the study, with 29 completing the full 6-week evaluation period. Researchers used the Computer Vision Syndrome Questionnaire (CVS-Q) to measure symptom severity at baseline and at follow-up. The reported 71% reduction in digital eye strain reflected a drop in median CVS-Q scores from seven at baseline to two after 6 weeks of lens wear. Statistical analysis confirmed the improvement was significant at p < 0.05.

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AMA Unveils New Policy Framework to Combat AI “Deepfake” Impersonation of Physicians https://eyewire.news/news/ama-unveils-new-policy-framework-to-combat-ai-deepfake-impersonation-of-physicians Tue, 12 May 2026 12:37:16 GMT https://eyewire.news/news/ama-unveils-new-policy-framework-to-combat-ai-deepfake-impersonation-of-physicians Key Takeaways

  • The AMA has introduced a new policy framework aimed at protecting physicians from unauthorized AI-generated deepfakes that misuse their identities through fake images, videos, and audio
  • The framework calls for strict consent requirements, mandatory labeling of AI-generated content, rapid takedown mechanisms, and stronger enforcement powers for regulators and platforms
  • AMA leaders warn that physician impersonation deepfakes threaten patient safety, undermine trust in evidence-based medicine, and contribute to the spread of misleading or harmful health information

Responding to the growing threat of artificial intelligence-generated “deepfakes” that impersonate physicians, the American Medical Association (AMA) announced a sweeping new policy framework aimed at protecting doctors from unauthorized AI-generated images, videos, and audio.

Developed by the AMA Center for Digital Health and AI, the framework seeks to modernize physician identity protections, close legal loopholes, and strengthen safeguards for patient safety, professional integrity, and public trust in medicine.

“AI deepfakes that impersonate physicians are not just scams—they are a public health and safety crisis,” said AMA CEO John Whyte, MD, MPH. “When bad actors exploit a doctor’s identity, they undermine patient trust and can steer people toward harmful, unproven care. We need strong action by federal and state lawmakers to protect physicians’ identities, ensure transparency, and stop this fraud. Safeguarding professional integrity is essential to preserving trust and delivering high-quality care in a rapidly evolving digital landscape.”

The AMA warned that deepfake technology is increasingly being used to falsely portray physicians endorsing unproven treatments, fraudulent health products, and misleading medical information. The organization said such impersonation schemes not only threaten individual physicians but also erode public confidence in evidence-based medicine and the patient-physician relationship.

To confront the issue, the AMA’s framework outlines seven core policy principles designed to establish clearer legal protections and accountability standards across the health care and technology sectors.

Among the central proposals is the recognition that a physician’s identity—including their name, image, likeness, voice, and digital replicas—is a protected right that cannot be transferred or used without explicit, informed consent.

The framework also calls for a broad prohibition on deceptive AI-generated impersonations of physicians, particularly when content falsely suggests a doctor’s endorsement, authorship, or participation in medical messaging that could mislead patients.

The AMA is further advocating for strict opt-in consent requirements before any physician identity can be used in AI-generated content. According to the proposal, consent agreements should clearly define the intended use, audience, purpose, and duration of the content, while also allowing physicians to revoke permission if circumstances change.

Transparency measures are another key component of the policy blueprint. The AMA said all AI-generated or manipulated depictions of physicians should include plain-language disclosures and digital watermarks, with patients notified in advance before interacting with any synthetic or AI-generated medical professional representation.

Under the framework, responsibility for preventing impersonation would extend beyond physicians themselves. Technology platforms, hospitals, health systems, and AI vendors would share accountability for implementing safeguards, including rapid takedown procedures, conspicuous labeling standards, and restrictions on the misuse of professional medical titles.

The AMA also called for stronger enforcement mechanisms and practical remedies for physicians harmed by deepfake impersonation. Recommendations include preserving audit logs, improving coordination with investigations, empowering federal agencies to pursue enforcement actions, and requiring annual public reporting on impersonation incidents.

Finally, the organization emphasized that physicians should not bear the administrative burden of protecting their identities. The framework advocates for standardized, reusable consent systems and institutionally supported protections that make identity safeguards automatic rather than cumbersome.

The AMA said the new framework will guide its advocacy efforts with lawmakers, regulators, health care organizations, and technology companies as policymakers grapple with the rapid rise of generative AI tools.

