Eyewire+ - Latest News https://eyewire.news The latest news stories from Eyewire+. en-us Mon, 09 Nov 2026 17:54:22 GMT Mon, 09 Nov 2026 17:54:22 GMT Core4 Viridian Therapeutics Reports Positive Phase 1 Results for VRDN-008, Plans Registrational Trial in 2027 https://eyewire.news/news/viridian-therapeutics-reports-positive-phase-1-results-for-vrdn-008-plans-registrational-trial-in-2027 Mon, 09 Nov 2026 14:15:24 GMT https://eyewire.news/news/viridian-therapeutics-reports-positive-phase-1-results-for-vrdn-008-plans-registrational-trial-in-2027 Key Takeaways

  • VRDN-008 achieved a 74% peak IgG reduction and sustained suppression through 8 weeks after dosing in healthy volunteers

  • The investigational FcRn inhibitor demonstrated a 15- to 18-day half-life and was generally well tolerated, with no serious adverse events

  • Viridian plans to initiate a registrational trial in myasthenia gravis in mid-2027, evaluating dosing every 4 or 8 weeks

Viridian Therapeutics announced positive phase 1 results for VRDN-008, an investigational, half-life-extended FcRn inhibitor, demonstrating sustained immunoglobulin G (IgG) reductions and a pharmacokinetic profile that could support subcutaneous dosing every 8 weeks.

The phase 1 trial evaluated VRDN-008 in healthy volunteers who received 2 subcutaneous doses, administered at baseline and week 4. Results showed a 74% peak reduction in IgG levels, with sustained suppression through 8 weeks after dosing.

VRDN-008 demonstrated an extended half-life of 15 to 18 days, approximately 6 times longer than first-generation Fc fragments, according to the company.

The treatment was generally well tolerated, with no serious adverse events or dose-limiting toxicities reported. Viridian also reported that VRDN-008 did not adversely affect albumin or low-density lipoprotein (LDL) levels.

VRDN-008 is a bifunctional FcRn inhibitor licensed from Paragon Therapeutics. It combines an Fc fragment with an albumin-binding domain designed to extend drug half-life and prolong IgG suppression.

Viridian plans to advance VRDN-008 into registrational development beginning with myasthenia gravis (MG) in mid-2027, pending regulatory feedback. The proposed multi-arm trial will evaluate subcutaneous VRDN-008 administered every 4 weeks or every 8 weeks compared with placebo.

The company intends to administer VRDN-008 using Enable Injections' EnFuse, a hands-free, wearable injector designed to support at-home self-administration.

Although Viridian has established a development focus in thyroid eye disease, the company plans to expand its pipeline into additional autoantibody-mediated autoimmune diseases through VRDN-008.

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Tenpoint Therapeutics Launches Telehealth Prescribing Program for Yuvezzi https://eyewire.news/news/tenpoint-therapeutics-launches-telehealth-prescribing-program-for-yuvezzi Mon, 09 Nov 2026 14:08:00 GMT https://eyewire.news/news/tenpoint-therapeutics-launches-telehealth-prescribing-program-for-yuvezzi Tenpoint Therapeutics has launched a telehealth prescribing program for Yuvezzi (carbachol and brimonidine tartrate ophthalmic solution) 2.75%/0.1%, providing adults with presbyopia an online option to determine their eligibility for a prescription treatment for presbyopia.

The program connects eligible adults with an ophthalmologist or optometrist for a virtual evaluation to determine whether Yuvezzi is appropriate. Patients can access the service through orderYuvezzi.com or by calling 800-204-3511.

According to Tenpoint, the initiative is intended to complement rather than replace routine in-person eye care. Participants will be encouraged to establish and maintain relationships with local eye care professionals for comprehensive examinations and ongoing eye health management.

To support that effort, the company has also launched Yuvezzidoctor.com, an online resource designed to help patients locate eye care professionals in their communities.

“Many adults experiencing blurry close-up vision – especially those who don’t have an ophthalmologist or optometrist – may not realize that new prescription eye drops like Yuvezzi are an option to help reduce the constant need for reading glasses,” said Carol Kearney, chief commercial officer of Tenpoint Therapeutics.

Ms. Kearney added that the telehealth initiative is intended to expand access to treatment evaluations while reinforcing the importance of comprehensive eye care and supporting local practices.

Previously known as Brimochol PF, Yuvezzi was approved by the FDA in January 2026.

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Zeiss Launches YouTube and TikTok Video Series to Expand Consumer Eye Health Education https://eyewire.news/news/zeiss-launches-youtube-and-tiktok-video-series-to-expand-consumer-eye-health-education Mon, 09 Nov 2026 13:50:30 GMT https://eyewire.news/news/zeiss-launches-youtube-and-tiktok-video-series-to-expand-consumer-eye-health-education Key Takeaways

  • Zeiss has launched five educational video formats across YouTube and TikTok to improve consumer access to eye health information

  • The content covers common vision conditions, eye examinations, and the science behind optical technologies

  • The initiative seeks to increase consumer understanding of visual health and encourage engagement with eye care professionals

Zeiss has introduced five new video formats across YouTube and TikTok designed to make eye health information more accessible and engaging for consumers.

The initiative follows a Zeiss survey finding that 85% of consumers expect lens brands to provide guidance in addition to selling products. The videos address common questions about vision and eye health, including preparing for eye examinations and understanding conditions such as myopia, astigmatism, and cataracts.

“Those are real questions people search for online, and we realized that Zeiss has the expertise to answer many of these questions,” said Claudia Rutten, Head of Brand Marketing at Zeiss Vision Care.

The company has developed two YouTube formats and three TikTok formats to accommodate different viewing preferences.

On YouTube, "Clearly Explained" features Zeiss experts discussing common eye conditions and broader vision health topics. "Science Behind" explores the research and innovation underlying Zeiss technologies through interviews with company experts, university partners, and other specialists.

The TikTok formats emphasize shorter, more conversational content. "Vision Answered" addresses questions submitted by viewers, while "Vision Revision" uses humorous classroom-style presentations to explain eye health concepts. "Make it Zeiss" draws on topics such as fashion, beauty, and sports to make complex vision concepts more relatable.

“Better visual health begins with better understanding,” said Steve Schallhorn, MD, Chief Medical Officer at Zeiss Medical Technology. “By making trusted, clinical-based knowledge more accessible to people through a variety of video formats, we can help empower them to take a more active role in protecting their own vision throughout life.”

According to Zeiss, the initiative aims to strengthen consumer understanding of visual health while encouraging greater engagement with eye care.

The first episodes are available on the Zeiss Vision YouTube channel and Zeiss Vision TikTok channel, with additional videos scheduled for release in the coming weeks.

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Ianalumab Reduces Disease Activity in Sjögren’s Disease in Two Phase 3 Trials https://eyewire.news/news/ianalumab-reduces-disease-activity-in-sjogrens-disease-in-two-phase-3-trials Mon, 09 Nov 2026 13:45:16 GMT https://eyewire.news/news/ianalumab-reduces-disease-activity-in-sjogrens-disease-in-two-phase-3-trials Key Takeaways

  • Monthly ianalumab significantly reduced systemic disease activity at week 48 in two phase 3 trials involving 779 patients with Sjögren’s disease

  • Neither trial demonstrated significant improvements in key patient-reported symptom measures or ESSDAI response rates

  • The findings support further evaluation of B-cell–targeted treatment

Monthly treatment with ianalumab (Novartis) significantly reduced systemic disease activity compared with placebo in two phase 3 clinical trials involving patients with active Sjögren’s disease, although the treatment did not demonstrate significant improvements in patient-reported symptoms.1

The findings, published in the New England Journal of Medicine, suggest that B-cell–targeted therapy may offer a potential disease-modifying approach for Sjögren’s disease, a systemic autoimmune condition associated with ocular dryness and salivary gland dysfunction.

The NEPTUNUS-1 and NEPTUNUS-2 trials, led by Xavier Mariette, MD, PhD, of Université Paris-Saclay and Hôpital Bicêtre in France, evaluated ianalumab, an investigational monoclonal antibody that depletes B cells and blocks the B-cell activating factor receptor.

The randomized, double-blind, placebo-controlled studies enrolled 779 patients with active Sjögren’s disease. NEPTUNUS-1 included 275 patients assigned to monthly subcutaneous ianalumab 300 mg or placebo. NEPTUNUS-2 included 504 patients assigned to ianalumab administered monthly, every 3 months, or placebo.

At week 48, monthly ianalumab achieved statistically significant reductions in the European Alliance of Associations for Rheumatology Sjögren’s Syndrome Disease Activity Index (ESSDAI), the primary endpoint in both trials.

Compared with placebo, the between-group difference in ESSDAI scores was −1.3 points in NEPTUNUS-1 (P=.0496) and −1.0 points in NEPTUNUS-2 (P=.04).

However, neither trial demonstrated a significant improvement in the proportion of patients achieving an ESSDAI response, defined as a reduction of at least 5 points. Significant improvements were also not observed in patient-reported symptom measures, including the Sjögren’s Syndrome Symptom Diary and EULAR Sjögren’s Syndrome Patient Reported Index.

Serious adverse events occurred at similar rates across treatment and placebo groups. Nonserious injection-site and systemic injection-related reactions were more common among patients receiving ianalumab.

The trials were funded by Novartis.

Reference

1. Mariette X, et al. Ianalumab for the Treatment of Patients with Sjögren’s Disease. N Engl J Med. 2026;395(16):1585-1599. doi:10.1056/NEJMoa2601088

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Study Links Colder Temperatures to Higher IOP in Patients with Glaucoma https://eyewire.news/news/study-links-colder-temperatures-to-higher-iop-in-patients-with-glaucoma Fri, 06 Nov 2026 18:13:21 GMT https://eyewire.news/news/study-links-colder-temperatures-to-higher-iop-in-patients-with-glaucoma Key Takeaways

  • Lower ambient temperatures were significantly associated with higher IOP in patients with medically controlled POAG

  • The temperature-IOP association appeared stronger in patients with severe glaucoma or those using multiple medications

  • Environmental temperature may be relevant to IOP monitoring, although further research is needed to establish clinical implications

A retrospective study published in the British Journal of Ophthalmology found that lower ambient temperatures were significantly associated with higher intraocular pressure (IOP) in patients with medically controlled primary open-angle glaucoma (POAG), suggesting that environmental temperature may contribute to IOP fluctuations.1

The study, led by Toru Ikushima, MD, of Kyoto Prefectural University of Medicine in Japan, analyzed 2,655 IOP measurements from 154 eyes of 77 patients treated between 2012 and 2023. Participants had a mean age of 65.8 years and were followed for an average of 5.2 years.

Eligible patients were at least 40 years old, had no history of ophthalmic surgery or changes in glaucoma medications, and attended at least three visits annually for 3 or more years. IOP was measured using Goldmann applanation tonometry.

Researchers used a linear mixed-effects model to assess associations between IOP and environmental factors, including ambient temperature, atmospheric pressure, humidity, wind speed and seasonal conditions. The analysis also accounted for clinical variables such as blood pressure, central corneal thickness, glaucoma severity and medication use.

Ambient temperature was negatively associated with IOP (estimate = −0.029; P = .003), while mean blood pressure showed a positive association (estimate = 0.021; P < .001).

The number of glaucoma medications, glaucoma type and time of day also significantly influenced IOP fluctuations. Additional analyses suggested that the association with temperature was more pronounced among patients with severe glaucoma or those using multiple glaucoma medications.

The investigators noted that the observational design prevents conclusions about causality. Potential confounders, including physical activity and obesity, were not assessed, and patients with poorly controlled IOP were excluded. The findings suggest that ambient temperature may warrant consideration when interpreting IOP measurements and managing patients with stable POAG. Larger studies are needed to determine whether the association extends to patients with milder disease or less intensive medical treatment.

Reference:

1. Ikushima T, et al. Effects of ambient temperature on intraocular pressure in patients with stable primary open-angle glaucoma under medical treatment. British Journal of Ophthalmology. Published online September 29, 2026. 

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SpaMedica Report Raises Concerns Over Mandatory Cataract Surgery Waiting Times in England https://eyewire.news/news/spamedica-report-raises-concerns-over-mandatory-cataract-surgery-waiting-times-in-england Fri, 06 Nov 2026 18:05:52 GMT https://eyewire.news/news/spamedica-report-raises-concerns-over-mandatory-cataract-surgery-waiting-times-in-england Key Takeaways

  • Mandatory cataract surgery waiting times of up to 16 weeks have been introduced by approximately half of England’s ICBs

  • Survey findings associate delayed surgery with reduced independence, worsening mental health, caregiver burden and increased healthcare utilization

  • SpaMedica recommends pausing further implementation of mandatory minimum waits pending comprehensive impact assessments

New research commissioned by SpaMedica suggests that mandatory minimum waiting times for cataract surgery in England may negatively affect patients’ independence, mental health and employment while increasing demands on families and the National Health Service (NHS).

Approximately half of England’s Integrated Care Boards (ICBs) have introduced mandatory minimum waiting times of up to 16 weeks for cataract surgery, compared with previous waits of approximately 4 weeks.

Source: SpaMedica

The report, Minimum Waiting Times for Cataract Surgery: The Impact on Patients, Families and the NHS, was developed with input from Age UK, RNIB, Fight for Sight and Thomas Pocklington Trust. It incorporates patient and caregiver surveys, interviews and economic analysis.

Among surveyed patients, 92% reported changing their driving habits while awaiting surgery, including 29% who stopped driving entirely. Among working-age respondents, 31% reduced their working hours and 21% stopped working. Additionally, 69% reported worsening mental health.

The findings also highlight the burden on caregivers. Approximately three-quarters of patients reported needing additional assistance after referral. In a separate survey of 300 family members and caregivers, 86% reported providing additional care because of declining patient health or independence, while 60% experienced increased stress or anxiety.

Delayed surgery may also increase healthcare utilization. Among surveyed patients, 19% reported attending an emergency department or receiving treatment following a trip or fall, while 33% required additional general practitioner appointments.

“Making patients wait longer when capacity is available risks being a false economy, with the consequences felt by patients, their families and the NHS,” said Richard Woodward, CEO of SpaMedica.

The report recommends that ICBs pause the introduction or expansion of mandatory minimum waiting times until their clinical, economic and equality impacts have been assessed. It also calls for greater involvement of patients, advocacy organizations and clinical leaders in waiting-time policy decisions.

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Founders Optical Unveils Refreshed Brand Following Acquisition by Newton https://eyewire.news/news/founders-optical-unveils-refreshed-brand-following-acquisition-by-newton Fri, 06 Nov 2026 17:33:01 GMT https://eyewire.news/news/founders-optical-unveils-refreshed-brand-following-acquisition-by-newton Founders Optical has unveiled a refreshed brand identity following its acquisition by Newton in November 2025.

According to Founders, the updated branding reflects investments in laboratory operations, staffing and customer service while maintaining the company's focus on independent eye care practices.

Since joining Newton, Founders Optical has focused on expanding its laboratory capabilities, adding specialized personnel, and improving operational performance. The company reported an average remake rate below 0.5%, with more than 80% of customers rating their likelihood of recommending the laboratory at 7 or higher on a 10-point scale.

Founders Optical has also expanded customer service coverage across Eastern, Central and Western regions, with support available from 8 a.m. to 7 p.m. CT. Its laboratory team has more than 60 years of combined experience, according to a company news release. 

The rebranding coincides with Newton's introduction of Newton Preferred, a program combining Neurolens technology, frames, patient financing and pricing options for independent practices. Through the program, participating practices can access enhanced rebate opportunities through Newton's Portfolio Advantage plans and laboratory services supporting Neurolens and Sequel lens technologies. Founders Optical will continue offering Unity lens designs, TechShield coatings, and other products.

Existing Founders Optical customers will retain their current accounts, service relationships and laboratory support teams.

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CMS Establishes Practice Expense Supply Code for TearCare SmartLids https://eyewire.news/news/cms-establishes-practice-expense-supply-code-for-tearcare-smartlids Fri, 06 Nov 2026 14:23:05 GMT https://eyewire.news/news/cms-establishes-practice-expense-supply-code-for-tearcare-smartlids Key Takeaways

  • CMS assigned a $1,000 supply valuation to TearCare SmartLids under new code SD397, effective January 1, 2027

  • The disposable component is used in thermal adaptive gland procedures for MGD reported under CPT code 0563T

The Centers for Medicare & Medicaid Services (CMS) has established a new direct practice expense supply code for the single-use TearCare SmartLids component of Sight Sciences’ TearCare System, assigning a value of $1,000 effective January 1, 2027.

The new code, SD397, was included in the calendar year 2027 Medicare Physician Fee Schedule Final Rule. The designation provides a nationally recognized valuation for the disposable component used in TearCare procedures to treat meibomian gland dysfunction (MGD).

CMS maintains a database of direct practice expense items and associated values to document the resources and costs involved in procedures reported under Current Procedural Terminology (CPT) codes.

“Establishing a validated, nationally recognized supply valuation for TearCare provides greater transparency into an important direct practice expense associated with the procedure,” said Paul Badawi, co-founder and CEO of Sight Sciences. “We appreciate CMS’ decision which we believe can support more transparent and consistent reimbursement for TearCare procedures over time.”

TearCare SmartLids adhere to the tarsal plates of the upper and lower eyelids and deliver software-controlled therapeutic heat to soften meibomian gland obstructions while allowing patients to blink during treatment.

The devices are used in the thermal adaptive gland procedure described by CPT code 0563T, which involves bilateral evacuation of the meibomian glands using heat delivered through wearable, open-eye eyelid devices, followed by manual gland expression.

The new supply code does not establish a national Medicare payment rate or separate reimbursement for SmartLids. CPT code 0563T remains carrier-priced, with payment decisions subject to individual payer coverage and reimbursement policies.

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VeonGen Therapeutics Secures FDA Alignment on Phase 3 Development of VG801 for Stargardt Disease https://eyewire.news/news/veongen-therapeutics-secures-fda-alignment-on-phase-3-development-of-vg801-for-stargardt-disease Fri, 06 Nov 2026 13:59:48 GMT https://eyewire.news/news/veongen-therapeutics-secures-fda-alignment-on-phase-3-development-of-vg801-for-stargardt-disease Key Takeaways

  • VeonGen reached FDA alignment on pivotal phase 3 trial design and manufacturing considerations for VG801

  • In phase 1/2 testing, 11 of 13 evaluable patients achieved BCVA gains of at least 5 ETDRS letters at Month 6 or Month 12

  • VG801 uses a dual-AAV platform designed to deliver a functional ABCA4 gene, potentially addressing multiple Stargardt disease genotypes

VeonGen Therapeutics announced regulatory progress for VG801, its investigational dual-adeno-associated virus (AAV) gene therapy for Stargardt disease and other ABCA4-associated retinal dystrophies, including FDA alignment on key aspects of its planned pivotal phase 3 trial.

During a Regenerative Medicine Advanced Therapy (RMAT) Type B meeting, the FDA and VeonGen reached alignment on the phase 3 study design, including the primary endpoint, study duration, and control arm. The agency also agreed on key chemistry, manufacturing, and controls considerations, including use of the existing clinical batch for the pivotal study and elements of the commercial manufacturing strategy.

The company is also advancing its Virtual Reality Visual Test (VRVT) through the FDA's Rare Disease Endpoint Advancement Pilot Program as a potential functional vision endpoint. Phase 1/2 clinical trial authorizations have been obtained in Europe and China.

The ongoing first-in-human phase 1/2 study (NCT07002398) has enrolled and dosed 15 adult and pediatric patients across 3 dose cohorts.