The organization added that it stands ready to collaborate with government and industry leaders to establish enforceable standards that protect both physicians and patients from the growing dangers posed by AI-generated deception.

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Global Study Finds Accelerated Biological Aging Linked to Higher Cataract Risk https://eyewire.news/news/accelerated-biological-aging-linked-to-higher-cataract-risk-international-study-finds Mon, 11 May 2026 13:32:11 GMT https://eyewire.news/news/accelerated-biological-aging-linked-to-higher-cataract-risk-international-study-finds A new international study published in the British Journal of Ophthalmology suggests that accelerated biological ageing may significantly increase the risk of developing cataracts, offering fresh insight into why some people experience age-related vision decline earlier than others.1

The research, titled “Linking accelerated biological ageing to cataract susceptibility: evidence from cross-cohort analysis,” was published online on May 6 and examined associations between markers of biological aging and cataract development across multiple population cohorts. 

The research included people aged 40 and above with biological ages, including phenotypic age (PhenoAge), Klemera-Doubal method (KDMAge) and retinal age (RetiAge), from the US National Health and Nutrition Examination Survey (NHANES) and UK Biobank. The cross-sectional analyses were conducted to identify associations of PhenoAge or KDMAge acceleration with cataract and other blinding eye diseases using logistic regression. 

According to the investigators, individuals showing signs of accelerated biological aging appeared more susceptible to cataracts, supporting the theory that systemic aging processes may directly influence eye health. The study consisted of 5,433 people from the US NHANES and 269,615 people from the UK Biobank. In both cross-sectional and longitudinal analyses, accelerated biological aging was positively associated with an increased risk of cataract (all P<0.05). In a longitudinal cohort, RetiAge acceleration demonstrated the larger effect size estimates (HR 1.54 (95% CI 1.38 to 1.73)) compared with PhenoAge acceleration (HR 1.05 (95% CI 1.03 to 1.08)) and KDMAge acceleration (HR 1.06 (95% CI 1.04 to 1.08)). Only in the UK population, risks of glaucoma showed stronger links with KDMAge acceleration (HR 1.06 (95% CI 1.01 to 1.11)), while AMD showed more pronounced associations with PhenoAge acceleration (HR 1.08 (95% CI 1.02 to 1.14)).

The researchers say the study could have implications for preventive medicine and early screening strategies. If biological aging markers can reliably identify people at higher risk of cataracts, clinicians may eventually be able to intervene earlier through lifestyle changes, monitoring or targeted therapies. Researchers noted that further studies will be needed to determine whether slowing biological aging could reduce cataract risk or delay disease onset. 

Reference

1. Chi K, He Y, et al. Linking accelerated biological ageing to cataract susceptibility: evidence from cross-cohort analysis. Br J Ophthalmol. Published online May 7, 2026. doi:10.1136/bjo-2025-329061.

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Four-Year Study Suggests Faricimab May Reduce Injection Burden for Patients With Diabetic Macular Edema https://eyewire.news/news/four-year-study-suggests-faricimab-may-reduce-injection-burden-for-patients-with-diabetic-macular-edema Mon, 11 May 2026 13:07:43 GMT https://eyewire.news/news/four-year-study-suggests-faricimab-may-reduce-injection-burden-for-patients-with-diabetic-macular-edema

A long-term extension study published in Ophthalmology suggests that Roche’s retinal drug faricimab (Vabysmo) may help patients with diabetic macular edema (DME) maintain vision gains for up to 4 years while reducing the frequency of eye injections.1

The findings come from the RHONE-X extension trial, which followed patients who had completed the pivotal YOSEMITE and RHINE phase 3 studies. Researchers evaluated the long-term safety, durability, and effectiveness of faricimab using a personalized treat-and-extend (T&E) dosing strategy in people with DME.

Faricimab is distinct from older retinal therapies because it targets two disease pathways simultaneously—vascular endothelial growth factor A (VEGF-A) and angiopoietin-2 (Ang-2). 

Overall, 1204 patients (82%) completed the RHONE-X trial. The incidence of AEs leading to treatment discontinuation (1.5%) and rates of intraocular inflammation (1.3%) were low.

According to the study, most patients entering the extension phase were able to maintain extended dosing schedules over time. Adjusted mean BCVA improvements from YOSEMITE and RHINE baseline to the end of the RHONE-X trial were +10.1 letters (faricimab T&E), +11.4 letters (faricimab T&E [prior Q8W]), and +9.5 letters (faricimab T&E [prior aflibercept]); CST reductions were –198.3 μm, –202.5 μm, and –204.9 μm, respectively. At study end, more than 90% of patients achieved DME absence, regardless of prior treatment.

Median number of injections over the RHONE-X trial (2 years) were 7 (faricimab T&E), 8 (faricimab T&E [prior Q8W]), and 8 (faricimab T&E [prior aflibercept]). By the RHONE-X trial completion, approximately 80% of patients received faricimab at ≥Q12W intervals.

Safety findings remained consistent with previous faricimab studies, and no new safety concerns emerged during long-term follow-up.

Investigators said the RHONE-X data demonstrate that individualized treatment intervals with faricimab may provide durable disease control while easing the long-term burden of care for patients and healthcare systems alike.

1. Sheth V, Schlottmann P, Lai T, et al. Four-year outcomes of faricimab in diabetic macular edema: results from the RHONE-X extension trial. Ophthalmology. 2026;Published online ahead of print. doi:10.1016/j.ophtha.2026.01.004

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PulseSight Reports Positive Phase 1 Data for PST-611 Gene Therapy in Geographic Atrophy https://eyewire.news/news/pulsesight-reports-positive-phase-1-data-for-pst-611-gene-therapy-in-geographic-atrophy Mon, 11 May 2026 12:40:19 GMT https://eyewire.news/news/pulsesight-reports-positive-phase-1-data-for-pst-611-gene-therapy-in-geographic-atrophy Key Takeaways

  • PulseSight Therapeutics reported positive phase 1 results for PST-611, a first-in-class gene therapy for geographic atrophy, demonstrating excellent safety and tolerability 
  • Although the trial was primarily designed to assess safety, investigators observed encouraging early efficacy signals
  • PulseSight plans to launch a repeat-dose phase 2a trial in up to 20 patients in H2 2026

PulseSight Therapeutics announced positive results from its phase 1 clinical trial evaluating PST-611 in patients with geographic atrophy (GA).

The findings from the first-in-human PST-611-CT1 study were presented in a podium session at the ARVO 2026 Annual Meeting.

According to PulseSight, PST-611 is a first-in-class gene therapy candidate designed to restore iron balance by encoding transferrin, a natural iron transporter critical to iron homeostasis. The PST-611-CT1 trial evaluated the safety and tolerability of two ascending dose levels of PST-611 in six patients across two sequential cohorts. Patients were monitored over a 16-week follow-up period.

The study was conducted in Paris and Grenoble under the leadership of Professor Francine Behar-Cohen, MD, PhD, at the Department of Ophthalmology, Cochin – Assistance Publique-Hôpitaux de Paris (AP-HP), and Professor Christophe Chiquet, MD, PhD, at the Department of Ophthalmology, CHU Grenoble Alpes.

According to the company, the trial met both its primary and secondary objectives, demonstrating an excellent safety and tolerability profile at both dose levels. Most ocular adverse events were mild, while two were classified as moderate. Investigators reported no intraocular inflammation, no treatment-emergent serious adverse events (SAEs), and no suspected unexpected serious adverse reactions (SUSARs). Best Corrected Visual Acuity (BCVA) remained stable throughout the study.

Although the study was not designed to evaluate efficacy, investigators observed early signals suggesting potential therapeutic benefit. These included spontaneous patient reports of vision improvement and anatomical indications of slowed GA lesion growth. In one patient, the observed efficacy signal reportedly persisted beyond the official study follow-up period.

“Geographic atrophy is a progressive, sight-threatening disease with no effective treatment currently available in Europe — the unmet medical need is real and urgent,” said Professor Behar-Cohen. “These Phase 1 results are therefore particularly meaningful. PST-611 demonstrated excellent tolerability, which is fundamental when treating patients with a chronic condition. What makes these results stand out are the early efficacy signals we observed, both anatomically and functionally.”

She added that the planned Phase 2a study would help determine the therapy’s potential in a larger patient population over a longer observation period.

PulseSight has submitted a Clinical Trial Authorization (CTA) application to the French regulatory authority, Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM), for the upcoming PST-611-CT2 study. The Phase 2a trial is designed to evaluate the safety and explore the efficacy of three administrations of high-dose PST-611 over 52 weeks in up to 20 patients across three clinical sites. Pending regulatory approval, patient enrollment is expected to begin in the second half of 2026, with topline results anticipated in 2028.