According to company-reported findings, all 13 patients with measurable baseline best-corrected visual acuity (BCVA) demonstrated improvement at Month 6 or Month 12. Eleven patients gained at least 5 Early Treatment Diabetic Retinopathy Study (ETDRS) letters, including 7 who gained at least 10 letters, and 4 who gained at least 15 letters.

VeonGen also reported sustained improvements through Month 12 across VRVT and microperimetry fixation assessments, with stable retinal structures and a favorable safety profile to date.

“FDA alignment on the pivotal phase 3 clinical and CMC strategy represents an important de-risking milestone for VG801 and a significant step toward global pivotal development,” said Caroline Man Xu, MD, cofounder and chief executive officer of VeonGen Therapeutics.

VG801 combines the company's vgAAV2 capsid technology with its vgRNA REVeRT platform to deliver and reconstitute a full-length functional human ABCA4 gene in retinal photoreceptor cells. The dual-AAV approach is designed to address Stargardt disease across different ABCA4 mutations.

VG801 has received FDA RMAT, Rare Pediatric Disease, and Orphan Drug designations. 

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Studies Link Cataract Surgery to Improved Quality of Life and Economic Security in Rural Mozambique https://eyewire.news/news/studies-link-cataract-surgery-to-improved-quality-of-life-and-economic-security-in-rural-mozambique Fri, 06 Nov 2026 13:53:18 GMT https://eyewire.news/news/studies-link-cataract-surgery-to-improved-quality-of-life-and-economic-security-in-rural-mozambique Key Takeaways

  • Studies conducted in rural Mozambique suggest cataract surgery is associated with greater work participation, and improved food and income security

  • Median quality-of-life scores increased from 38.5 to 81 at 12 months following cataract surgery

Two studies conducted in rural Mozambique suggest cataract surgery is associated with improvements extending beyond vision restoration, including greater work participation, improved food and income security, reduced stigma, and better quality of life.

The research, supported by international development organization Sightsavers, highlights the potential social and economic benefits of expanding access to cataract surgery in underserved communities.

The quantitative study, published in The Lancet Regional Health – Africa, collected data from more than 800 adults before cataract surgery and at 12-month follow-up. Median quality-of-life scores increased from 38.5 before surgery to 81 after surgery.

Researchers also reported several improvements in participants' daily functioning and economic circumstances:

  • Severe functional difficulties in nonvision domains, including self-care, decreased by 44.2 percentage points

  • Participation in personal work activities, including farming, increased by 40.7 percentage points

  • Reported food and income insufficiency decreased by 42.3 and 25.8 percentage points, respectively

  • Internalized stigma and community stigma decreased by 51 and 34.7 percentage points, respectively

A companion qualitative study, published in SSM – Qualitative Research in Health, examined participants' experiences following surgery, documenting improvements in independence, confidence, and engagement in daily activities.

Stevens Bechange, PhD, global technical lead for health and disability research at Sightsavers and lead author of both studies, emphasized the broader implications for health policy.

“Eye care is often a ‘missing’ topic from health and development priorities. But our studies show that cataract surgery is associated with improved daily functioning, renewed confidence and greater economic participation, as well as better vision,” Dr. Bechange said.

The findings reinforce calls for increased investment in accessible eye care, particularly in regions where cataracts remain a major contributor to avoidable vision impairment.

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Link Biologics Completes IND-Enabling Preclinical Program for Dry Eye Disease Therapy LB001 https://eyewire.news/news/link-biologics-completes-ind-enabling-preclinical-program-for-dry-eye-disease-therapy-lb001 Thu, 05 Nov 2026 14:32:45 GMT https://eyewire.news/news/link-biologics-completes-ind-enabling-preclinical-program-for-dry-eye-disease-therapy-lb001 Key Takeaways

  • Link Biologics completed IND-enabling preclinical studies for LB001, an investigational TSG-6-based eye drop for moderate to severe DED

  • Repeat-dose ocular toxicology studies demonstrated favorable tolerability, a wide safety margin, and minimal systemic exposure

  • An IND submission is planned for Q1 2027, followed by a phase 1/2 clinical trial pending regulatory clearance

Link Biologics has completed its investigational new drug (IND)-enabling preclinical program for LB001 (Link_TSG6), a first-in-class TSG-6-based eye drop being developed for moderate to severe dry eye disease (DED).

The milestone supports the company's planned IND submission in the first quarter of 2027, with a phase 1/2 clinical trial expected to follow pending regulatory clearance.

LB001 is designed to address both inflammation and ocular surface damage associated with DED through a dual anti-inflammatory and tissue-reparative mechanism of action. The investigational therapy is intended to provide an alternative to existing treatments by targeting multiple underlying components of the disease.

The preclinical program included repeat-dose ocular toxicology studies lasting up to 13 weeks. According to the company, the studies demonstrated favorable tolerability, a wide safety margin, and minimal systemic exposure.

Link Biologics also reported progress in manufacturing readiness, completing 2 good manufacturing practice (GMP) production runs to supply the planned phase 1/2 clinical study.

"The completion of our IND-enabling program, supported by favorable safety and tolerability findings and successful GMP manufacturing scale-up, significantly derisks LB001 as we prepare for IND submission," said Reuben Dawkins, chief executive officer and co-founder of Link Biologics.

Mr. Dawkins added that the therapy's ability to target both inflammation and ocular surface damage could address limitations of existing DED treatments.

With preclinical development completed, the company is preparing its IND submission for the first quarter of 2027. If cleared, Link plans to initiate a phase 1/2 study evaluating LB001 in patients with DED.

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Prism Vision Group Acquires Spectrum Vision Partners, Expanding Ophthalmology Network Across Five States https://eyewire.news/news/prism-vision-group-acquires-spectrum-vision-partners-expanding-ophthalmology-network-across-five-states Thu, 05 Nov 2026 14:26:08 GMT https://eyewire.news/news/prism-vision-group-acquires-spectrum-vision-partners-expanding-ophthalmology-network-across-five-states Key Takeaways

  • Prism Vision Group has acquired Spectrum Vision Partners, which supports more than 150 independent eye care providers

  • The transaction adds 58 ophthalmology sites and 5 ambulatory surgery centers across five states to Prism's network

  • The affiliation aims to preserve physician-led governance while expanding retina services, research opportunities, and access to clinical trials

Prism Vision Group has acquired Spectrum Vision Partners, a practice administrative services organization supporting more than 150 independent eye care providers across the Mid-Atlantic and New England regions.

Financial terms of the acquisition were not disclosed.

The acquisition expands Prism’s network of ophthalmology and retina practices. Headquartered on Long Island, New York, Spectrum supports 58 ophthalmology sites of care and 5 ambulatory surgery centers across New York, Pennsylvania, Connecticut, New Jersey, and West Virginia.

“The physicians supported by Spectrum Vision Partners are nationally recognized, deeply engaged in advancing the field of ophthalmology, and committed to delivering exceptional care to patients,” said Steven Madreperla, MD, PhD, chief executive officer of Prism Vision Group.

Eric Donnenfeld, MD, and Richard Sturm, MD, managing partners of Spectrum Vision Partners, said the affiliation reflects shared priorities involving clinical quality, physician leadership, and long-term sustainability.

Under the agreement, Spectrum-supported practices will retain physician-led governance while gaining access to Prism’s operational infrastructure, research capabilities, and care coordination resources. The acquisition is also expected to create opportunities to expand retina services, improve ambulatory surgery center utilization, and increase patient access to therapies and clinical trials.

Prism provides administrative and business support to ophthalmology and retina practices, with access to infrastructure and resources through McKesson Corporation.

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AEYE Health Wins 2026 Prix Galien USA Award for Autonomous AI Diabetic Retinopathy Screening Technology https://eyewire.news/news/aeye-health-wins-2026-prix-galien-usa-award-for-autonomous-ai-diabetic-retinopathy-screening-technology Wed, 04 Nov 2026 14:38:32 GMT https://eyewire.news/news/aeye-health-wins-2026-prix-galien-usa-award-for-autonomous-ai-diabetic-retinopathy-screening-technology Key Takeaways

  • AEYE-DS received the 2026 Prix Galien USA Award for Best Digital Health Solution

  • Clinical trials involving more than 1,200 patients demonstrated 92%-93% sensitivity, 89%-94% specificity, and greater than 99% imageability

  • The FDA-cleared technology enables autonomous diabetic retinopathy screening in primary care settings without physician interpretation

AEYE Health has received the 2026 Prix Galien USA Award for "Best Digital Health Solution" for AEYE-DS, its FDA-cleared autonomous artificial intelligence (AI) technology designed to detect diabetic retinopathy at the point of care without physician interpretation.

The company was selected from 25 nominees in the Best Digital Health category. The award recognizes the work of Zack Dvey-Aharon, PhD, co-founder and CEO of AEYE Health and inventor of AEYE-DS, and the company's development team.

AEYE-DS enables diabetic eye screening during routine primary care visits and in other healthcare settings. The technology uses a single retinal image per eye without dilation and provides diagnostic results in less than 1 minute. It is compatible with portable and tabletop imaging systems, allowing nurses and medical assistants to perform examinations without requiring a specialist to interpret the images.

According to the company, AEYE-DS was evaluated in 3 prospective, controlled, multicenter phase 3 pivotal clinical trials involving more than 1,200 patients. The studies demonstrated sensitivity of 92% to 93%, specificity of 89% to 94%, and imageability exceeding 99%.

The technology has been deployed across dozens of US healthcare systems and hospitals. Its integration with electronic health record systems is designed to streamline documentation, referrals, and reimbursement while expanding access to diabetic retinopathy screening.

"Receiving the Prix Galien Award is one of the greatest honors of my professional life and an extraordinary recognition of the work of the AEYE Health team," Dr. Dvey-Aharon said.

AEYE Health is also developing AEYE-X, an investigational AI-based oculomics platform designed to assess more than 100 health indications using retinal images. The platform targets cardiovascular, metabolic, neurological, and ocular conditions, potentially extending retinal imaging applications beyond traditional eye care.

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Newton Launches Newton Preferred Membership Program for Independent Eye Care Practices https://eyewire.news/news/newton-launches-newton-preferred-membership-program-for-independent-eye-care-practices Wed, 04 Nov 2026 14:24:06 GMT https://eyewire.news/news/newton-launches-newton-preferred-membership-program-for-independent-eye-care-practices Key Takeaways

  • Newton Preferred combines Neurolens technology, exclusive frames, patient financing, and practice incentives in one membership program

  • Benefits include 0% N3 headset financing, quarterly Neurolens rebates, and preferred pricing on Sequel lenses

  • Program benefits begin December 1, 2026, with early access enrollment closing December 31, 2026

Newton has announced the launch of Newton Preferred, a membership program designed to help independent optometry practices differentiate their services through integrated lens technology, eyewear, financing, and pricing benefits.

The program combines Newton's Neurolens technology with practice-focused financial incentives and patient purchasing options as independent optometrists face increasing competition from corporate chains and private equity-backed eye care groups.

According to Newton, at the center of Newton Preferred is the Neurolens platform, which addresses ocular misalignment. Participating practices receive access to 0% financing for the N3 headset and the company's full software platform.

The membership also includes Newton&co., an exclusive frame collection curated by Newton and supplied by Founders Optical. The frames are included with every patient prescription under the program, with the goal of encouraging patients to purchase eyewear directly from their independent eye care provider.

Additional benefits include Newton Pay, a patient financing option offered through Cherry that allows patients to make monthly payments for vision care services and products.

Newton Preferred also offers quarterly volume-based Neurolens rebates and preferred pricing on Sequel lenses, which are designed for patients experiencing digital eye strain. According to the company, these incentives are intended to help practices offset technology investments and expand their lens offerings.

Presale enrollment is currently open. Program benefits begin December 1, 2026, for practices joining through the purchase of the N3 platform. Early access enrollment closes December 31, 2026. Existing Neurolens providers can enroll beginning December 1. Additional information is available at www.newton.tech/preferred.

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Zeiss Commits to Expanding Global Eye Care Access at IAPB Summit https://eyewire.news/news/zeiss-commits-to-expanding-global-eye-care-access-at-iapb-summit Tue, 03 Nov 2026 20:50:13 GMT https://eyewire.news/news/zeiss-commits-to-expanding-global-eye-care-access-at-iapb-summit Key Takeaways

  • Zeiss plans to expand its Aloka Vision model to at least two additional countries by 2028, including support for post-cataract care

  • Two initiatives each aim to reach an additional 1 million people annually through eye care services, awareness, and improved access

  • The commitments build on existing partnerships supporting ophthalmic training, equipment donations, and eye care delivery in underserved regions

Zeiss has announced commitments to expand access to eye care, strengthen local ophthalmic services, and improve cataract-related care at the inaugural Global Summit for Eye Health, organized by the International Agency for the Prevention of Blindness (IAPB) and World Health Organization (WHO) on November 2, 2026, in Antigua and Barbuda.

As a High Impact Partner, Zeiss outlined plans to expand its Aloka Vision model to at least two additional countries by 2028 and support country-specific eye health programs. Each initiative aims to reach an additional 1 million people annually.

Operating in India since 2015, the Aloka Vision initiative provides vision screenings, refractions, customized eyewear, and assistance with ophthalmic treatment costs to underserved communities. Now operating independently as the nonprofit Aloka Vision Foundation, the organization has served more than 1.5 million patients.

The planned expansion will involve collaboration with governments and other partners to develop a replicable model that also supports patients following cataract surgery through follow-up screenings and refractive error correction.

“As one of the world’s leading ophthalmic technology companies, Zeiss is uniquely positioned to anchor our commitment focused on what remains the leading cause of blindness worldwide: cataracts,” said Steve Schallhorn, MD, chief medical officer of Zeiss Medical Technology.

Alongside the Aloka expansion, Zeiss plans to strengthen local eye care capacity through school and community programs, professional education, and donations of certified screening equipment, eyeglasses, and intraocular lenses.

Since 2005, Zeiss has supported eye care centers in Tanzania, Nigeria, Indonesia, and Latin America. Its initiatives have also included phacoemulsification training centers and equipment donations to the Orbis Flying Eye Hospital and hospitals in Mozambique, the Philippines, and Cambodia.

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Moorfields Eye Hospital Appoints Aruna Mehta as New Chair https://eyewire.news/news/moorfields-eye-hospital-appoints-aruna-mehta-as-new-chair Tue, 03 Nov 2026 18:56:54 GMT https://eyewire.news/news/moorfields-eye-hospital-appoints-aruna-mehta-as-new-chair Key Takeaways

  • Aruna Mehta became chair of Moorfields Eye Hospital on November 1, 2026, succeeding interim chair Professor Tim Briggs

  • Ms/ Mehta brings extensive NHS governance experience and more than 20 years in international financial services

Moorfields Eye Hospital has appointed Aruna Mehta as its new chair, effective November 1, 2026. Ms. Mehta succeeds Professor Tim Briggs, who stepped down as interim chair at the end of October.

Ms. Mehta brings extensive experience in National Health Service (NHS) leadership, governance, and organizational transformation. She currently serves as chair of Surrey and Borders Partnership NHS Foundation Trust, a position she will retain alongside her new role at Moorfields. She previously held senior non-executive positions at Tavistock and Portman NHS Foundation Trust and Epsom and St Helier University Hospitals NHS Trust. Ms. Mehta also has more than 20 years of experience in international financial services, specializing in governance, operational risk, and large-scale organizational change.

“I am delighted to be joining Moorfields and its exceptional staff,” Ms. Mehta said. “Moorfields’ reputation for world leading eye care is built on the dedication and expertise of its people, and I am looking forward to supporting the organisation as it continues to innovate, strengthen partnerships and deliver outstanding care for patients.”

Ms. Mehta emphasized that her initial priorities will include engaging with staff, patients, and partners to better understand their needs and perspectives. She also expressed a commitment to fostering an inclusive and supportive workplace.

“Aruna brings deep experience in governance, transformation and system leadership, and her insight will be hugely valuable as we deliver our strategy. I am confident that Aruna will play a key role in supporting Moorfields’ continued leadership in eye care, research and education," said Peter Ridley, Moorfields’ chief executive.

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Harrow Launches HarrowRx Prescribing Platform to Streamline Ophthalmic Medication Access https://eyewire.news/news/harrow-launches-harrowrx-prescribing-platform-to-streamline-ophthalmic-medication-access Tue, 03 Nov 2026 15:12:35 GMT https://eyewire.news/news/harrow-launches-harrowrx-prescribing-platform-to-streamline-ophthalmic-medication-access Key Takeaways

  • HarrowRx consolidates prescribing for Harrow’s branded ophthalmic medications within existing EMR systems

  • The PhilRx-powered platform coordinates prescription fulfillment, benefits verification, prior authorizations, and eligible patient savings programs

  • Harrow plans to expand the platform’s features and services to further simplify medication access and practice workflows

Harrow announced the launch of HarrowRx, a prescribing and pharmacy access platform designed to simplify how eye care professionals prescribe the company’s ophthalmic medications and connect patients with fulfillment and affordability services.

Powered by pharmacy partner PhilRx, HarrowRx allows clinicians to prescribe Harrow’s entire branded portfolio through a single destination within their existing electronic medical record (EMR) systems. The platform coordinates prescription routing, fulfillment, and applicable patient-support programs without requiring separate prescribing software or additional logins.

HarrowRx is a licensed pharmacy registered on the Surescripts network and can be located in connected EMR pharmacy directories by searching its name, NCPDP ID (3694886), or NPI (1578473732).

The platform supports prescription-benefit medications through PhilRx pharmacy operations, while physician-administered, buy-and-bill products are directed to their respective distributors. Eligible patients may also receive assistance with benefits verification, insurance authorizations, and available savings programs.

According to Harrow, the platform addresses administrative challenges associated with navigating multiple specialty pharmacies, fulfillment channels, and manufacturer assistance programs.

“When I visit with customers, I consistently hear the same frustrations: figuring out which specialty pharmacy or hub handles each product, remembering to complete prior authorization forms, and making sure patients have access to every available manufacturer savings program,” said Mark L. Baum, Chief Executive Officer of Harrow. “We created HarrowRx to take that complexity off their plates and build upon the trust that our customers have in the Harrow brand."

Prescribers can begin using HarrowRx by selecting the pharmacy within a connected EMR. If HarrowRx does not appear in their EMR’s pharmacy finder, prescribers can also send prescriptions to HarrowRx by phone at 855-977-0975 or by fax at 888-975-0603. For questions and additional support, practices can contact clinical support at 855-977-0975 or their Harrow account representative.

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Z Optics Expands Z+ Virtual Aperture IOL Clinical Trial to Canada https://eyewire.news/news/z-optics-expands-z-virtual-aperture-iol-clinical-trial-to-canada Tue, 03 Nov 2026 15:04:44 GMT https://eyewire.news/news/z-optics-expands-z-virtual-aperture-iol-clinical-trial-to-canada Key Takeaways

  • Z Optics has received approval to expand its European Z+ Virtual Aperture IOL clinical trial into Canada

  • The investigational lens is designed to provide continuous near-to-distance vision while minimizing visual disturbances associated with multifocal IOLs

  • Canadian study sites will be announced as activated, with clinical results expected after data collection and analysis

Z Optics announced that its ongoing European clinical study evaluating the Z+ Virtual Aperture IOL has received approval to expand into Canada, allowing Canadian clinical sites to participate in the multicenter trial.

The expansion marks the first opportunity for Canadian patients to access the investigational lens through a clinical study.