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Drug Farm Presents Phase 1b DF-003 Data in ROSAH Syndrome at ARVO https://eyewire.news/news/drug-farm-presents-phase-1b-df-003-data-in-rosah-syndrome-at-arvo Fri, 08 May 2026 12:50:01 GMT https://eyewire.news/news/drug-farm-presents-phase-1b-df-003-data-in-rosah-syndrome-at-arvo Key Takeaways

  • Drug Farm reported early evidence that DF-003, a first-in-class oral ALPK1 inhibitor, improved visual function, optic nerve pathology, headaches, and systemic inflammatory symptoms in patients with ROSAH syndrome 
  • All six treated patients showed improvement in at least one clinical domain, with benefits reversing after treatment discontinuation, supporting a direct pharmacologic effect of ALPK1 inhibition
  • DF-003 was well tolerated with no serious adverse events during treatment, and Drug Farm plans to advance the therapy into a pivotal phase 3 trial

Drug Farm announced new ophthalmologic and central nervous system (CNS) findings from its Phase 1b clinical study of DF-003, a first-in-class oral ALPK1 inhibitor, at the Association for Research in Vision and Ophthalmology (ARVO) 2026 annual meeting in Denver, Colorado.

The presentation featured preliminary clinical outcomes from patients with ROSAH syndrome, a rare inherited autoinflammatory disease caused by activating mutations in the ALPK1 gene. The condition is characterized by progressive retinal degeneration, optic nerve pathology, and systemic inflammatory manifestations.

The poster, titled “ROSAH Syndrome – an ALPK1-related autoinflammatory disease: Preliminary CNS and ophthalmic clinical outcomes from the first six patients in a Phase 1b study treated with DF-003,” was presented during Poster Session 537: Retina/RPE: New drugs, mechanisms of action, metabolism, and toxicity on May 7, 2026, from 11:45 a.m. to 1:30 p.m.

The open-label Phase 1b study (NCT06395285) enrolled six adult patients with genetically confirmed ROSAH syndrome. Participants received once-daily oral DF-003 treatment for 28 days followed by a post-treatment observation period. According to the company, all six patients demonstrated improvement in at least one clinical domain during treatment. Notably, these improvements diminished after treatment discontinuation, providing evidence of a direct pharmacologic effect of DF-003.

Ophthalmologic evaluations showed encouraging signs of disease modulation in both the optic nerve and retina. Optical coherence tomography (OCT) assessments revealed reductions in optic disc swelling and peripapillary retinal thickness, with measurable changes observed as early as Day 29. One evaluable patient experienced clinically meaningful gains in visual function, including improvements in best-corrected visual acuity of +12 letters in the left eye and +5 letters in the right eye after only 8 days of treatment.

Beyond ocular outcomes, patients also demonstrated improvements in neurological and systemic symptoms. Headache severity improved during treatment as measured by the validated HIT-6 questionnaire, while symptoms worsened after therapy cessation. Investigators additionally reported reversal of anhidrosis and improvements in arthralgia, findings consistent with systemic anti-inflammatory activity.

DF-003 was reported to be well tolerated throughout the 28-day dosing period. No serious adverse events or treatment-emergent adverse events were observed during active treatment. The company also reported no clinically significant abnormalities in liver, renal, hematologic, or coagulation parameters. Adverse events occurring after discontinuation were described as consistent with recurrence of underlying ROSAH syndrome symptoms.

DF-003 is designed as a potent and selective inhibitor of disease-causing ALPK1 mutants, including T237M. The therapy is capable of penetrating both the blood-retina and blood-brain barriers and suppresses phosphorylation of TIFA, a key mediator of innate immune signaling and NF-κB activation.

Drug Farm said the reversibility of clinical and biomarker responses following discontinuation provides strong mechanistic evidence that the observed therapeutic effects are driven by on-target inhibition of the ALPK1 pathway.

“These early findings provide encouraging evidence that targeting ALPK1 may address both systemic and ocular manifestations of ROSAH syndrome,” said John Grigg, Professor of Clinical and Experimental Ophthalmology at the Save Sight Institute, University of Sydney. “The observed improvements in optic nerve pathology, visual function, and overall symptom burden, together with a favorable safety profile, support further clinical development of DF-003.”