The trial is evaluating the safety and performance of the Z+ Virtual Aperture IOL, which is designed to provide continuous vision across near, intermediate, and distance ranges under both daytime and nighttime lighting conditions.

Built on a monofocal platform, the lens uses a light-reshaping approach rather than splitting light, redirecting out-of-focus light away from the central retina. According to the company, the technology is intended to reduce halos, glare, and other visual disturbances associated with multifocal IOL designs.

Z Optics reported positive preliminary feedback from European investigators and patients since enrollment began. Investigators have described a broad depth of focus, favorable visual outcomes, and a surgical experience similar to standard monofocal IOL implantation. Quantitative clinical results have not yet been released.

“The response from patients and physicians in our European study has exceeded our expectations,” said Luke Clauson, CEO of Z Optics. “Extending the trial to Canada is an important step for the program. It broadens the clinical evidence base for the Virtual Aperture technology and, just as importantly, it means patients and surgeons in Canada can now experience this lens within the study.”

The company plans to announce participating Canadian clinical sites as they become activated. Clinical results are expected following completion of data collection and analysis, although a reporting timeline has not been specified.

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Hundred Vision Launches Luma Eye-Tracking System to Assess Oculomotor and Binocular Visual Function https://eyewire.news/news/hundred-vision-launches-luma-eye-tracking-system-to-assess-oculomotor-and-binocular-visual-function Mon, 02 Nov 2026 18:12:49 GMT https://eyewire.news/news/hundred-vision-launches-luma-eye-tracking-system-to-assess-oculomotor-and-binocular-visual-function Key Takeaways

  • Luma provides objective eye-tracking measurements of oculomotor, binocular, and reading-related visual function

  • The system includes 11 tests, age-adapted workflows, and reporting tools for clinical interpretation and longitudinal monitoring

Hundred Vision has introduced Luma, an eye-tracking and visual function assessment system designed to provide eye care professionals with objective measurements of oculomotor performance, binocular vision, and reading-related visual function.

Unveiled during a global livestream coinciding with World Sight Day, Luma is designed to complement conventional visual acuity testing by measuring how the eyes fixate, track moving targets, shift gaze, and coordinate during visual tasks. The system combines a Tobii eye-tracking sensor, interactive display, patient-response keypad, and assessment software. Red-green dichoptic glasses are incorporated into selected binocular vision tests.

Luma's initial version includes 11 tests across five domains: symptoms, foundational visual function, oculomotor function, binocular alignment and function, and reading assessment. Measurements include fixation stability, saccadic accuracy and latency, smooth pursuit performance, vergence responses, and reading speed.

Assessment workflows are tailored to five age groups, beginning at age 3. Clinicians can also customize test batteries according to individual assessment objectives.

According to Hundred Vision, development involved more than 19,000 hours of clinical work, development, and testing, informed by over 1,000 interactions with eye care professionals.

The system generates reports tailored to clinicians, patients or parents, and other health care professionals. Clinical reports include quantitative measurements, eye-movement visualizations, recording-quality information, and age-referenced comparisons where available.

Luma also supports longitudinal assessments, allowing clinicians to compare measurements across visits and monitor changes in visual performance.

The company emphasized that Luma does not establish diagnoses or recommend treatment. Findings must be interpreted alongside patient history, symptoms, and other clinical examination results.

Additional information is available at luma-tracker.com.

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Johnson & Johnson Announces Global Commitment to Expand Access to Eye Care and Prevent Vision Loss https://eyewire.news/news/johnson-johnson-announces-global-commitment-to-expand-access-to-eye-care-and-prevent-vision-loss Mon, 02 Nov 2026 14:57:33 GMT https://eyewire.news/news/johnson-johnson-announces-global-commitment-to-expand-access-to-eye-care-and-prevent-vision-loss Key Takeaways

  • Johnson & Johnson announced a global commitment to expand access to vision screening, cataract surgery, and essential ophthalmic care

  • Existing initiatives have reached nearly 60 million children through Sight For Kids and helped restore sight to more than 70,000 cataract patients

  • The company is supporting ophthalmic training, product donations, and affordable retinal imaging technology to improve eye care in underserved communities

Johnson & Johnson, with support from the Johnson & Johnson Foundation, announced a global commitment to expand access to eye care through partnerships, education, product donations, and advocacy aimed at reducing preventable vision loss.

The commitment was highlighted at the inaugural Global Summit for Eye Health, co-hosted by the Government of Antigua and Barbuda in technical collaboration with the World Health Organization (WHO), with support from the International Agency for the Prevention of Blindness (IAPB).

According to the company, more than 2 billion people worldwide experience poor vision, including more than 1 billion whose vision loss could have been prevented or treated. More than 90% of vision loss cases are preventable or treatable through interventions such as corrective eyeglasses and cataract surgery.

“Vision shapes how we learn, work and experience the world around us, yet too many people are living with vision impairment that could be prevented or treated with access to quality eye care,” said Jacqueline Henderson, company group chair, Vision, Johnson & Johnson.

The company's ongoing initiatives include Sight For Kids, a school-based eye health program established with Lions Clubs International Foundation in 2002. The program has reached nearly 60 million children through vision screenings, examinations, and access to eyeglasses.

Through partnerships with organizations including SEE International, Johnson & Johnson has also supported cataract surgery programs that have restored sight to more than 70,000 patients in underserved communities.

Additional efforts include donations of IOLs, ophthalmic equipment, and surgical training resources through organizations such as the Cure Blindness Project.

The J&J Foundation's Impact Ventures fund is also supporting Phelcom Technologies in developing affordable handheld retinal imaging systems to improve screening and diagnosis in resource-limited settings.

Johnson & Johnson said it will continue collaborating with IAPB to promote eye health as a global public health priority. These activities are part of the company's broader J&J CareCommunity social impact platform.

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Eyedaptic Launches AI-Powered Visual Assistant for EYE7 Smart Glasses https://eyewire.news/news/eyedaptic-launches-ai-powered-visual-assistant-for-eye7-smart-glasses Mon, 02 Nov 2026 14:49:48 GMT https://eyewire.news/news/eyedaptic-launches-ai-powered-visual-assistant-for-eye7-smart-glasses Key Takeaways

  • Eyedaptic launched Eva, an agentic AI assistant that integrates natural-language processing with vision enhancement in EYE7 smart glasses

  • Company testing demonstrated greater than 99% reading accuracy and 97% command accuracy, with support for up to 99 languages

Eyedaptic announced the launch of Eva (Eyedaptic Visual Assistant), an agentic AI assistant integrated into its EYE7 Vision Enhancing Smart Glasses platform to help individuals with age-related macular degeneration (AMD) and other visual impairments perform everyday activities.

Eva combines AI-based visual interpretation, natural-language processing, and direct control of the glasses' vision-enhancement features. Unlike conventional AI assistants that primarily provide information, Eva is designed to interpret user intent and automatically adjust visual settings in response to conversational requests.

For example, when a user says, "I can't read that," the system can interpret the request and modify the visual experience without requiring a specific command, according to Eyedaptic.

According to Eyedaptic, internal testing demonstrated greater than 99% reading accuracy and 97% command accuracy. The system also supports communication in up to 99 languages.

The technology is designed to assist with reading, shopping, identifying objects, watching television, navigating environments, and other daily activities.

“Eva is more than an assistant; it’s an intelligent partner,” said Jay Cormier, CEO & Founder of Eyedaptic. “By combining agentic AI with real-time control of vision enhancement, we are delivering a system that doesn’t just inform the user, but actively optimizes how they see to accomplish everyday tasks."

The company also cited findings from a recent independent clinical study in patients with advanced retinal disease, which demonstrated an average immediate improvement of 5.7 lines in near visual acuity using Eyedaptic technology. 

Eva is now available to EYE7 users and can be upgraded remotely through the existing smart glasses platform.

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FDA Approves Lucamzi as Ranibizumab Biosimilar https://eyewire.news/news/fda-approves-lucamzi-as-ranibizumab-biosimilar-to-lucentis-for-retinal-diseases Mon, 02 Nov 2026 14:15:57 GMT https://eyewire.news/news/fda-approves-lucamzi-as-ranibizumab-biosimilar-to-lucentis-for-retinal-diseases Key Takeaways

  • The FDA approved Lucamzi (ranibizumab-blrz) as a biosimilar to Lucentis, with a US launch planned for 2027

  • A phase 3 study involving 582 patients with wet AMD demonstrated equivalent efficacy and comparable safety to the reference product

The FDA has approved Lucamzi (ranibizumab-blrz), developed by Xbrane Biopharma, as a biosimilar to Lucentis (ranibizumab), providing another anti-VEGF treatment option for patients with wet age-related macular degeneration (AMD) and other retinal vascular diseases.

Xbrane and its commercial partners are finalizing preparations for a planned US launch in 2027.

Ranibizumab is an anti-vascular endothelial growth factor (VEGF) therapy used to treat retinal vascular disorders. The approval was supported by a comparative analytical assessment of the biosimilar's structural and functional characteristics, along with results from a phase 3 clinical trial involving 582 patients with wet AMD. The study demonstrated equivalent efficacy and comparable safety between Lucamzi and the reference product, according to Xbrane.

“FDA approval of Lucamzi is a landmark event for Xbrane, representing a key opportunity to reach many more patients and to realize a return on our development investments,” said Martin Åmark, CEO of Xbrane Biopharma.

The company highlighted the potential economic implications of expanded biosimilar competition in the retinal disease market. According to Xbrane, approximately 20 million people in the United States are living with AMD, and the annual economic burden of late-stage disease is estimated at $49.4 billion. Xbrane also estimated that anti-VEGF therapies for retinal disorders represent approximately €9 billion in annual global net sales, with roughly 10 million injections administered annually.

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OpZira Completes Stage II Audit for AdaptDx Pro, Advances Plans for European CE Marking https://eyewire.news/news/opzira-completes-stage-ii-audit-for-adaptdx-pro-advances-plans-for-european-ce-marking Mon, 02 Nov 2026 14:01:55 GMT https://eyewire.news/news/opzira-completes-stage-ii-audit-for-adaptdx-pro-advances-plans-for-european-ce-marking Key Takeaways

  • OpZira's subsidiary AdaptDx completed its Stage II audit, advancing ISO certification efforts and plans for European CE marking in 2027

  • AdaptDx Pro measures rod-mediated dark adaptation, a functional biomarker associated with early retinal dysfunction and dry AMD

  • Clinical research, including the ALLSTAR 2 studies, supports the potential role of RMDA testing in detecting and monitoring retinal disease

OpZira announced that its subsidiary, AdaptDx, has completed its Stage II audit at the company's Lighthouse medical device manufacturing facility, marking a step toward ISO certification and planned CE marking of AdaptDx Pro in the European Union in 2027.

AdaptDx Pro is a portable dark adaptometer designed to objectively measure rod-mediated dark adaptation (RMDA), a functional indicator of retinal health. The device is currently available in the United States as a Class I medical device.

RMDA testing assesses the eye's ability to adapt to low-light conditions, a function that may be impaired in patients with early retinal disease. Dark adaptation dysfunction can manifest as difficulty driving at night or reading in dim lighting.

According to OpZira, dark adaptation technology has been evaluated in more than 42 peer-reviewed publications. Recent findings from the prospective, 3-year ALLSTAR 2 studies have further demonstrated the potential value of RMDA as a biomarker in patients with early dry age-related macular degeneration (AMD).

“Completion of the Stage II audit marks an important step in our strategy to expand the global availability of AdaptDx Pro,” said Clark Tedford, PhD, President and CEO of OpZira. “Our AdaptDx Pro technology provides an objective, quantitative biomarker of retinal dysfunction and with the approval of early treatments, the importance of early detection and monitoring become critically important to guide the physicians.”

The company said its certification efforts are intended to support broader international access to AdaptDx Pro and its use in clinical decision-making and disease monitoring.

OpZira was established following Alcon's acquisition of LumiThera and its Valeda Light Delivery System, an FDA-authorized treatment for dry AMD.

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Okogen Doses First Patient in Phase 1/2 EMERALD Trial of Treyegen for Acute Infectious Conjunctivitis https://eyewire.news/news/okogen-doses-first-patient-in-phase-12-emerald-trial-of-treyegen-for-acute-infectious-conjunctivitis Mon, 02 Nov 2026 13:46:40 GMT https://eyewire.news/news/okogen-doses-first-patient-in-phase-12-emerald-trial-of-treyegen-for-acute-infectious-conjunctivitis Key Takeaways

  • Okogen has dosed the first patient in its Phase 1/2 EMERALD trial of Treyegen for acute infectious conjunctivitis

  • Treyegen combines ranpirnase, tobramycin, and oxymetazoline to target infectious causes and ocular congestion

  • The multicenter study will evaluate safety and potential clinical efficacy in a condition with overlapping viral and bacterial presentations

Okogen announced that the first patient has been dosed in its phase 1/2 EMERALD trial evaluating Treyegen (OKG-0303) for the treatment of acute infectious conjunctivitis.

The first patient was dosed at Ambade Eye Hospital in Nagpur, India, following authorization of the multicenter clinical study by India's Central Drugs Standard Control Organisation (CDSCO).

Treyegen is an investigational ophthalmic therapy combining 3 agents with complementary mechanisms of action: ranpirnase, an investigational antiviral; tobramycin, a broad-spectrum antibacterial agent; and oxymetazoline, intended to reduce ocular congestion.

The EMERALD trial is designed to assess the safety and potential clinical efficacy of the combination in patients with acute infectious conjunctivitis.

“Dosing the first patient in EMERALD represents an important milestone in Okogen’s development of Treyegen,” said Joshua Moriarty, CEO of Okogen. “Physicians need a therapy designed for the uncertainty they face at the first visit, when the cause of infection is often unknown.”

Acute infectious conjunctivitis can result from viral or bacterial pathogens, which frequently produce overlapping clinical signs and symptoms. Consequently, ophthalmologists may need to initiate treatment before laboratory confirmation of the underlying pathogen is available.

Okogen is developing Treyegen to address this diagnostic uncertainty through a single formulation incorporating antiviral, antibacterial, and symptom-relieving components. The company noted that no FDA-approved antiviral therapies are currently specifically indicated for adenoviral conjunctivitis, a common cause of infectious conjunctivitis.

The EMERALD trial represents the clinical evaluation of Okogen's host-directed antiviral approach, with findings expected to inform further development of Treyegen as a potential treatment for acute infectious conjunctivitis.

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Octant Receives FDA Orphan Drug Designation for OCT-980 for the Treatment of Retinitis Pigmentosa https://eyewire.news/news/octant-receives-fda-orphan-drug-designation-for-oct-980-for-the-treatment-of-retinitis-pigmentosa Fri, 30 Oct 2026 15:59:03 GMT https://eyewire.news/news/octant-receives-fda-orphan-drug-designation-for-oct-980-for-the-treatment-of-retinitis-pigmentosa Key Takeaways

  • The FDA has granted Orphan Drug Designation to Octant’s OCT-980 for the treatment of retinitis pigmentosa (RP)
  • The designation includes rhodopsin-associated autosomal dominant RP, the indication for which OCT-980 is currently being developed
  • The investigational oral small molecule is currently being evaluated in a phase 1/2 clinical study

Octant, a clinical-stage drug discovery company developing correctors for protein misfolding diseases, announced that the FDA has granted Orphan Drug Designation to OCT-980 for the treatment of retinitis pigmentosa (RP). The designation includes rhodopsin-associated autosomal dominant RP (RHO-adRP), the indication for which OCT-980 is currently being developed.

According to the company, OCT-980 is an investigational oral small molecule designed to address RHO-adRP at its source by correcting the underlying protein misfolding and restoring proper cellular trafficking of rhodopsin. It is currently being evaluated in a phase 1/2 clinical study.

“People with RHO-adRP are living with progressive vision loss and no approved treatment options today,” said Sri Kosuri, cofounder and CEO of Octant, in a company press release. “This designation is another step forward as we advance OCT-980. With our phase 1b/2 study underway at US sites, we are focused on generating the clinical data needed to establish OCT-980 as an oral, disease-modifying option for RHO-adRP.”

RP is a group of inherited retinal disorders that cause progressive vision loss and can ultimately lead to blindness. RHO-adRP is caused by disease-associated variants in the RHO gene. Many of these variants reportedly result in misfolded and mistrafficked rhodopsin proteins that fail to localize properly within photoreceptor cells, contributing to progressive vision loss.

The FDA grants Orphan Drug Designation to drugs intended to treat rare diseases or conditions. The designation provides certain development incentives, including potential tax credits for qualified clinical trials, exemption from certain FDA application fees, and eligibility for 7 years of US market exclusivity following regulatory approval, subject to applicable requirements.

More information about the OCT-980 phase 1/2 clinical study is available on ClinicalTrials.gov (NCT07408232).

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VisioSurgical Solutions Begins Development of Compact Surgical Robot for Retinal Surgery https://eyewire.news/news/visiosurgical-solutions-launches-starts-development-of-compact-surgical-robot-for-retinal-surgery Fri, 30 Oct 2026 14:45:40 GMT https://eyewire.news/news/visiosurgical-solutions-launches-starts-development-of-compact-surgical-robot-for-retinal-surgery Key Takeaways

  • VisioSurgical Solutions announced its launch and the start of development of a compact surgical robot for retinal surgery with Kaleidoscope Innovation
  • The founding team of VisioSurgical Solutions includes Marc de Smet, MD, PhD; Patricia Zilliox, PhD; and Bryan Robb, MBA
  • The system is designed to deliver precision better than 10 µm, with tremor filtering, motion scaling, and force limits that protect the retina

VisioSurgical Solutions (VSS) announced its launch and the start of development of a compact surgical robot for retinal surgery. The Swiss company has selected Kaleidoscope Innovation, a medical device design and engineering firm based in Cincinnati, to develop the robotic platform under the direction of VSS Founder and CEO Marc de Smet, MD, PhD.

Dr. de Smet is a practicing retinal and cataract surgeon who was a cofounder and chief medical officer of Preceyes, whose system performed the first robot-assisted retinal surgery in a human. The company was acquired by Carl Zeiss Meditec in 2022. Dr. de Smet built the first prototype retinal surgery robot with Eindhoven University of Technology, and serves as cochair of the Collaborative Community on Ophthalmic Innovation robotics committee. VSS Cofounder Patricia Zilliox, PhD, is the former CEO and president of Eyevensys, the former chief drug development officer of the Foundation Fighting Blindness Clinical Research Institute, and the former head of clinical development at Alcon. VSS Cofounder Bryan Robb, MBA, specializes in business development and corporate finance. Previously, he worked at AC Immune in Lausanne, Switzerland, and served as a biotechnology venture capital analyst in the United States.

VSS said it is developing a compact robotic head that uses the surgeon’s existing microscope and intraoperative imaging. The system is designed to deliver precision better than 10 µm, with tremor filtering, motion scaling, and force limits that protect the retina.

“Retinal surgery works at a scale where the human hand sets the limit,” Dr. de Smet said in a company news release. “Our first robot showed that a machine can operate inside the eye with a precision no hand achieves. With VSS we are making that precision compact enough for any operating room, and we are building it so that the surgeon stays in control: the robot extends the surgeon’s hands; it does not replace them.”

“Retinal surgery presents a compelling opportunity for surgical robotics, where precision, control, and consistency are paramount," added Ben Ko, CEO of Kaleidoscope Innovation. "Having previously collaborated with Dr. de Smet and Dr. Zilliox on innovative ophthalmic surgical technologies, we are excited to develop this platform with them. By combining their deep clinical expertise with Kaleidoscope’s product development capabilities across surgical and industrial robotics, we can address the unique technical challenges of retinal surgery and advance what is possible in the operating room.”

According to VisioSurgical, development will begin with the concept phase, a first prototype, and a confirmation study of the approach to retinal surgery without vitrectomy. The first applications will be retinal surgery and the precise delivery of gene and cell therapies to the retina, followed by glaucoma and cataract applications. VSS stated that it is currently raising a seed round to initiate the concept phase and the first prototype and that a later Series A will fund development of the robot through to clinical readiness.

For more information, visit https://visiosurgicalsolutions.com.

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Lenz Therapeutics Announces Major Restructuring and CEO Transition https://eyewire.news/news/lenz-therapeutics-announces-major-restructuring-and-ceo-transition Fri, 30 Oct 2026 13:23:52 GMT https://eyewire.news/news/lenz-therapeutics-announces-major-restructuring-and-ceo-transition Key Takeaways

  • Lenz Therapeutics announced a major strategic reorganization and CEO transition that will shed 75% of its workforce 

  • The reorganization is designed to reduce operating expenses and prioritize consumer marketing for its presbyopia treatment

  • Vizz generated $2.6 million in third-quarter sales, with paid prescriptions increasing 51% sequentially

Lenz Therapeutics announced a major strategic reorganization and CEO transition designed to reduce operating expenses and prioritize consumer marketing for its presbyopia treatment. The reorganization, announced during the company's third-quarter earnings, comes as the company reported a 50% increase in third-quarter 2026 sales of its presbyopia drop Vizz (aceclidine ophthalmic solution 1.44%).

According to a securities filing with the SEC, Lenz will trim 75% of its workforce, leaving a 40-person team behind. 

“We are focusing our commercial organization and investment on initiatives we believe will most effectively increase consumer awareness, access and adoption, while improving capital efficiency and supporting Vizz's continued growth. I am encouraged by the growing third-quarter consumer demand that is continuing into the fourth quarter, and excited about the opportunities ahead for Lenz," said Lenz President and CEO Eef Schimmelpennink.

Lenz said the restructuring is expected to reduce projected 2027 annualized operating expenses by more than 50%, targeting $70 million to $75 million, excluding stock-based compensation. The company anticipates approximately $5 million in one-time restructuring charges, with substantially all activities completed during the fourth quarter of 2026.

Mr. Schimmelpennink said he will step down December 1, 2026, with current CFO Dan Chevallard assuming the role of interim president and CEO. Schimmelpennink will remain a strategic advisor into 2027.

“After nearly six years leading Lenz and more than 25 years in the biotechnology industry, I have decided to transition from my role as CEO effective December 1, 2026, to devote more time to other passions. I am very proud of the team we have built, the culture we have created and the successes we have achieved together," he said. 

Lenz received FDA approval for Vizz in July 2025 as the first and only FDA-approved aceclidine-based eye drop for the treatment of presbyopia in adults. Following the approval, Mr. Schimmelpennink spoke with EyewireTV about the first-of-its-kind drop. 

The company reported $2.6 million in product sales for the quarter ended September 30, 2026, based on more than 38,000 paid prescriptions, representing sequential increases of approximately 50% and 51%, respectively. Prescription growth occurred across ePharmacy and retail channels, supported by the July launch of a telehealth prescribing option that connects patients with independent licensed eye care providers and offers home delivery. Telehealth accounted for more than half of the incremental prescriptions during the quarter.

Lenz also reported additional regulatory submissions for Vizz in Saudi Arabia, Malaysia, and Vietnam during the third quarter, bringing its total number of regulatory filings outside the United States to 11.

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Oculis to Present Privosegtor Data at Upcoming Ophthalmology and Neurology Conferences https://eyewire.news/news/oculis-to-present-privosegtor-data-at-upcoming-ophthalmology-and-neurology-conferences Thu, 29 Oct 2026 15:53:40 GMT https://eyewire.news/news/oculis-to-present-privosegtor-data-at-upcoming-ophthalmology-and-neurology-conferences Oculis Holding AG announced upcoming presentations highlighting the neuroprotective potential of privosegtor and its ongoing PIONEER registrational program at the 6th Asia-Pacific Ophthalmic Innovation Society (APOIS) Congress and CNS Summit.

Privosegtor is an investigational peptoid small-molecule candidate designed to cross the blood-brain and retinal barriers and is being developed for optic neuritis and other optic neuropathies.

At the CNS Summit, Oculis will present findings from the phase 2 ACUITY trial, a multicenter, randomized, placebo-controlled, double-masked study evaluating privosegtor in patients with acute optic neuritis. According to the company, the trial demonstrated improvements in visual function, supported by preservation of retinal anatomy, including the ganglion cell-inner plexiform layer and retinal nerve fiber layer, as well as reductions in blood neurofilament levels.

Privosegtor has received Breakthrough Therapy designation from the FDA and Priority Medicines designation from the European Medicines Agency for optic neuritis, according to Oculis.

Oculis is advancing privosegtor through its PIONEER registrational program, which includes two trials in optic neuritis and one in nonarteritic anterior ischemic optic neuropathy. PIONEER-1 is currently enrolling patients with acute-onset optic neuritis, including those with and without multiple sclerosis.

The company also anticipates clearance of an investigational new drug application for privosegtor in acute multiple sclerosis relapses in the fourth quarter of 2026.

Details of the presentations are as follows:

2026 APOIS Congress

  • Session: Next Waves Technologies II
    • Presenter: Riad Sherif, MD, chief executive officer, Oculis
    • Date/Time: November 1, 2026, 10:30 AM-12:30 PM KST
    • Location: Grand Walkerhill, Seoul, South Korea

CNS Summit

  • Abstract: Improved Low Contrast Visual Acuity, Reduction in Retinal Ganglion Cell Loss, and Neurofilaments-light with Privosegtor in Acute Optic Neuritis: Results from a Multicenter, Randomized, Placebo-Controlled, Double-Masked Trial
    • Presenter: Aaron Tansy, MD, vice president and development franchise head, neurology, Oculis, on behalf of the authors
    • Date/Time: November 2 and 3, 2026, 5:00 PM-7:00 PM EDT
    • Location: Encore Boston Harbor, Everett, Massachusetts
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Kiora Plans Multinational Phase 3 CRAO and Phase 2b NAION Trials of KIO-401 https://eyewire.news/news/kiora-plans-phase-3-crao-and-phase-2b-naion-trials-of-kio-401 Thu, 29 Oct 2026 14:13:44 GMT https://eyewire.news/news/kiora-plans-phase-3-crao-and-phase-2b-naion-trials-of-kio-401 Key Takeaways

  • Kiora has obtained exclusive rights outside Asia to KIO-401, an investigational oral calpain inhibitor being developed for CRAO and NAION
  • Clinical studies conducted in Japan reported improvements in visual acuity, including statistically significant findings in a phase 2a comparison with an observational registry and a phase 3 subgroup of patients who were legally blind at baseline
  • Kiora plans a multinational phase 3 CRAO trial beginning in 2027 and a phase 2b NAION trial in 2028

Kiora Pharmaceuticals has obtained exclusive development and commercialization rights outside Asia to KIO-401 (mitucapistat), an investigational oral calpain inhibitor for central retinal artery occlusion (CRAO), from Senju Pharmaceutical. The company plans to initiate a multinational phase 3 registration trial in CRAO in 2027 and expand development into nonarteritic anterior ischemic optic neuropathy (NAION).

Announcing the agreement, Shuhei Yoshida, president and CEO of Senju Pharmaceutical, said, “The clinical results generated in Japan support continued global development of this compound as a potential treatment for acute retinal ischemia.”

Senju has completed phase 2a and phase 3 clinical studies of the compound, designated SJP-0008 in Japan. In a phase 2a study, KIO-401 demonstrated a statistically significant improvement from baseline in ETDRS visual acuity compared with outcomes from a prospective observational registry (P = .0398), according to Kiora. A subsequent randomized, double-masked phase 3 study demonstrated improvement in BCVA. According to Kiora, the study showed a statistically significant improvement among patients who were legally blind at baseline under World Health Organization criteria (P = .0195).

KIO-401 is designed to inhibit activated calpain, a calcium-dependent protease implicated in cellular injury following ischemia. According to Kiora, inhibiting calpain may help limit downstream cellular damage and preserve visual function following ischemic injury.

The planned multinational phase 3 CRAO trial will be randomized, double-masked, and controlled, with an anticipated enrollment of more than 100 patients. The final study design, including the primary endpoint and enrollment criteria, remains subject to regulatory discussions. Trial initiation is contingent on funding and regulatory alignment.

Kiora also plans to initiate a phase 2b trial of KIO-401 in NAION in 2028, subject to funding and regulatory considerations. The company also identified glaucoma and other ophthalmic disorders involving calpain-mediated injury as potential future areas of investigation.

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Tarsus Pharmaceuticals Names Neera Clase as CCO https://eyewire.news/news/tarsus-pharmaceuticals-names-neera-clase-as-cco Thu, 29 Oct 2026 13:10:43 GMT https://eyewire.news/news/tarsus-pharmaceuticals-names-neera-clase-as-cco Key Takeaways

  • Neera Clase, who has served as interim CCO of Tarsus Pharmaceuticals since July, was appointed as the company’s CCO.
  • She will lead Tarsus’ commercial strategy and execution, continuing her focus on expanding the reach of Xdemvy (lotilaner ophthalmic solution, 0.25%).

Tarsus Pharmaceuticals announced the appointment of Neera Clase as chief commercial officer (CCO), effective November 1. Ms. Clase has served as interim CCO of Tarsus since July and previously served as senior vice president of market access.

“Neera has the right experience and vision to lead us into our next chapter of growth,” said Bobby Azamian, MD, PhD, CEO and chairman of Tarsus. “She has been instrumental in creating a new market for Xdemvy, building our commercial team and capabilities from the earliest days, and securing the broad coverage that has made this launch a standout in eye care. She brings sound judgment, credibility, and a deep understanding of our business. As Tarsus expands into retina and advances its broader pipeline, I am confident in Neera’s ability to build on Xdemvy’s success and bring future innovation to more patients.”

As CCO, Ms. Clase will lead Tarsus’ commercial strategy and execution, with a primary focus on expanding the reach of Xdemvy (lotilaner ophthalmic solution, 0.25%) among eye care professionals and patients. These include two phase 3 retina programs, gildeuretinol (ALK-001), an investigational treatment for Stargardt disease, and IRX-101, an investigational ocular antiseptic; and two phase 2 programs, TP-04 for ocular rosacea and TP-05 for Lyme disease prevention.

“When I joined Tarsus, we were a small team with a first-in-class medicine and a conviction that we could make a difference for millions of patients living with Demodex blepharitis,” said Ms. Clase. “Helping make Xdemvy accessible to patients has been one of the most rewarding experiences of my career. I believe Xdemvy has the potential to exceed $2 billion in peak sales by reaching more of the patients who need treatment, and delivering on that opportunity is my first priority. As our pipeline advances, I’m excited to engage new communities of physicians and patients and apply what we’ve learned with Xdemvy to the programs ahead.”

Ms. Clase has more than 25 years of biopharmaceutical experience across sales, marketing, market access, reimbursement, and commercialization. Previously, she held senior commercial and market access leadership positions at Acadia Pharmaceuticals, Relypsa, and Abbott Laboratories. She has helped commercialize more than 10 products across multiple therapeutic areas, including several first-in-class therapies. She holds a Bachelor of Arts in life sciences and psychology from Indiana State University and a Master of Social Work from Indiana University.

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Centre for Sight Founder Sheraz Daya, MD, Receives AAO Lifetime Achievement Honor Award https://eyewire.news/news/centre-for-sight-founder-sheraz-daya-md-receives-aao-lifetime-achievement-honor-award Wed, 28 Oct 2026 20:22:37 GMT https://eyewire.news/news/centre-for-sight-founder-sheraz-daya-md-receives-aao-lifetime-achievement-honor-award Key Takeaways

  • Ophthalmic surgeon Sheraz Daya, MD, was awarded the 2026 Life Achievement Honor Award by the AAO for his contribution to eye care.
  • The honor is awarded to ophthalmologists who have demonstrated sustained commitment to the profession through education, leadership, committee service, and participation in the AAO.
  • Dr. Daya is the founder of Centre for Sight, a specialist eye care organization based in the United Kingdom.

Centre for Sight Founder and Medical Director Sheraz M. Daya, MD, FACP, FACS, FRCS(Ed), FRCOphth, was awarded the 2026 Life Achievement Honor Award by the AAO in recognition of his contribution to the advancement of eye care and the lives of patients.

The accolade is awarded to ophthalmologists who have demonstrated sustained commitment to the profession through education, leadership, committee service, and participation in the AAO. For Dr. Daya, the honor coincides with Centre for Sight’s 30th anniversary. Since its founding in 1996, the specialist eye care organization has been internationally recognized for its work in advanced cataract surgery, laser vision correction, corneal transplantation, and complex ophthalmic treatment.

Dr. Daya’s career has combined clinical practice with research, innovation and education. He introduced LASIK in the United Kingdom in 1994 and has performed more than 30,000 cataract procedures throughout his career. After training and practicing in the United States, he returned to the United Kingdom to lead the Corneoplastic Unit and Eye Bank at Queen Victoria Hospital in East Grinstead. His work in corneal and stem cell treatments includes helping to restore the sight of acid attack survivor Katie Piper.

“To receive this recognition from the AAO is an enormous honor, particularly because the academy has played such an important role throughout my professional life. Ophthalmology has changed beyond recognition during my career, but the purpose of our work remains the same: to improve the quality of people’s lives through better vision,” Dr. Daya said. “I have been fortunate to work alongside extraordinary colleagues, researchers, and surgeons across the world. Innovation is never the achievement of one person alone, and I see this award as recognition of the shared commitment to advancing treatment, challenging established thinking, and achieving the best possible outcomes for patients.”

Over three decades, Centre for Sight has continued to invest in new technologies, research, and tailored patient care, bringing together specialist teams across its locations in East Grinstead, Surrey, and London. The organization’s focus remains on combining surgical advances with rigorous clinical standards and personalized treatment.

“As Centre for Sight marks its 30th anniversary, this award is a wonderful opportunity to reflect on how far eye care has progressed … it is also a reminder of how much more we can achieve through research, collaboration, and a relentless focus on patients,” Dr. Daya said.

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Nacuity Pharmaceuticals Doses First Patient in Phase 3 Trial of NPI-001 for the Treatment of RP Associated with Usher Syndrome https://eyewire.news/news/nacuity-pharmaceuticals-announces-first-patient-dosed-in-global-confirmatory-phase-3-trial-of-npi-001-for-the-treatment-of-rp-associated-with-usher-syndrome Wed, 28 Oct 2026 18:53:00 GMT https://eyewire.news/news/nacuity-pharmaceuticals-announces-first-patient-dosed-in-global-confirmatory-phase-3-trial-of-npi-001-for-the-treatment-of-rp-associated-with-usher-syndrome Key Takeaways

  • The first patient has been dosed in Nacuity Pharmaceuticals’ global, confirmatory phase 3 clinical trial of NPI-001 tablets for the treatment of retinitis pigmentosa associated with Usher Syndrome.
  • NPI-001 is a proprietary, GMP-grade formulation of N-acetylcysteine amide (NACA) tablets being developed to address diseases driven by oxidative stress.
  • There are currently no approved therapies that slow photoreceptor degeneration in patients with retinitis pigmentosa associated with Usher syndrome.

Nacuity Pharmaceuticals announced that the first patient has been dosed in the global, confirmatory phase 3 SLO-RP Preserve clinical trial of NPI-001 (N-acetylcysteine amide) tablets for the treatment of retinitis pigmentosa (RP) associated with Usher Syndrome.

RP associated with Usher syndrome is a rare, progressive inherited retinal disease that leads to irreversible vision loss and currently has no approved therapies that slow photoreceptor degeneration. The SLO-RP Preserve trial is designed to evaluate whether NPI-001 can slow disease progression by reducing photoreceptor loss.

The 24-month, randomized, double-masked study (NCT07710196) will enroll up to 80 adult participants who will self-administer an NPI-001 or a placebo oral tablet twice daily and complete nine in-clinic visits over approximately 2 years.

“Building on the encouraging findings observed to date, we look forward to further evaluating the potential of NPI-001 to slow disease progression and preserve vision in this phase 3 trial," said Mark Pennesi, MD, PhD, chief medical officer and director of the Inherited Retinal Degeneration Center at the Retina Foundation of the Southwest in Dallas and principal investigator of the SLO-RP Preserve trial.

NPI-001 is a proprietary, GMP-grade formulation of N-acetylcysteine amide (NACA) tablets being developed to address diseases driven by oxidative stress.

“Dosing the first patient in our first phase 3 trial marks a significant milestone for Nacuity and, more importantly, for the Usher syndrome community,” said Halden Conner, chairman, CEO, and cofounder of Nacuity. “We look forward to advancing NPI-001 through this confirmatory study as we work toward delivering a potential disease-modifying therapy for patients with RP associated with Usher syndrome. We’re grateful for our continued collaboration with the Retina Foundation of the Southwest and to the investigators, patients, and families making this study possible.”

The SLO-RP Preserve trial is now enrolling patients at the Inherited Retinal Degeneration Clinic at the Retina Foundation of the Southwest and other sites across the United States and Australia.

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University of Waterloo Research Reveals Guttata-Like Structures Contribute to Corneal Cell Loss https://eyewire.news/news/guttata-like-structures-contribute-to-corneal-cell-loss Wed, 28 Oct 2026 16:53:19 GMT https://eyewire.news/news/guttata-like-structures-contribute-to-corneal-cell-loss Key Takeaways

  • Researchers discovered how abnormal collagen excrescences, or guttata, on the Descemet membrane contribute to Fuchs endothelial corneal dystrophy (FECD), a leading cause of corneal blindness.
  • Study findings suggest that guttata-like structures induce human corneal endothelial cell loss, with FECD-derived cells more sensitive to this stress compared with normal cells.
  • These findings could pave the way for alternative treatment strategies for FECD and potentially reduce the need for corneal transplants in some patients.

Researchers from the University of Waterloo have discovered how physical microstructures on the Descemet membrane contribute to Fuchs endothelial corneal dystrophy (FECD), a leading cause of corneal blindness and corneal transplantation worldwide. With donated corneas in short global supply, the finding could lead to alternative treatment strategies and reduce the need for corneal transplants in some patients.

The study, Corneal guttata-like microtopography induces corneal endothelial cell apoptosis by modulating mechanotransduction, was recently published in Cell Biomaterials.1

“Our ultimate goal is the development of alternative treatments, which could mean fewer people will need transplants for corneal blindness due to Fuchs endothelial corneal dystrophy in the future,” said Evelyn Yim, PhD, PEng, a chemical engineering professor at Waterloo and the Canada Research Chair in Nanomaterials for Regenerative Medicine.

FECD is characterized by human corneal endothelial cell (HCEC) loss, which causes the cornea to become cloudy and leads to impaired vision, and the formation of discrete abnormal collagen excrescences, or guttata, on the Descemet membrane. Scientists have known for years that these microstructures develop in eyes with FECD, but they were thought to be a sign of the disease and not a cause of further damage.

“When the cornea becomes cloudy, the condition is in an advanced stage,” said Lexie Xi, a Waterloo PhD candidate in chemical engineering and first author of the study. “We aim to understand the disease mechanism to develop better alternative treatments.”