Based on the phase 1b findings, Drug Farm plans to advance DF-003 into a pivotal phase 3 clinical trial to further evaluate its efficacy and safety across both systemic and ophthalmologic manifestations of ROSAH syndrome.

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Opus Genetics Reports Vision Restoration Data Across Multiple Gene Therapy Programs https://eyewire.news/news/opus-genetics-reports-vision-restoration-data-across-multiple-gene-therapy-programs Fri, 08 May 2026 12:35:19 GMT https://eyewire.news/news/opus-genetics-reports-vision-restoration-data-across-multiple-gene-therapy-programs Key Takeaways

  • Opus Genetics reported strong early clinical evidence that its OPGx-LCA5 gene therapy may restore cone-mediated daytime vision in children with severe inherited retinal disease, with improvements seen in visual acuity, light response, and daily functional vision
  • Early data from the company’s OPGx-BEST1 program showed meaningful visual improvements and retinal structural gains in treated patients
  • Preclinical findings from Opus Genetics’ RHO programs demonstrated preservation of retinal structure and function across animal models

Opus Genetics unveiled new clinical and preclinical findings at the Association for Research in Vision and Ophthalmology (ARVO) annual meeting, highlighting advances in therapies aimed at restoring vision and preventing blindness.

The company presented data from several programs, including OPGx-LCA5, OPGx-BEST1, and OPGx-RHO, providing evidence that gene therapy may be capable of restoring functional vision in patients with severe, early-onset retinal degeneration.

Pediatric LCA5 Study Shows Robust Vision Recovery

The centerpiece of the presentation was 6-month data from Opus Genetics’ ongoing phase 1/2/3 clinical trial evaluating OPGx-LCA5 in pediatric patients with Leber congenital amaurosis type 5 (LCA5).

Presented by principal investigator Tomas S. Aleman, MD, the findings demonstrated that children receiving a single subretinal injection of OPGx-LCA5 experienced substantial improvements in cone-mediated daytime vision despite having advanced disease at baseline.

According to the company, treated patients achieved more than 30-fold improvements in cone sensitivity, along with measurable gains in visual acuity compared to untreated control eyes. Researchers also reported improvements in pupillary light responses, orientation and mobility testing, and patient-reported daily visual function.

The therapy was reported to be well tolerated, with no dose-limiting toxicities and only mild, expected adverse events that resolved without complication.

“These results indicate that even in severe, early-onset disease, there remains a possible window of opportunity to restore cone function and meaningfully improve vision,” Dr. Aleman said during the presentation.

BEST1 Program Demonstrates Early Clinical Progress

Opus Genetics also shared preliminary results from an adult participant enrolled in its phase 1b/2a study of OPGx-BEST1, a gene therapy targeting retinal diseases caused by BEST1 mutations, including autosomal recessive bestrophinopathy (ARB) and Best vitelliform macular dystrophy (BVMD).

At 3 months post-treatment, the patient experienced up to a 12-letter improvement in visual acuity, alongside a roughly 23% reduction in central retinal thickness—a sign of improved retinal structure. No ocular inflammation or treatment-related adverse events were observed.

The company noted that Cohort 1 enrollment in the ongoing study has been completed, with topline 3-month data expected in September 2026.

In parallel, Opus presented new laboratory assay systems designed to validate gene expression and protein activity for OPGx-BEST1 manufacturing, a step aimed at supporting scalable production and regulatory readiness.

RHO Program Advances Toward Clinical Translation

Additional preclinical presentations focused on Opus Genetics’ mutation-independent approach to treating autosomal-dominant retinitis pigmentosa (RHO-adRP), a genetically diverse retinal disease.

In canine studies evaluating GMP-grade OPGx-RHO delivered via subretinal injection, researchers demonstrated preservation of retinal structure and function while establishing a no-observed-adverse-effect level (NOAEL) to guide future clinical dosing.

Separate swine-model studies evaluating a knockdown-and-replacement strategy showed restoration of rod-driven visual responses, maintenance of cone function, and preservation of photoreceptor structure over time. Researchers also identified a minimal effective dose and observed evidence suggesting interocular vector transfer, which may provide insight into systemic distribution dynamics.

The company stated that presentation materials and posters from ARVO 2026 will be made available through the Opus Genetics website.

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