Researchers utilized an in vitro synthetic-guttata model to investigate the mechanobiological effect of guttata microtopography on HCEC apoptosis. Study findings suggest that guttata-like structures can induce HCEC apoptosis, and FECD-derived cells are more sensitive to guttata-induced topographical stress compared with normal HCECs. Furthermore, topography-induced apoptosis is mediated by enhanced cytoskeletal contractility.

These findings could help researchers develop new ways to treat FECD by addressing the underlying causes of cell damage. Potential approaches include cell-based therapies to replace damaged cells or procedures to remove guttata that contribute to cell death. Although further research is needed, such strategies could eventually reduce the need for corneal transplants in some patients.

The research team also included Stephan Ong Tone, MDCM, PhD, FRCSC, a corneal surgeon at the Sunnybrook Research Institute in Toronto, and Gary S.L. Peh, BSc, GradDip Reprod Sci, PhD, and Jodhbir S. Mehta, MBBS, FRCOphth, FRCS(Ed), FAMS, PhD, from the Singapore Eye Research Institute.

Reference

  1. Xi LWQ, Enkhbat M, Jain D, et al. Corneal guttata-like microtopography induces corneal endothelial cell apoptosis by modulating mechanotransduction. Cell Biomaterials. 2026; 100510. doi:10.1016/j.celbio.2026.100510
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Nasal Spray Improves Tear Film Stability and DED Symptoms https://eyewire.news/news/nasal-spray-improves-tear-film-stability-and-ded-symptoms Tue, 27 Oct 2026 18:33:14 GMT https://eyewire.news/news/nasal-spray-improves-tear-film-stability-and-ded-symptoms Key Takeaways

  • A phase 4 study found treatment of dry eye disease with varenicline nasal spray (Tyrvaya, Harrow) led to a mean improvement in patients’ dry eye questionnaire score and eye dryness score compared with patients in the vehicle group.
  • The mean change in noninvasive tear break-up time (70% vs 30%) was not significantly different between the groups.
  • In the treatment group, 88% reported sneezing as an adverse event compared with 4% of the vehicle group.

Results from the phase 4 TSUNAMI clinical trial (NCT05514041) of varenicline nasal spray (Tyrvaya, Harrow) for the treatment of dry eye disease (DED) found a statistically significant improvement in the dry eye questionnaire score (DEQS; 23% vs 12%) and eye dryness score (EDS; 44% vs 27%) for patients treated with the varenicline nasal spray compared with the vehicle group.1

In the prospective, placebo-controlled study, 50 patients with DED were randomly assigned to receive either varenicline nasal spray 0.03 mg or its vehicle twice daily for 28 days. In addition to improvements in DEQS and EDS, the researchers noted a statistically significant higher mean corneal and conjunctival fluorescein staining (~50% vs ~20%,) in treated patients versus the vehicle group; while the mean change in noninvasive tear break-up time (70% vs 30%) was not significantly different between the groups, it was higher in the varenicline compared with vehicle (2.02 ± 3.54 vs 1.18 ± 2.42). They found no difference in surface asymmetry index and surface regularity index between the groups.1

All 50 patients completed treatment without discontinuation. All adverse events—such as sneezing (88% of treated patients vs 4% of the vehicle group), burning sensation (three patients in the treatment arm), runny nose (one patient in the treatment arm), and nosebleed (one patient in each group)—were mild and resolved without additional intervention.1

The researchers concluded that the results suggest improving tear production with a nasal spray can help promote tear film stability and ocular homeostasis over time.1

1. Stephenson PD, Matossian C. The effect of varenicline nasal spray on the signs and symptoms of dry eye disease and tear film stability: a randomized controlled trial. Clin Ophthalmol. 2026;20:610688. doi: 10.2147/OPTH.S610688

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Glaukos Announces License Agreement with RevOpsis Therapeutics for Retinal Therapy https://eyewire.news/news/glaukos-announces-license-agreement-with-revopsis-therapeutics-for-retinal-therapy Tue, 27 Oct 2026 14:21:11 GMT https://eyewire.news/news/glaukos-announces-license-agreement-with-revopsis-therapeutics-for-retinal-therapy Key Takeaways

  • Glaukos and RevOpsis Therapeutics have entered into an exclusive license agreement to develop and commercialize RO-104, a tri-specific biologic for the treatment for retinal disease
  • The agreement grants Glaukos exclusive rights to the RevMod platform for the discovery and development of up to four additional next-generation biologics
  • RO-104 is designed to simultaneously block VEGF-A and VEGF-C while also potently inhibiting angiopoietin-2

Glaukos announced an exclusive license agreement with RevOpsis Therapeutics to develop and commercialize RO-104, a tri-specific biologic for the treatment of wet age-related macular degeneration (nAMD), diabetic macula edema (DME), diabetic retinopathy (DR), and retinal vein occlusion (RVO). The agreement also grants Glaukos exclusive rights to RevOpsis’ proprietary RevMod platform in geographic atrophy, DME, DR, RVO, and wet AMD for the discovery and development of up to four additional next-generation retinal biologic candidates.

The new therapy is designed to simultaneously block VEGF-A and VEGF-C while also potently inhibiting angiopoietin-2 (Ang-2)—pathways implicated in the progression of retinal vascular diseases. RO-104 has demonstrated superior preclinical efficacy in established animal models when compared with approved anti-VEGF therapeutics.

“This license agreement represents an important validation of our proprietary RevMod platform and our strategy of developing next-generation multi-specific therapeutics for retinal diseases," said Ramanath Bhandari, chairman and chief executive officer of RevOpsis. "Glaukos brings deep ophthalmology expertise and a strong track record of developing and commercializing innovative therapies. We believe this partnership provides an excellent opportunity to help advance our lead asset while expanding our platform into a broader portfolio of potentially transformative retinal treatments."

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Medicare Payment for Balance Ophthalmics’ FSYX https://eyewire.news/news/final-medicare-payment-for-balance-ophthalmics-fsyx Tue, 27 Oct 2026 14:14:11 GMT https://eyewire.news/news/final-medicare-payment-for-balance-ophthalmics-fsyx Key Takeaways

  • Balance Ophthalmics advances commercialization of FSYX, its ocular pressure adjusting pump technology for the treatment of glaucoma.
  • Chris Lee, MS, MBA, joins the company as vice president of clinical to lead post-market research and medical affairs.
  • Under HCPCS Level II code E2403, the FSYX pump is reimbursed as a capped rental at approximately $1,352.58 per month for months for the first 3 months and $1,014.44 per month for months 4 through 13.

Final Medicare payment amounts for Balance Ophthalmics’ FSYX ocular pressure adjusting pump (OPAP) and associated goggles became effective Octobter 1, the company announced.

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

The FDA 510(k) cleared the wireless-enabled FSYX system earlier this year and patient access as Balance moves into broader commercial execution. FSYX is a noninvasive therapy designed to lower IOP during sleep in adults with open-angle glaucoma. The system uses pressure-modulating goggles and a compact pump to apply gentle negative pressure to the eyes, providing an additional approach to IOP reduction. In clinical trials, FSYX demonstrated a 39% mean IOP reduction in nighttime eye pressure with no device-related serious adverse events reported.1 The system transmits patient usage data to the prescribing practice for greater visibility into at-home therapy use.

The company also announced the appointment of Chris Lee, MS, MBA, as vice president of clinical. Mr. Lee will lead Balance’s FDA post-market study in partnership with the clinical research organization True North. He will also lead medical affairs strategy, including key opinion leader engagement, scientific publications, and presence at major ophthalmic and optometric society meetings, while overseeing inbound research interest and helping evaluate future clinical research opportunities.

“As Medicare payment for FSYX takes effect, we are simultaneously building the team and capabilities needed to successfully bring a first-in-kind technology into clinical practice,” said Seph Jensen, chief executive officer of Balance Ophthalmics. “Chris brings a unique combination of ophthalmic clinical research, medical affairs, and commercial experience that aligns directly with where Balance is today. His leadership will be instrumental as we fulfill our post-market commitments, expand our clinical evidence, and work with physicians to establish OPAP as a meaningful new category in glaucoma care.”

1. Ferguson TJ, Samuelson TW, Herndon LW, et al. Negative pressure application by the ocular pressure adjusting pump to lower intraocular pressure in normal-tension glaucoma: HERCULES study. Am J Ophthalmol. 2025;275:121-134. doi: 10.1016/j.ajo.2025.03.030.

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Research Identifies Previously Unrecognized Outflow Pathway https://eyewire.news/news/research-identifies-previously-unrecognized-outflow-pathway Mon, 26 Oct 2026 21:43:06 GMT https://eyewire.news/news/research-identifies-previously-unrecognized-outflow-pathway Key Takeaways

  • Researchers identified a previously unrecognized posterior ocular lymphatic outflow (POLO) pathway connecting the suprachoroidal space to cervical lymph nodes

  • The discovery could advance understanding of glaucoma, age-related macular degeneration, and other ocular diseases, although studies in humans are needed

Researchers from the University of British Columbia and the University of Toronto have identified a previously unrecognized posterior ocular lymphatic outflow (POLO) pathway from the suprachoroidal space to cervical lymph nodes.1

Several methods of advanced imaging were used in adult mice to map how fluid exited the back of the eye and where it went. The findings demonstrated a posterior drainage route through choroidal lymphatic vessels.

Further studies are required to determine how the POLO pathway functions in a human eye and whether changes in this route contribute to ocular diseases. The discovery of the POLO pathway, however, could improve clinicians’ understanding of eye diseases characterized by fluid accumulation, waste buildup, or inflammation and eventually give rise to new treatments for glaucoma, age-related macular degeneration, and other vision-threatening conditions.

Reference

1. Sauntharrajan B, Gupta N, Zhou X, et al. Identification and mapping of a posterior ocular lymphatic outflow (POLO) pathway through choroidal lymphatics. Transl Vis Sci Technol. 2026;15(7):23. doi:10.1167/tvst.15.7.23

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Study Evaluates Sierra Leone’s Cataract Outreach Program https://eyewire.news/news/sierra-leones-cataract-outreach-program-evaluated Mon, 26 Oct 2026 16:04:57 GMT https://eyewire.news/news/sierra-leones-cataract-outreach-program-evaluated Key Takeaways

  • A study recently published in BMJ Open evaluated the first implementation cycle of a comprehensive 3-year cataract outreach program in Sierra Leone
  • The study found that the program has improved patients’ vision-related quality of life
  • The research also highlighted the operational challenges and adaptations necessary to deliver cataract services in resource-constrained settings

In 2025, the Choithram International Foundation in association and Noor Dubai Foundation, a member of Mohammed bin Rashid Al Maktoum Global Initiatives, partnered with Sierra Leone’s Ministry of Health to launch a comprehensive 3-year cataract outreach program. A study recently published in BMJ Open found that the program has improved patients’ vision-related quality of life and highlighted the operational challenges and adaptations necessary to deliver cataract services in resource-constrained settings.1

The study evaluated the program’s first implementation cycle (February–August 2025), during which 9,117 individuals were screened and 1,433 cataract surgeries were performed. Among 271 patients with complete follow-up assessments, vision-related quality of life was found to have improved by an average of 17 points, particularly in the areas of mental health and near- and distance-vision activities. Challenges highlighted by the study included workforce limitations, transportation barriers, incomplete clinical records, and low postoperative follow-up attendance, with only 19% of patients returning at 1 month.

The program’s third cycle is scheduled to run from January to April 2027. Level 1 screenings reportedly began in September, with a focus on rural provinces where access to eye care remains limited.

In a news release, Drs. Gabriel Osei-Anokye and Ving Fai Chan of Queen’s University Belfast stated, “The progress we see in this second year is the careful reflection, rigorous evaluation, and a shared commitment to learning from the first cycle. Our research shows that when cataract programmes use evidence to continually improve how services are delivered, the benefits extend far beyond better vision. People regain mobility, confidence, independence, and the ability to participate more fully in their families and communities. Sierra Leone’s experience shows how strong leadership, continuous learning, and cross-sector collaboration can deliver high-quality outcomes even in challenging settings. Restoring sight is therefore more than a medical intervention; it is about enabling people to regain independence, opportunity, and their place in community life.”

Reference

1. Osei-Anokye G, Rabiu M, Harrison-Williams L, Mattia JG, Chan VF. What are the implementation lessons from a high-volume cataract screening and surgical programme? A mixed-methods implementation evaluation in Sierra Leone. BMJ Open. 2026;16(10):e126880. doi:10.1136/bmjopen-2026-126880

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Bronwyn Brophy O’Connor to Become CEO of Carl Zeiss Meditec Group https://eyewire.news/news/bronwyn-brophy-oconnor-to-become-ceo-of-carl-zeiss-meditec-group Mon, 26 Oct 2026 15:58:25 GMT https://eyewire.news/news/bronwyn-brophy-oconnor-to-become-ceo-of-carl-zeiss-meditec-group Key Takeaways

  • Bronwyn Brophy O’Connor will take over as CEO of Carl Zeiss Meditec on December 1, 2026
  • Ms. Brophy O’Connor will join the company’s executive board with responsibility for the medical technology segment
  • She will assume leadership of Carl Zeiss Meditec Group from Andreas Pecher, who has served as the interim CEO since January 1, 2026

Carl Zeiss Meditec announced that Bronwyn Brophy O’Connor will take over as CEO on December 1, 2026. On the same date, she will join the company’s executive board with responsibility for the medical technology segment. Her appointment was first announced in May 2026. Ms. Brophy O’Connor currently serves as the CEO of the Vitrolife Group, a company based in Gothenburg, Sweden, that is listed on NASDAQ Stockholm in Sweden.

With the start date now confirmed, she will assume leadership of Carl Zeiss Meditec Group from Andreas Pecher, who has served as the interim CEO since January 1, 2026.

“I am delighted to join Carl Zeiss Meditec and the Zeiss Group,” Ms. Brophy O’Connor said in a company press release. “The company combines deep scientific expertise, close customer relationships, and a strong commitment to improving patient care. I look forward to working with our teams and customers to build on these strengths, advance innovation, and successfully shape the next stage of the company’s transformation.”

Dr. Michael Bolle, chairman of the supervisory board of Carl Zeiss, said, “We would like to thank Andreas Pecher, both for his temporary dual role as CEO of the Zeiss Group and interim CEO of Carl Zeiss Meditec, and for providing important momentum during this period. With her excellent skills, Bronwyn Brophy O’Connor will now be able to further advance the strategy and transformation of the medical technology segment forward and contribute to the success of the Zeiss Group.”

Effective December 1, 2026, the management board of Carl Zeiss Meditec will comprise Ms. Brophy O’Connor as CEO and Justus Wehmer as CFO. The executive board of Carl Zeiss will comprise Mr. Pecher (president and CEO), Stefan Müller (CFO), Ms. Brophy O’Connor (head of the Zeiss medical technology segment), Sven Hermann (head of the Zeiss consumer markets segment), Dr. Frank Rohmund (head of the Zeiss semiconductor manufacturing technology segment), and Dr. Marc Wawerla (head of the Zeiss industrial quality & research segment).

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Siloton Secures £8.4 Million Innovate UK Contract to Accelerate Development of Handheld OCT Technology https://eyewire.news/news/siloton-secures-ps84-million-innovate-uk-contract-to-accelerate-development-of-handheld-oct-technology Fri, 23 Oct 2026 15:36:18 GMT https://eyewire.news/news/siloton-secures-ps84-million-innovate-uk-contract-to-accelerate-development-of-handheld-oct-technology Key Takeaways

  • Siloton secured £8.4 million from Innovate UK to accelerate development of its handheld GiraffeOCT retinal imaging system
  • Clinical trials with Sunderland Specialist Eye Hospital will evaluate the in-clinic device, while development of an at-home version continues

UK-baed medtech company Siloton secured an £8.4 million contract from Innovate UK to accelerate development and clinical evaluation of its handheld optical coherence tomography (OCT) system, GiraffeOCT.

The 2-year contract, awarded through Innovate UK's "Contracts for Innovation: Quantum Missions Primer" initiative, will support development of in-clinic and at-home versions of the device. Siloton estimates the funding could shorten its development timeline by up to 2 years.

GiraffeOCT is a binocular-style imaging system designed to make retinal disease detection and monitoring more accessible outside traditional hospital settings. The technology integrates optical components onto a photonic chip smaller than a £1 coin, potentially reducing the size, cost, and complexity associated with conventional OCT equipment.

As part of the project, Siloton will collaborate with Sunderland Specialist Eye Hospital to conduct clinical trials of its in-clinic device. Patients across North East England and North Cumbria will have opportunities to access the technology during development.

York Health Economics Consortium will analyze trial data to refine estimates of potential cost savings for the National Health Service (NHS).

The investment comes amid substantial demand for ophthalmic services in England. According to figures cited by the company, ophthalmology accounted for approximately 9 million NHS outpatient attendances in 2023/24, while nearly 623,000 patients were awaiting appointments at the end of July 2026.

“Winning this Innovate UK contract allows us to accelerate the development of our systems, explore manufacturing and assembly in the UK, and help a groundbreaking new technology be adopted by the NHS more quickly,” said Alasdair Price, CEO of Siloton.

The funding will also support integration of Siloton's second-generation BlueJay photonic chip and expansion of its cloud platform. Separately, the company plans to pursue additional investment to advance CheetahOCT, a next-generation system designed to measure different retinal layers and broaden disease detection capabilities.

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CHMP Recommends European Approval of Fovlussea, a Ranibizumab Biosimilar, for Retinal Diseases https://eyewire.news/news/chmp-recommends-european-approval-of-fovlussea-a-ranibizumab-biosimilar-for-retinal-diseases Fri, 23 Oct 2026 13:39:39 GMT https://eyewire.news/news/chmp-recommends-european-approval-of-fovlussea-a-ranibizumab-biosimilar-for-retinal-diseases Key Takeaways

  • The CHMP recommended EU marketing authorization for Fovlussea across 5 retinal disease indications

  • Fovlussea is a ranibizumab biosimilar with comparable quality, safety, and efficacy to Lucentis.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization for Fovlussea (ranibizumab), a biosimilar to Lucentis, for the treatment of several retinal diseases.

The recommendation, issued October 15, 2026, covers 5 indications, including wet age-related macular degeneration (AMD), diabetic macular edema (DME), proliferative diabetic retinopathy (PDR), retinal vein occlusion (RVO), and choroidal neovascularization (CNV).

Accord Healthcare is the applicant for Fovlussea, which will be available as a 10 mg/mL solution for intravitreal injection.

Fovlussea has demonstrated comparable quality, safety, and efficacy to its reference product, Lucentis, which received European Union authorization on January 22, 2007.

The positive CHMP opinion represents a regulatory milestone for Fovlussea but does not constitute final marketing authorization. The European Commission will make the final decision on authorization. 

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Zeiss Announces Commercial Availability of CT Lucia 621P Monofocal IOL in Japan https://eyewire.news/news/zeiss-announces-commercial-availability-of-ct-lucia-621p-monofocal-iol-in-japan Thu, 22 Oct 2026 15:42:26 GMT https://eyewire.news/news/zeiss-announces-commercial-availability-of-ct-lucia-621p-monofocal-iol-in-japan Zeiss Medical Technology announced the commercial availability of its CT Lucia 621P monofocal IOL in Japan, expanding the company's cataract surgery portfolio in the Japanese market.

The CT Lucia 621P incorporates the proprietary Zeiss Optic Asphericity Concept, designed to account for the natural misalignment between the corneal center and the eye's optical axis. According to the company, this optical design is intended to support consistent visual outcomes across a range of patient profiles.

The lens also features a reinforced optic-haptic junction and step-vaulted C-loop haptics, designed to facilitate centration and maximize direct capsular contact. These structural features are intended to enhance IOL stability and maintain consistent positioning within the capsular bag.

The commercial introduction adds another monofocal IOL option for cataract surgeons in Japan, with design features focused on optical performance, lens centration, and postoperative positional stability.

The IOL will be showcased at the 80th Annual Congress of Japan Clinical Ophthalmology (JCO), scheduled for October 29 to November 1, 2026, in Kyoto, Japan. Additional information about the CT Lucia 621P and its availability in Japan is available through Zeiss Medical Technology.

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Newton Registry Finds Only 12.2% of Glaucoma Patients Undergo Procedural Treatment https://eyewire.news/news/newton-registry-finds-only-122-of-glaucoma-patients-undergo-procedural-treatment Thu, 22 Oct 2026 15:37:10 GMT https://eyewire.news/news/newton-registry-finds-only-122-of-glaucoma-patients-undergo-procedural-treatment Key Takeaways

  • A large US registry study found only 12.2% of patients underwent a glaucoma procedure during an 18- to 36-month observation period

  • The Newton Registry provides a baseline for tracking interventional glaucoma adoption and evaluating treatment patterns in US practices

A large US registry study found that only 12.2% of patients with glaucoma underwent a procedural intervention during an 18- to 36-month observation period, while 56.3% experienced a lapse in glaucoma care exceeding 12 months.

The findings, published October 16, 2026, in Ophthalmology and Therapy, highlight gaps in glaucoma management and provide a baseline for evaluating adoption of interventional glaucoma treatments.1

The study analyzed 724,728 patient encounters involving 157,246 patients and 605 providers across 35 nonacademic ophthalmology practices in the United States. Data were collected between January 2022 and November 2025. Most patients had open-angle glaucoma (82.1%), while 10.5% were classified as glaucoma suspects. Disease severity was categorized as mild in 51.8% of patients, moderate in 13.5%, and severe in 17.8%.

Among glaucoma procedures performed, selective laser trabeculoplasty accounted for the largest proportion (44.4%), followed by stent implantation (25.7%), canaloplasty (12.3%), and goniotomy (12.1%). Traditional filtering procedures were performed less frequently.

The mean follow-up duration was 15.4 months, with more than half of patients experiencing a gap in care exceeding 1 year at their participating practice.

The investigators noted that procedural treatment remained relatively uncommon even among practices that had expressed interest in interventional glaucoma management.

The Newton Registry, established and owned by Glaukos, was developed to characterize real-world treatment patterns and track the adoption of procedural approaches intended to reduce reliance on daily topical medications.

Study limitations included nonrandom practice selection, variable observation periods, and the inability to capture care received outside participating practices. 

The authors concluded that the registry could serve as a benchmark for monitoring changes in interventional glaucoma practice and identifying opportunities to improve continuity of care.

Reference

1. Williams AM, Coleman AL, Stagg B, et al. Characterizing the modern interventional glaucoma treatment paradigm: the Newton Registry. Ophthalmol Ther. Published online October 16, 2026. doi:10.1007/s40123-026-01524-9

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FDA Clears Opus Genetics' IND Application for OPGx-RDH12 Gene Therapy in Leber Congenital Amaurosis https://eyewire.news/news/fda-clears-opus-genetics-ind-application-for-opgx-rdh12-gene-therapy-in-leber-congenital-amaurosis Thu, 22 Oct 2026 15:25:33 GMT https://eyewire.news/news/fda-clears-opus-genetics-ind-application-for-opgx-rdh12-gene-therapy-in-leber-congenital-amaurosis Key Takeaways

  • The FDA cleared Opus Genetics' IND application for OPGx-RDH12, enabling clinical development of the investigational gene therapy for RDH12-LCA

  • A phase 1/2 clinical trial is planned for the fourth quarter of 2026, supported by preclinical findings demonstrating restored RDH12 activity

  • The Global RDH12 Alliance has committed up to $1.6 million to support development through a patient advocacy–industry collaboration

Opus Genetics announced that the FDA has cleared its investigational new drug (IND) application for OPGx-RDH12, an investigational gene therapy for RDH12-associated Leber congenital amaurosis (RDH12-LCA), a rare inherited retinal disease characterized by progressive vision loss beginning in early childhood.

The clearance allows the company to advance OPGx-RDH12 into clinical development, with plans to initiate a phase 1/2 trial in the fourth quarter of 2026. The program represents Opus Genetics' third gene therapy candidate to enter clinical development.

OPGx-RDH12 is an adeno-associated virus (AAV)-based gene therapy designed to deliver a functional copy of the RDH12 gene directly to retinal photoreceptor cells. Preclinical studies in cell and mouse models demonstrated restoration of RDH12 activity and functional improvements, supporting further clinical investigation.

RDH12-LCA affects an estimated 30,900 individuals worldwide. Mutations in the RDH12 gene impair retinal protein function, resulting in early visual deterioration, often accompanied by structural retinal changes by age 2 and rapid disease progression during adolescence.

“We are pleased to advance our third gene therapy pipeline program into clinical development and plan to initiate a phase 1/2 trial this quarter,” said George Magrath, MD, Chief Executive Officer, Opus Genetics. “RDH12-LCA causes progressive vision loss beginning at a very young age, underscoring the urgency of developing treatments that may preserve vision before further deterioration occurs. Receiving IND clearance for OPGx-RDH12 represents an important step toward bringing a potentially transformative gene therapy to children and families affected by this devastating disease. The program is being developed in collaboration with the Global RDH12 Alliance, comprising the US-based RDH12 Fund for Sight and UK-based Eyes on the Future."

Under a strategic partnership established in July 2025, the alliance committed up to $1.6 million toward OPGx-RDH12 development, with funding tied to eligible development activities and milestones.

The collaboration also incorporates patient and family perspectives into the clinical and regulatory development strategy, with the goal of accelerating access to a potential treatment for RDH12-LCA.

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Oculis Reports New Phase 2 Biomarker Data Supporting Neuroprotective Potential of Privosegtor in Optic Neuritis https://eyewire.news/news/oculis-reports-new-phase-2-biomarker-data-supporting-neuroprotective-potential-of-privosegtor-in-optic-neuritis Thu, 22 Oct 2026 13:30:30 GMT https://eyewire.news/news/oculis-reports-new-phase-2-biomarker-data-supporting-neuroprotective-potential-of-privosegtor-in-optic-neuritis Oculis announced new translational biomarker findings from its phase 2 ACUITY trial evaluating Privosegtor in patients with acute optic neuritis (ON), reporting reductions in blood-based markers associated with neuroaxonal injury and glial activation compared with placebo.

The late-breaking findings were presented by Céline Louapre, MD, PhD, of Pitié-Salpêtrière Hospital and Sorbonne University in Paris, during the 10th Joint ACTRIMS-ECTRIMS Meeting, MSToronto 2026.

The biomarker analysis evaluated plasma neurofilament light chain (NfL) and glial fibrillary acidic protein (GFAP), which serve as indicators of neuroaxonal damage and glial responses, respectively. According to Oculis, Privosegtor reduced increases in both biomarkers compared with placebo, with the most pronounced differences observed at early timepoints following acute ON onset.

These findings complement previously reported results from the ACUITY trial demonstrating improvements in visual function and preservation of retinal structure.

In earlier analyses, patients receiving Privosegtor demonstrated an 18-letter improvement in low-contrast visual acuity at Month 3 compared with steroid treatment alone. The company also reported evidence of retinal structural preservation, suggesting a potential protective effect on neural tissue following acute optic nerve inflammation.

Taken together, the functional, structural, and circulating biomarker findings provide additional evidence supporting further investigation of Privosegtor as a potential neuroprotective treatment for ON.

The new analysis adds a blood-based assessment of treatment effects to the clinical and retinal imaging outcomes previously reported in ACUITY. However, the findings remain preliminary, and additional clinical investigation is needed to establish whether these biomarker changes translate into sustained neuroprotection and long-term visual benefits.

At Day 5, the mean increase in plasma NfL was higher in the placebo group than in the Privosegtor group. NfL levels remained stable in the Privosegtor group through Month 6, whereas levels in the placebo group remained elevated above baseline at Month 1 before returning to baseline by Month 6. Lower NfL levels are consistent with reduced structural neuroaxonal injury along the optic nerve pathway.

At Day 5, the mean increase in plasma GFAP was greater in the placebo group than in the Privosegtor group. GFAP levels remained elevated above baseline in the placebo group from Month 1 through Month 6, whereas they remained below baseline in the Privosegtor group over the same period. Lower plasma GFAP levels are consistent with reduced acute reactive astrocytic inflammation and reduction of the secondary neurodegenerative cascade.

“These findings are particularly noteworthy because they provide biological evidence that complements the functional and retinal structural improvements previously observed in ACUITY," said Dr. Louapre, Professor of Neurology at Pitié-Salpêtrière Hospital, Sorbonne University, and presenting author. "The consistent effects across NfL and GFAP suggest that Privosegtor may be influencing multiple pathways involved in tissue injury following acute optic neuritis, supporting its potential as a neuroprotective therapeutic approach. Together, these data deepen our understanding of the treatment's effects and further support continued clinical evaluation.”

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Perfect Corp. Introduces Generative AI Glasses Removal Feature for Virtual Eyewear Try-On https://eyewire.news/news/perfect-corp-introduces-generative-ai-glasses-removal-feature-for-virtual-eyewear-try-on Thu, 22 Oct 2026 13:01:54 GMT https://eyewire.news/news/perfect-corp-introduces-generative-ai-glasses-removal-feature-for-virtual-eyewear-try-on Key Takeaways

  • Perfect Corp.'s generative AI feature enables virtual eyewear try-on while users continue wearing their prescription glasses

  • The technology reconstructs facial features behind existing frames rather than relying on traditional image-masking techniques

  • The upgrade is available across online retail platforms, mobile applications, and in-store kiosks

Perfect Corp. announced an upgrade to its "AI Glasses Virtual Try-On" solution, introducing a generative AI feature that allows consumers to virtually try on eyewear without removing their existing prescription glasses.

The new Glasses Removal feature uses generative AI to digitally remove a user's current glasses from a live camera image and reconstruct the facial features behind them before displaying a new frame. The technology is designed to address a common challenge for individuals with refractive errors who rely on corrective lenses to see their screens clearly.

Unlike earlier virtual try-on technologies that use masking techniques to obscure existing frames, Perfect Corp.'s system reconstructs the eyes, eyebrows, skin texture, and surrounding lighting. According to the company, this approach reduces visual artifacts associated with traditional masking, including blurred areas, frame outlines, and distortions around the eyes.

The feature is designed to accommodate various eyewear styles, including rimless, metal, thick-framed, and tinted glasses, as well as lenses with significant reflections. It supports real-time camera applications and uploaded photographs.

"With generative AI, Glasses Removal rebuilds the face behind the glasses, so shoppers can keep them on and see every new frame clearly and accurately," said Alice Chang, founder and CEO of Perfect Corp.

The upgrade integrates with the company's existing virtual eyewear platform, which includes AI-powered pupillary distance (PD) detection. According to Perfect Corp., the system can estimate PD in approximately 2 seconds to assist with virtual frame sizing. The platform also allows users to view frames from multiple angles and adjust lens tint, frame dimensions, and reflections.

Glasses Removal is now available for integration into e-commerce websites, mobile applications, and in-store kiosks.

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Nanoscope Therapeutics Reports Sustained Visual Responses with OCT-Guided Nonviral Gene Delivery in Preclinical Study https://eyewire.news/news/nanoscope-therapeutics-reports-sustained-visual-responses-with-oct-guided-nonviral-gene-delivery-in-preclinical-study Wed, 21 Oct 2026 15:29:57 GMT https://eyewire.news/news/nanoscope-therapeutics-reports-sustained-visual-responses-with-oct-guided-nonviral-gene-delivery-in-preclinical-study Key Takeaways

  • OCT-guided nonviral delivery enabled targeted opsin gene expression in degenerating retinal tissue

  • Treated mice demonstrated sustained visual responses through 52 weeks, while a focal injury model showed functional recovery within 1 week

  • The investigational platform may support localized treatment of retinal degeneration but requires human evaluation

Nanoscope Therapeutics announced the publication of preclinical findings demonstrating that an optical coherence tomography (OCT)-guided, nonviral gene delivery platform enabled targeted opsin gene expression and sustained visual responses in mouse models of retinal degeneration.

The study, published in Frontiers in Pharmacology, evaluated the company's investigational nano-enhanced optical delivery (NOD) platform, which combines PEGylated plasmonic gold nanorods with low-power near-infrared laser light to deliver multi-characteristic opsin (MCO)-encoding plasmids into inner retinal neurons.

The approach uses OCT imaging to guide gene delivery to specific retinal regions affected by photoreceptor loss, potentially addressing challenges associated with localized degeneration in geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

In rd1 mice, a model of severe photoreceptor degeneration, OCT-guided delivery produced robust MCO expression in inner retinal cells without disrupting retinal structure or altering retinal thickness. Treated mice demonstrated significantly greater electroretinography and visually evoked potential responses than untreated controls, with responses sustained through 52 weeks.

Researchers also evaluated the platform in a focal laser-injury model designed to mimic GA. Localized MCO delivery restored microfocal electroretinography responses in the damaged retinal region within one week of treatment. Biodistribution testing at 12 months showed vector DNA levels in evaluated nonocular tissues comparable to those in controls.

According to Nanoscope, the platform's nonviral design could accommodate larger genetic payloads, including gene-editing constructs, without the packaging-size limitations associated with viral vectors.

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Brepocitinib Meets Primary Endpoints in Two Phase 3 Trials for Noninfectious Uveitis https://eyewire.news/news/brepocitinib-meets-primary-endpoints-in-two-phase-3-trials-for-noninfectious-uveitis Wed, 21 Oct 2026 13:08:58 GMT https://eyewire.news/news/brepocitinib-meets-primary-endpoints-in-two-phase-3-trials-for-noninfectious-uveitis Key Takeaways

  • Brepocitinib met the primary endpoints in both Phase 3 CLARITY trials involving 371 patients with noninfectious uveitis

  • Significant benefits were reported in steroid-free quiescence, retinal vascular leakage, macular edema, and visual functioning

  • No new safety signals were identified, and Priovant plans an FDA submission in the first half of 2027

Roivant and Priovant Therapeutics announced positive topline results from the Phase 3 CLARITY program evaluating brepocitinib in patients with noninfectious uveitis (NIU), reporting that both CLARITY-1 and CLARITY-2 met their primary endpoints.

Brepocitinib also demonstrated statistically significant and clinically meaningful improvements across all key secondary endpoints, including sustained steroid-free quiescence at Week 48, chorioretinal vascular leakage, macular edema resolution, and patient-reported visual functioning.

The CLARITY program enrolled 371 patients across 2 identically designed studies. Participants were randomized 1:1 to receive once-daily brepocitinib 45 mg or placebo during a 48-week double-masked treatment period.

All participants received oral prednisone at 60 mg/day for 2 weeks, followed by a mandatory 6-week taper to zero. The primary endpoint was time to treatment failure, assessed from Week 6 through Week 48.

Time to treatment failure in CLARITY-1 and CLARITY-2 (Kaplan-Meier estimates, brepocitinib vs. placebo) is captured below:

According to the companies, brepocitinib demonstrated consistent benefits across patients with intermediate, posterior, and panuveitis; those with and without previous tumor necrosis factor inhibitor exposure; and multiple disease etiologies, including birdshot chorioretinopathy and sarcoidosis.

“These results from the Phase 3 CLARITY program suggest that brepocitinib could meaningfully change how we treat non-infectious uveitis across multiple etiologies,” said Quan Dong Nguyen, MD, MSc, professor of ophthalmology at Stanford University School of Medicine.

Brepocitinib was generally well tolerated, with most adverse events classified as mild or moderate. Treatment discontinuation due to adverse events occurred in 3% of participants, and no new safety signals were identified.

Priovant plans to submit a supplemental new frug application to the FDA for brepocitinib in NIU during the first half of 2027.

The companies did not provide numerical efficacy results or detailed statistical analyses in the supplied announcement.

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Alcon Acquires Neurotech Pharmaceuticals for $550 Million, Adding Encelto to Retina Portfolio https://eyewire.news/news/alcon-acquires-neurotech-pharmaceuticals-for-550-million-adding-encelto-to-retina-portfolio Wed, 21 Oct 2026 13:02:12 GMT https://eyewire.news/news/alcon-acquires-neurotech-pharmaceuticals-for-550-million-adding-encelto-to-retina-portfolio Key Takeaways

  • Alcon acquired Neurotech Pharmaceuticals for $550 million, with potential additional milestone payments

  • The acquisition adds Encelto, the first FDA-approved treatment for adults with idiopathic MacTel type 2, to Alcon’s retina portfolio

Alcon announced its acquisition of Neurotech Pharmaceuticals for $550 million, expanding its retina portfolio with Encelto (revakinagene taroretcel-lwey), the first and only FDA-approved treatment for adults with idiopathic macular telangiectasia type 2 (MacTel).

The agreement includes potential additional payments contingent on commercial milestones.

Encelto, an encapsulated cell therapy designed for surgical intravitreal implantation, received FDA approval in March 2025 following priority review. The therapy also received Orphan Drug designation and is currently available in the United States.

MacTel is a rare, progressive retinal disease associated with irreversible central vision loss. Approximately 25,000 patients have been diagnosed with MacTel in the United States, with an estimated 2,000 to 3,000 new diagnoses annually.1-3

Encelto continuously releases recombinant human ciliary neurotrophic factor (rhCNTF), a protein that helps protect retinal cells and reduce photoreceptor loss.

“Neurotech's innovative platform sits at the intersection of cell therapy, pharmaceuticals, and surgery, making it a highly complementary addition to our current capabilities and advancing our vision for the future of retinal disease treatment,” said David Endicott, CEO of Alcon. "By combining Neurotech’s groundbreaking science and established commercial footprint with Alcon's global reach and clinical expertise, we can help bring this innovation to more patients whose vision is threatened by MacTel."

The companies say the acquisition combines Neurotech’s cell therapy platform and existing commercial operations with Alcon’s surgical retina capabilities and global distribution network. Alcon indicated that the transaction could support broader patient access to Encelto.

Richard Small, CEO of Neurotech Pharmaceuticals, said Alcon’s commercial capabilities and scientific expertise would help expand access to the treatment.

Alcon expects the acquisition to be modestly accretive to net sales growth and slightly dilutive to core diluted earnings per share in 2027, with accretion expected thereafter.

References

1. Claims dataset analysis (2018-24). Data as of 2023 - Alcon data on file.
2. Starr MR, et al. Ophthalmic Surg Lasers Imaging Retina. 2020;51(5): S35-S42.
3. United States Census Bureau. “Populations and People.” Accessed Jan 2024.

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Envision and VisionServe Alliance Announce 2027 National Conference in Houston https://eyewire.news/news/envision-and-visionserve-alliance-announce-2027-national-conference-in-houston Tue, 20 Oct 2026 13:55:02 GMT https://eyewire.news/news/envision-and-visionserve-alliance-announce-2027-national-conference-in-houston Key Takeaways

  • The 2027 Envision and VisionServe Alliance National Conference will take place May 11-14 in Houston

  • More than 400 professionals are expected to attend, with over 90 hours of education and research programming

  • Proposal submissions close December 12, 2026, and early-bird registration runs through February 20, 2027

Envision and VisionServe Alliance announced that their 2027 National Conference will take place May 11-14, 2027, at the Royal Sonesta Houston Galleria Hotel in Houston, Texas, bringing together professionals across vision rehabilitation, research, and organizational leadership.

Building on their inaugural combined conference in 2026, the organizations expect more than 400 clinical rehabilitation professionals, researchers, executives, and service providers to attend. The event will feature more than 90 hours of programming across as many as six concurrent education and research tracks.

Sessions will address vision research and technology, clinical best practices, leadership and organizational development, and strategies to improve patient care and outcomes. Programming will include clinical education sessions, panel discussions, symposia, workshops, and research presentations.

“VisionServe is thrilled to again collaborate with Envision to offer powerful education opportunities for leaders in the Vision Rehabilitation field,” said Lee Nasehi, president and CEO of VisionServe Alliance.

The 2026 conference attracted 371 professionals representing nine disciplines and featured 73 clinical sessions, 89 speakers, and 47 sponsors and exhibitors.

“The value of this conference lies in connecting research and education with everyday practice,” said Michael Epp, manager of professional education at Envision. “By bringing together clinical professionals, researchers, and organizational leaders, we create opportunities to learn from one another and explore practical approaches that support independence and quality of life for people who are blind or have low vision.”

Early-bird registration is open through February 20, 2027, with additional discounts available for organizations registering three or more team members.

Envision and VisionServe Alliance are also accepting proposals for clinical education sessions, panels, symposia, workshops, and research presentations. The submission deadline is December 12, 2026.

Additional information about registration and proposal submissions is available through the conference organizers.

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RxSight Appoints Taryn Conway, Frank Shields to Commercial Leadership Positions https://eyewire.news/news/rxsight-appoints-taryn-conway-frank-shields-to-commercial-leadership-positions Tue, 20 Oct 2026 13:48:04 GMT https://eyewire.news/news/rxsight-appoints-taryn-conway-frank-shields-to-commercial-leadership-positions Key Takeaways

  • RxSight appointed Taryn Conway as chief commercial officer and Frank Shields as executive vice president of sales and commercial strategy

  • The appointments support efforts to expand customer engagement, strengthen practice support, and increase adoption of Light Adjustable Lens technology

RxSight announced the appointments of Taryn Conway as chief commercial officer and Frank Shields as executive vice president of sales and commercial strategy as part of a broader initiative to strengthen commercial execution and expand adoption of its Light Adjustable Lens (LAL) technology.

According to RxSigfht, the appointments support the company's ongoing commercial transformation, which includes expanding and realigning its field organization to increase customer engagement, improve practice support, and address barriers to broader utilization of LAL technology.

“Over the past several months, we have prioritized investment to strengthen our commercial organization, and the appointments of Taryn and Frank are another important step in that process,” said Aziz Mottiwala, president and CEO of RxSight. “Their extensive experience in eye care and track record of driving the adoption of innovative technologies will be instrumental as we advance the next phase of our commercial strategy, with a greater emphasis on customer engagement and utilization.”

Ms. Conway brings more than 20 years of commercial leadership experience across eye care, pharmaceuticals, and medical aesthetics. Most recently, she served as vice president of medical and scientific affairs at Bausch + Lomb, overseeing medical strategy for its pharmaceutical and consumer businesses.

Previously, Ms. Conway was general manager of aesthetics at Revance Therapeutics, where she developed a commercial organization and led the launch of two product lines. She also held senior leadership positions at Allergan, focusing on ophthalmology, physician engagement, and market development.

Mr. Shields brings more than 30 years of experience in ophthalmology sales and commercial leadership. Before joining RxSight, he served as head of US surgical glaucoma at Bausch + Lomb following its acquisition of Elios Vision, where he was president.

His previous experience includes sales leadership positions at Ivantis, Revision Optics, and Bausch + Lomb, spanning cataract, refractive, and glaucoma technologies.

According to RxSight, the leadership appointments and organizational changes are intended to strengthen relationships with ophthalmic practices and provide additional support for integrating LAL technology into clinical workflows.

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EyePoint to Shift Focus, Cut Workforce Following Phase 3 Duravyu Results https://eyewire.news/news/eyepoint-to-cut-workforce-by-53-following-phase-3-duravyu-results Tue, 20 Oct 2026 13:42:52 GMT https://eyewire.news/news/eyepoint-to-cut-workforce-by-53-following-phase-3-duravyu-results Key Takeaways

  • EyePoint will reduce its workforce by approximately 53%, targeting $30 million in annualized savings

  • Duravyu missed the primary endpoint in both phase 3 wet AMD trials, prompting early termination of the studies

  • The company will prioritize its phase 3 DME program, with results expected in Q4 2027

EyePoint announced plans to reduce its workforce by approximately 53% and end its phase 3 wet age-related macular degeneration (AMD) trials early after its investigational therapy Duravyu (vorolanib intravitreal insert) failed to meet the primary endpoint in a second pivotal phase 3 study.

The restructuring, announced on Monday, is expected to generate approximately $30 million in annualized savings as the company shifts resources toward its late-stage Duravyu program in diabetic macular edema (DME).

The decision follows topline results from the phase 3 LUCIA trial, in which Duravyu failed to demonstrate statistical noninferiority to aflibercept in mean change in best-corrected visual acuity (BCVA), despite improvements in vision. The earlier phase 3 LUGANO trial also failed to meet its primary endpoint.

LUCIA enrolled 475 patients and LUGANO enrolled 432. Both evaluated Duravyu 2.7 mg administered every 24 weeks against aflibercept 2 mg every 8 weeks.

Despite missing their primary endpoints, both studies demonstrated reductions in treatment burden, favorable safety profiles with redosing, and sustained anatomic control through Week 56. More than 50% of Duravyu-treated patients remained free of supplemental injections through Week 56 in both trials. LUGANO demonstrated a 42% reduction in treatment burden compared with aflibercept (nominal P<.0001).

EyePoint plans to conduct additional analyses of the phase 3 datasets but will discontinue the trials before completing their second year.

The workforce reduction is expected to occur primarily during the fourth quarter of 2026 and be completed during the first half of 2027. EyePoint anticipates approximately $9 million in employee separation-related charges. The company reported approximately $118 million in cash, cash equivalents, and short-term investments as of September 30, 2026.

"Decisions involving a reduction in our workforce are exceptionally difficult, and we extend our deepest gratitude to our departing colleagues for their dedication and meaningful contributions," said Jay S. Duker, MD, president and CEO of EyePoint.

The company will now prioritize its phase 3 COMO and CAPRI trials evaluating Duravyu in DME. The studies enrolled a combined 551 patients and compare Duravyu 2.7 mg every 6 months with aflibercept every 8 weeks.

The DME program is supported by phase 2 VERONA findings, in which Duravyu met its primary endpoint of extending time to first supplemental injection. At Week 24, the 2.7-mg dose achieved a 7.1-letter BCVA gain, a 76-µm reduction in central subfield thickness, and a 73% supplement-free rate compared with 50% for aflibercept.

Topline results from COMO and CAPRI are expected in the fourth quarter of 2027.

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Second Phase 3 Trial of Duravyu in Wet AMD Misses Primary Endpoint https://eyewire.news/news/second-phase-3-trial-of-duravyu-in-wet-amd-misses-primary-endpoint Mon, 19 Oct 2026 20:05:04 GMT https://eyewire.news/news/second-phase-3-trial-of-duravyu-in-wet-amd-misses-primary-endpoint Key Takeaways

  • LUCIA did not achieve the primary endpoint of statistical noninferiority in mean change in BCVA versus on-label aflibercept (Eylea, Regeneron) control, despite demonstrating visual improvement.
  • Key secondary endpoints in LUCIA were met including a superior 38% reduction in treatment burden (nominal p-value <0.0001), with 52% of eyes supplement-free and 71% receiving zero or one supplement up to Week 56.
  • Diabetic macular edema program remains on track with phase 3 topline data anticipated in late 2027.

EyePoint announced topline results from LUCIA, the second pivotal phase 3 clinical trial of vorolanib intravitreal insert (Duravyu) for the treatment of wet AMD. In the trial, treatment with vorolanib did not achieve statistical noninferiority in mean change in BCVA versus on-label aflibercept 2 mg (Eylea, Regeneron) control, although it demonstrated visual improvement. The trial achieved key secondary endpoints including a favorable safety profile with redosing, a 38% reduction in treatment burden, a 52% supplement-free rate, 71% receiving zero or one supplement up to 56 weeks, and strong anatomic control.

EyePoint will complete additional analyses of the LUCIA and pooled phase 3 datasets to further assess next steps for DURAVYU as a potential treatment for wet AMD.

The Company continues to advance the ongoing pivotal COMO and CAPRI clinical trials for patients with diabetic macular edema (DME), with topline data expected in the fourth quarter of 2027. The phase 2 VERONA clinical trial in DME met its primary endpoint with extended time to first supplemental injection compared with aflibercept control for both doses. The trial also produced clinically meaningful outcomes, including a favorable safety profile with no vorolanib-related ocular or systemic serious adverse events (SAEs) and an early and sustained improvement in vision and anatomical control. Vorolanib 2.7 mg demonstrated a 7.1 letter BCVA gain and 76-μm central subfield thickness reduction at 24 weeks, with a supplement-free rate of 73% versus 50% for patients in the control arm.

“We are encouraged that more than 50% of Duravyu patients remained supplement-free up to 56 weeks in both phase 3 trials, providing further evidence of DURAVYU’s durability in retinal disease,” said Ramiro Ribeiro, MD, PhD, Chief Medical Officer of EyePoint. “We remain confident in the DME program, supported by Duravyu’s biologic activity through inhibition of VEGF and the IL-6/JAK1 pathway, its continued favorable safety profile, and the early visual and anatomic improvements observed in VERONA.”

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FDA Approves Ryzumvi for the Treatment of Presbyopia https://eyewire.news/news/fda-approves-ryzumvi-for-the-treatment-of-presbyopia Mon, 19 Oct 2026 18:51:48 GMT https://eyewire.news/news/fda-approves-ryzumvi-for-the-treatment-of-presbyopia Key Takeaways

  • The FDA approved Ryzumvi (phentolamine ophthalmic solution 0.75%) for presbyopia in adults

  • Phase 3 VEGA-2 and VEGA-3 trials met primary and key secondary efficacy endpoints, with no treatment-related serious adverse events

  • Viatris holds exclusive US commercialization rights

The FDA has approved Opus Genetics' supplemental new drug application (NDA) for Ryzumvi (phentolamine ophthalmic solution 0.75%) for the treatment of presbyopia in adults, expanding the drug's existing indication for reversal of pharmacologically induced mydriasis.

The approval provides an additional noninvasive pharmacologic treatment option for presbyopia. Ryzumvi is a preservative-free, topical ophthalmic formulation designed to modulate pupil dynamics through a sympatholytic mechanism of action. By avoiding engagement of the ciliary muscle, the therapy aims to improve visual acuity while maintaining distance vision.

The approval was supported by results from the pivotal phase 3 VEGA-2 and VEGA-3 clinical trials. Both studies met their primary and all key secondary efficacy endpoints, with no treatment-related serious adverse events reported.

“This approval marks an important milestone for Opus Genetics, representing our second US drug approval and underscoring our clinical and regulatory capabilities,” said George Magrath, MD, CEO of Opus Genetics.

Opus Genetics has a global licensing agreement with Viatris, through an affiliated entity, covering the development of phentolamine ophthalmic solution 0.75%. Under the agreement, Viatris holds exclusive US commercialization rights.

The expanded FDA approval will trigger a milestone payment to Opus Genetics, although the company did not disclose the payment amount.

Ryzumvi is already marketed in the United States for the reversal of pharmacologically induced mydriasis. The new indication broadens its potential clinical use to adults with presbyopia, which affects approximately 90% of US adults older than 45, according to the company.

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SpyGlass Pharma Announces Positive 4-Year Data for BIM-IOL System https://eyewire.news/news/spyglass-pharma-announces-positive-4-year-data-for-bim-iol-system Mon, 19 Oct 2026 16:59:11 GMT https://eyewire.news/news/spyglass-pharma-announces-positive-4-year-data-for-bim-iol-system SpyGlass Pharma announced positive 4-year first-in-human (FIH) trial results for the Bimatoprost Drug Pad-IOL (BIM-IOL) System in patients with mild-to-moderate open angle glaucoma or ocular hypertension undergoing routine cataract surgery. SpyGlass Pharma designed the FIH trial to evaluate the safety and efficacy of the BIM-IOL System for 7 years.

Interim safety and efficacy data in evaluable patients (n = 21) at the 4-year timepoint demonstrated:

  • 37% reduction in mean IOP across all three dose groups from 25.1 ± 2.5 mm Hg at baseline post-washout to 15.9 ± 2.8 mm Hg
  • 86% (18 of 21) of patients remained off all topical IOP-lowering drops
  • 90% of patients maintained ≥ 20/25 BCDVA

In addition, no product-related adverse events were reported.

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Prevent Blindness Declares October 19-25 as Annual Inflammatory Eye Disease Week https://eyewire.news/news/prevent-blindness-declares-october-19-25-as-annual-inflammatory-eye-disease-week Mon, 19 Oct 2026 16:03:34 GMT https://eyewire.news/news/prevent-blindness-declares-october-19-25-as-annual-inflammatory-eye-disease-week Prevent Blindness declared its sixth annual inflammatory eye disease (IED) week as October 19 to 25, 2026. In a study published last year in Ophthalmology, IEDs were found to account for 10% to 15% percent of legal blindness in the United States.1 Additionally, the working-age population is disproportionately affected.

To provide patients, care partners, and health care allies with educational resources on IEDs, Prevent Blindness offers a dedicated webpage, shareable social media graphics, downloadable fact sheets in English and Spanish, and multiple expert- and patient-testimonial videos. This year, Prevent Blindness recognizes Keenova Therapeutics as its gold sponsor for IED week. New this year, Prevent Blindness has created the educational video, “Uveitis: A Closer Look.” This resource includes easy-to-understand information on uveitis, including causes, symptoms, treatment options, and more.

For more information on inflammatory eye disease, please visit preventblindness.org/inflammatory-eye-disease. For a listing of vision care financial assistance programs in English or Spanish, visit preventblindness.org/vision-care-financial-assistance-information.

1. Hunt MS, McKay KM, Lee AY, Lee CS, Van Gelder RN; IRIS Registry Analytic Center Consortium. Burden of noninfectious ocular inflammatory disease in United States ophthalmology practice. Ophthalmology. 2025;132(10):1182-1184. doi.org/10.1016/j.ophtha.2025.05.018

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FDA Approves Alcon’s Brytly Redness Reliever Eye Drops https://eyewire.news/news/fda-approves-alcons-brytly-redness-reliever-eye-drops Mon, 19 Oct 2026 14:49:11 GMT https://eyewire.news/news/fda-approves-alcons-brytly-redness-reliever-eye-drops Alcon announced that the FDA approved its Brytly Redness Reliever Eye Drops. With one drop, Brytly works in 1 minute to significantly reduce redness and deliver up to 12 hours of whiter, brighter-looking eyes. The approval brings a new option to the OTC redness-relief category and expands Alcon’s portfolio of consumer eye care products.

“When patients ask about eye whiteners, they want a product they can trust to work effectively and fit into their day,” said Selina McGee, OD, FAAO, founder and chief optometrist of Bespoke Vision in Edmond, Oklahoma, in a press release.1 “Brytly gives eye care professionals a clinically proven option to recommend, with demonstrated safety and efficacy and long-lasting redness reduction from a single drop.”

The drop is expected to be available at major retailers nationwide and online in the coming months, and in additional markets in the future.

1. FDA approves Alcon’s Brytly Redness Reliever Eye Drops for up to 12 hours of whiter, brighter-looking eyes [press release]. Alcon. October 16, 2026. Accessed October 19, 2026. www.alcon.com/media-release/fda-approves-alcons-brytly-redness-reliever-eye-drops-12-hours-whiter-brighter/

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Oculis Completes Randomization for its Phase 2 Trial of Licaminlimab https://eyewire.news/news/oculis-completes-randomization-for-its-phase-2-trial-of-licaminlimab Mon, 19 Oct 2026 14:30:31 GMT https://eyewire.news/news/oculis-completes-randomization-for-its-phase-2-trial-of-licaminlimab Key Takeaways

  • Oculis completed randomization of its PREDICT-1 clinical trial of licaminlimab for the treatment of dry eye disease.
  • The PREDICT-1 trial will evaluate the efficacy of licaminlimab in patients with and without the tumor necrosis factor receptor 1 geneotype.
  • In a previous study, patients treated with licaminlimab experienced a statistically significant reduction in ocular discomfort compared with vehicle at day 29.

Oculis announced completion of randomization in the phase 2 PREDICT-1 clinical trial of licaminlimab, the first genotype-based registrational trial in dry eye disease (DED). The company expects to report topline results around the end of 2026.

PREDICT‑1 is designed to evaluate the efficacy of licaminlimab in treating symptoms of DED compared with a vehicle in patients carrying a specific tumor necrosis factor receptor 1 (TNFR1) genotype, while also assessing its effectiveness and safety in the overall study population. A total of 176 patients have been enrolled in this randomized, multicenter, double-masked, vehicle-controlled study, two-thirds of whom have the specified TNFR1 genotype. The primary endpoint is change from baseline at day 29 in the global ocular discomfort severity score in patients with the specified TNFR1 genotype. The same outcome measure will also be evaluated in the overall study population as a key secondary endpoint.

In a previous phase 2 trial, patients treated with licaminlimab experienced a statistically significant reduction in ocular discomfort compared with vehicle at day 29, with a rapid onset of action observed as early as day 14.5.

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Alvotech and Advanz Pharma Submit European Application for First Proposed Eylea 8 mg Biosimilar https://eyewire.news/news/alvotech-and-advanz-pharma-submit-european-application-for-first-proposed-eylea-8-mg-biosimilar Fri, 16 Oct 2026 14:47:54 GMT https://eyewire.news/news/alvotech-and-advanz-pharma-submit-european-application-for-first-proposed-eylea-8-mg-biosimilar Key Takeaways

  • Alvotech and Advanz Pharma submitted a European application for AVT29, reportedly the first proposed biosimilar to Eylea 8 mg to reach regulatory submission

  • The high-dose aflibercept formulation supports treatment intervals of up to 16 weeks for certain patients, potentially reducing injection burden

  • AVT29 was submitted as a line extension to Mynzepli, the companies' European-approved biosimilar to Eylea 2 mg

Alvotech and Advanz Pharma have submitted a European regulatory application for AVT29, a proposed biosimilar to Eylea 8 mg (aflibercept 114.3 mg/mL), marketed as Eylea HD in the United States.

According to the companies, the application represents the first regulatory submission worldwide for a proposed biosimilar to the high-dose aflibercept formulation, based on publicly available information. The application was submitted as a line extension to the existing European marketing authorization for Mynzepli (AVT06), Alvotech's biosimilar to Eylea 2 mg (aflibercept 40 mg/mL).

Eylea 8 mg allows treatment intervals of up to 16 weeks for certain patients, compared with the standard 8-week maintenance interval associated with the original 2 mg formulation, potentially reducing injection frequency and treatment burden.

The companies highlighted the growing adoption of high-dose aflibercept. According to publicly reported financial results, Eylea 8 mg accounted for approximately 57% of combined global Eylea 2 mg and 8 mg sales by value during the second quarter of 2026, compared with approximately 30% during the corresponding period in 2025.

Mynzepli received European Commission approval in August 2025 in vial and prefilled syringe presentations for the treatment of various retinal diseases.

Under the companies' partnership agreement, Alvotech is responsible for developing and supplying AVT06 and AVT29, while Advanz Pharma oversees European registration and commercialization. Advanz Pharma holds exclusive commercialization rights throughout Europe, except in Germany and France, where rights are semi-exclusive.

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International Eye Health Organizations Call for Global Support of St John's Compact Ahead of 2026 Summit https://eyewire.news/news/international-eye-health-organizations-call-for-global-support-of-st-johns-compact-ahead-of-2026-summit Fri, 16 Oct 2026 14:05:52 GMT https://eyewire.news/news/international-eye-health-organizations-call-for-global-support-of-st-johns-compact-ahead-of-2026-summit Key Takeaways

  • Fourteen eye health and development organizations are calling for broader endorsement of the St John's Global Compact for Eye Health

  • More than 100 countries and organizations have endorsed the voluntary agreement, with additional endorsements encouraged by November 1, 2026.

  • The Compact will guide discussions at the inaugural Global Summit for Eye Health in Antigua and Barbuda in November 2026

Fourteen eye health and development organizations have issued a joint call for partners across the eye care sector to endorse the St John's Global Compact for Eye Health, an international agreement aimed at accelerating progress toward eliminating avoidable vision loss.

The Compact establishes a shared framework for governments, civil society organizations, private sector partners, and international institutions to coordinate efforts to expand access to quality eye care services worldwide.

More than 100 countries and organizations have already endorsed the agreement, according to the announcement. Additional eye care and development organizations are encouraged to sign before the November 1, 2026, deadline.

The Compact will serve as a central framework for the inaugural Global Summit for Eye Health, scheduled for November 2026 in Antigua and Barbuda. The summit will bring together government representatives, development partners, healthcare leaders, and advocates to advance coordinated strategies for improving access to eye care.

Although the Compact is voluntary and nonbinding, endorsement signals an organization's commitment to strengthening eye health systems and advancing eye care as a global development priority. Most of the 14 organizations issuing the joint statement are also High Impact Partners supporting the upcoming summit.

"We already have the evidence, innovation and partnerships needed to end avoidable sight loss. What we need now is greater collective commitment and coordinated action," said Jessica Thompson, deputy CEO of the International Agency for the Prevention of Blindness (IAPB).

Ms. Thompson emphasized that broader participation would strengthen international efforts to address preventable vision impairment and improve access to essential eye care.

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FDA Approves Genentech's Enspryng as First At-Home Subcutaneous Treatment for Thyroid Eye Disease https://eyewire.news/news/fda-approves-genentechs-enspryng-as-first-at-home-subcutaneous-treatment-for-thyroid-eye-disease Fri, 16 Oct 2026 12:49:23 GMT https://eyewire.news/news/fda-approves-genentechs-enspryng-as-first-at-home-subcutaneous-treatment-for-thyroid-eye-disease Key Takeaways

  • The FDA approved Enspryng as the first at-home subcutaneous treatment for adults with thyroid eye disease

  • The approval follows a priority review and is supported by results from the phase 3 SatraGO clinical program, which demonstrated improvements in proptosis and diplopia

  • No new safety signals were identified, and at-home administration may reduce treatment burden

The FDA has approved Genentech’s Enspryng (satralizumab-mwge) for the treatment of adults with thyroid eye disease (TED), making it the first and only subcutaneous treatment for the condition that can be administered at home.

According to the company, patients or caregivers can administer Enspryng following training by a healthcare provider, offering an alternative to infusion-based treatment. 

“Treating thyroid eye disease requires balancing efficacy, safety, and the practical realities of long-term treatment,” said César A. Briceño, MD, Clinical Trial Investigator and Associate Professor of Ophthalmology at the Scheie Eye Institute, University of Pennsylvania. “As a clinical trial investigator, I have seen firsthand the potential of targeted therapies such as Enspryng. The availability of an effective subcutaneous treatment option could provide greater flexibility for both patients and physicians while reducing the logistical burden associated with infusion-based therapies. Enspryng has the potential to meaningfully expand our therapeutic options for patients with thyroid eye disease.”

The approval follows a priority review and is supported by results from the phase 3 SatraGO clinical program, comprising of SatraGO-1 (NCT05987423) and SatraGO-2 (NCT06106828). The randomized, placebo-controlled, multicenter studies enrolled 258 patients across 19 countries, including adults with active, moderate-to-severe TED and chronic TED. The primary endpoint was the proportion of patients with active TED achieving a reduction in proptosis of at least 2 mm in the study eye at week 24.

Although SatraGO-1 did not meet its prespecified primary efficacy endpoint, SatraGO-2 demonstrated significant improvements in proptosis and diplopia among patients with active TED.

In SatraGO-2, 52.9% of patients receiving Enspryng achieved a proptosis response compared with 23.4% receiving placebo. Diplopia reduction was reported in 60.7% of patients treated with Enspryng versus 25.8% in the placebo group.

According to Genentech, consistent efficacy results were observed in the overall SatraGO-2 population, which included patients with active and chronic TED.

No new safety signals were identified in either study, and the safety profile remained consistent with previous experience in neuromyelitis optica spectrum disorder (NMOSD).

The approval represents Enspryng’s second FDA-approved indication, following its 2020 approval for neuromyelitis optica spectrum disorder (NMOSD). This follows a recent acceptance by the FDA for priority review in myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). Enspryng is also being studied in additional neurological autoimmune and inflammatory diseases that may benefit from inhibition of IL-6 mediated signaling. The therapy targets interleukin-6 receptor signaling and is also under investigation for other autoimmune and inflammatory conditions.

Enspryng is third pharmocologic treatment approved for TED, joining Horizon Therapeutics' Tepezza (teprotumumab-trbw), which was approved in 2020, and Viridian Therapeutics' Lumvoa (veligrotug-vvze), which was approved in June of this year. 

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Study Finds Rising Demand for Emergency Ophthalmology Consultations Across US Academic Centers https://eyewire.news/news/study-finds-rising-demand-for-emergency-ophthalmology-consultations-across-us-academic-centers Thu, 15 Oct 2026 14:43:08 GMT https://eyewire.news/news/study-finds-rising-demand-for-emergency-ophthalmology-consultations-across-us-academic-centers Key Takeaways

  • Ophthalmology transfer requests and hospital consultations increased significantly across US academic medical centers from 2013 to 2024

  • Findings highlight increasing pressure on hospital-based ophthalmology coverage and the need for workforce planning

Demand for hospital-based ophthalmic care has increased significantly across US academic medical centers, according to a retrospective multicenter study published October 1, 2026, in JAMA Network Open.1

The study, led by Shu Feng, MD, and colleagues, analyzed trends in interhospital ophthalmology transfers and emergency department (ED) and inpatient consultations at 14 hospitals affiliated with 10 academic medical centers between 2013 and 2024. Researchers examined 32,131 ophthalmology transfer requests, 23,560 accepted transfers, and 139,356 ophthalmology consultations across participating institutions.

Transfer requests increased by an aggregate 0.66 per 100,000 state residents annually, while accepted transfers increased by 0.34 per 100,000 residents annually.

Among 7 institutions with consultation data, ophthalmology consultations increased by 3.01 per 100,000 state residents annually. ED consultations increased by 2.06 per 100,000 residents per year, while inpatient consultations increased by 1.08 per 100,000 residents annually.

All aggregate trends were statistically significant after adjustment for multiple comparisons (P<.001).

The findings suggest that academic medical centers are facing growing demand for urgent and complex ophthalmic services, potentially increasing pressure on ophthalmologists providing hospital-based coverage.

The investigators noted that academic hospitals frequently serve as referral centers for patients requiring specialized ophthalmic evaluation and treatment. Increasing transfer and consultation volumes may therefore have implications for staffing, resident coverage, and the organization of emergency ophthalmic services.

The study was limited to participating academic institutions, which may affect the generalizability of its findings to community hospitals and other practice settings. The authors concluded that rising demand for ophthalmic hospital services warrants attention to workforce sustainability and health system planning to maintain access to timely specialty care.

Reference

1. Feng S, et al. Trends in Ophthalmic Hospital Transfers and Consultations Across US Academic Centers. JAMA Network Open. 2026;9(10):e2640040. doi:10.1001/jamanetworkopen.2026.40040

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Raytracing-Guided LASIK Improves Visual Outcomes in Patients Dissatisfied after Cataract Surgery https://eyewire.news/news/raytracing-guided-lasik-improves-visual-outcomes-in-patients-dissatisfied-after-cataract-surgery Thu, 15 Oct 2026 14:11:50 GMT https://eyewire.news/news/raytracing-guided-lasik-improves-visual-outcomes-in-patients-dissatisfied-after-cataract-surgery Key Takeaways

  • Raytracing-guided LASIK reduced higher-order aberrations approximately 70% in 55 pseudophakic eyes

  • Visual acuity, residual astigmatism, and mesopic contrast sensitivity improved at 3 months.

Raytracing-guided LASIK enhancement using Alcon's Wavelight Plus diagnostic and treatment platform significantly reduced higher-order aberrations and improved visual acuity in patients with residual visual complaints following cataract surgery, according to research presented at the 130th annual meeting of the American Academy of Ophthalmology (AAO).

The study, led by A. John Kanellopoulos, MD, evaluated 55 pseudophakic eyes implanted with monofocal toric, extended depth-of-focus, or trifocal IOLs. All eyes underwent raytracing-guided LASIK enhancement using the WaveLight Plus.

At 3 months, mean uncorrected distance visual acuity improved from 20/23 to 20/16, while best-corrected visual acuity improved from 20/16 to 20/12. Residual astigmatism decreased from −0.85 D to −0.25 D. Higher-order aberrations declined approximately 70%, from 1.55 μm preoperatively to 0.45 μm postoperatively. Mesopic contrast sensitivity also improved by 1 to 7 steps across spatial frequencies.

"We are seeing a growing group of patients who have had technically excellent cataract surgery, often with premium implants, and who are nevertheless unhappy with their vision," said A. John Kanellopoulos, MD, who led the research. Many, he said, have "optical complaints that do not show up on a standard eye chart at all."

According to the investigators, subtle IOL tilt or decentration relative to the cornea and visual axis may contribute to optical aberrations that conventional refractive measurements do not adequately capture. Unlike traditional corneal topography—or wavefront-guided treatments, raytracing models the eye's complete optical system to calculate a customized laser correction.

The researchers noted that using the platform in pseudophakic eyes is off-label, as the technology was developed and approved for eyes without prior surgery.

Dr. Kanellopoulos suggested that raytracing-guided enhancement could provide a less invasive alternative to IOL exchange in appropriately selected patients.

Investigators plan additional prospective research comparing raytracing-guided treatment with conventional laser enhancement and evaluating longer-term outcomes and patient-reported visual quality.

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Eclipse Life Sciences Reports Positive Phase 2 Results for EC-104 in DME https://eyewire.news/news/eclipse-life-sciences-reports-positive-phase-2-results-for-ec-104-in-dme Thu, 15 Oct 2026 13:55:22 GMT https://eyewire.news/news/eclipse-life-sciences-reports-positive-phase-2-results-for-ec-104-in-dme Key Takeaways

  • BETTIS-1 met its primary safety endpoint, with no unexpected safety signals reported for EC-104

  • EC-104 demonstrated sustained visual and anatomical improvements through 24 weeks compared with Ozurdex

  • Eclipse Life Sciences anticipates initiating phase 3 development in 2027

Eclipse Life Sciences announced positive topline results from its phase 2 BETTIS-1 clinical trial evaluating EC-104, a biodegradable intravitreal fluocinolone acetonide implant, for the treatment of diabetic macular edema (DME).

The trial met its primary endpoint, demonstrating a favorable safety profile for both EC-104 formulations compared with Ozurdex (dexamethasone intravitreal implant). According to the company, secondary endpoints showed superior, clinically meaningful improvements in best-corrected visual acuity (BCVA) and optical coherence tomography (OCT) central subfield thickness (CST) at 24 weeks compared with Ozurdex.

EC-104 is designed to provide approximately 6 months of sustained corticosteroid delivery. The BETTIS-1 study evaluated patients with a history of suboptimal response to anti-VEGF therapy, a population with limited treatment options.

Both EC-104 formulation groups demonstrated sustained reductions in CST through 24 weeks. The company also reported low rates of treatment-related adverse events, no unexpected safety signals, and acceptable intraocular pressure outcomes among patients with prior corticosteroid tolerance.

“These results position EC-104 as a highly competitive candidate in the DME landscape,” said Scott Cousins, MD, CEO and vice president of research and development at Eclipse Life Sciences. “The 6-month durability, consistent anatomical response, and strong safety profile reinforce EC-104’s potential to meaningfully reduce treatment burden.”

The company did not provide numerical efficacy results, adverse event rates, or statistical comparisons in its topline announcement.

Eclipse Life Sciences plans to engage regulatory authorities regarding phase 3 development and expects to initiate a pivotal clinical program in 2027. The company is also exploring strategic partnerships to support late-stage development and commercialization.

Full BETTIS-1 results are expected to be presented at an upcoming ophthalmology conference and submitted for peer-reviewed publication.

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European Trial Finds PRIMA Retinal Implant Demonstrates Sustained Vision Improvement at 3 Years in GA https://eyewire.news/news/european-trial-finds-prima-retinal-implant-demonstrates-sustained-vision-improvement-at-3-years-in-ga Wed, 14 Oct 2026 12:57:59 GMT https://eyewire.news/news/european-trial-finds-prima-retinal-implant-demonstrates-sustained-vision-improvement-at-3-years-in-ga Key Takeaways

  • PRIMA implantation was associated with sustained visual acuity improvement from approximately 20/460 to 20/120 at 36 months

  • Among 18 patients evaluated at 3 years, 78% achieved gains of at least 3 lines of visual acuity

Three-year results from the PRIMAvera clinical trial suggest that the PRIMA retinal implant (Science Corporation) can provide sustained improvements in functional vision among patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

The findings, presented at the 130th annual meeting of the American Academy of Ophthalmology (AAO), showed that patients maintained clinically meaningful visual acuity improvements through 36 months following implantation.

The multicenter study enrolled 38 patients across 17 European centers. The PRIMA system consists of a wireless photovoltaic chip implanted beneath the retina and camera-equipped glasses that project infrared light onto the implant. The chip converts the light into electrical signals that stimulate surviving retinal neurons.

At baseline, mean visual acuity was approximately 20/460. Among 18 patients evaluated at 36 months, mean visual acuity with the device improved to approximately 20/120, representing a gain of nearly 6 lines on a standard eye chart.

Additionally, 78% of patients (14 of 18) achieved improvements of at least 2 lines, with the same proportion gaining at least 3 lines.

"We were very gratified to see that the remarkable gains we found at 12 months persisted through 36 months," said Joseph Martel, MD, the study's lead author.

Investigators also reported that residual vision in implanted eyes remained largely stable with the device switched off, while vision in untreated fellow eyes continued to decline.

Most serious adverse events occurred during the first postoperative year and were associated with surgery. Between months 13 and 36, 3 patients experienced 1 serious ocular adverse event each. 

Developed by Science Corporation, PRIMA received CE marking in July 2026, permitting commercialization in Europe. The device has not received US regulatory approval.

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Cosmetic Products Linked to More than 42,000 Eye Injuries Over 20 Years, Study Finds https://eyewire.news/news/cosmetic-products-linked-to-more-than-42000-eye-injuries-over-20-years-study-finds Wed, 14 Oct 2026 12:52:16 GMT https://eyewire.news/news/cosmetic-products-linked-to-more-than-42000-eye-injuries-over-20-years-study-finds Key Takeaways

  • Cosmetic and personal care products were associated with an estimated 42,457 emergency department visits for ocular injuries from 2005 to 2024

  • Young children faced disproportionate risks from chemical burns, with unsupervised access contributing to many injuries

  • Prevention strategies should emphasize safe product storage for children and careful handling of heated cosmetic devices among older patients

Cosmetic and personal care products were associated with an estimated 42,457 eye injuries requiring emergency department visits in the United States between 2005 and 2024, according to research presented at the 130th annual meeting of the American Academy of Ophthalmology (AAO).

The findings represent approximately 2,100 emergency department visits annually and highlight age-related differences in injury mechanisms that could inform prevention strategies.

Led by Aatif Syed, a medical student at the University of Missouri-Kansas City, researchers analyzed data from the National Electronic Injury Surveillance System to estimate the national burden of cosmetic-related ocular injuries.

Women and girls accounted for 81.8% of injuries, and the mean patient age was 24 years. Children aged 4 years and younger represented nearly one-quarter of cases, while 63% of injuries occurred at home. Thermal burns accounted for approximately 26% of injuries, followed by chemical exposures at approximately 25%.

The analysis identified substantial differences between pediatric and adult patients. Chemical burns represented 45.8% of injuries among younger patients compared with 0.5% among adults. Children accounted for 83.2% of all chemical burns, and 70% of injuries among children aged 4 years and younger involved unsupervised access to cosmetic products.

Among adults, 90% of injuries occurred during self-application rather than professional cosmetic services.

Researchers also observed a decline in injuries involving heated products over the study period, while injuries involving another person increased.

“Cosmetic products may seem relatively low risk because they are everyday household items, but when they contact the eye, particularly chemicals or very hot devices, they can cause significant injury,” Mr. Syed said.

The findings underscore the importance of age-specific prevention efforts, including secure storage of cosmetics and sprays around young children and safer handling of heated styling devices and grooming instruments among adolescents and adults.

The AAO provides additional patient education on safe cosmetic use around the eyes through its online eye makeup safety guide.

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Euclid Vision Launches My Euclid Platform to Streamline Orthokeratology Fitting and Ordering https://eyewire.news/news/euclid-vision-launches-my-euclid-platform-to-streamline-orthokeratology-fitting-and-ordering Wed, 14 Oct 2026 12:36:57 GMT https://eyewire.news/news/euclid-vision-launches-my-euclid-platform-to-streamline-orthokeratology-fitting-and-ordering Key Takeaways

  • My Euclid integrates Ortho-K lens fitting, ordering, patient management, and consultation support into one cloud-based platform

  • CloudLink enables direct integration with compatible corneal topography systems to support individualized lens fitting

Euclid Vision announced the launch of My Euclid, a cloud-based platform designed to streamline orthokeratology (Ortho-K) lens fitting, ordering, and patient management for eye care practitioners.

The platform integrates corneal topography data, lens fitting tools, order tracking, and consultation support into a centralized workflow. Practitioners can use Euclid’s three-factor fitting approach or incorporate patient-specific corneal topography data to guide lens selection.

My Euclid is designed for practitioners with varying levels of Ortho-K experience, including those beginning to offer orthokeratology and experienced fitters seeking greater efficiency in managing patients and lens orders. Through its CloudLink plug-in, the platform connects with compatible corneal topography systems, allowing practitioners to upload selected topography data directly into the fitting and ordering workflow, according to a company news release.

Currently supported systems include the Medmont Meridia family and E300 topographers, CSO topographers using Phoenix software, Keratron Scout, Oculus Keratograph, and Oculus Pentacam. The platform can also accommodate data from other topography instruments, with additional direct integrations in development.

According to Euclid, the platform is intended to reduce manual calculations and data entry, improve communication and order tracking, and support greater consistency throughout the fitting process.

The system also maintains clinical consultation oversight. Every lens order submitted through My Euclid is reviewed by the Euclid Consultation Team before manufacturing.

“As Ortho-K continues to play an important role in proactive myopia management, practitioners need technology that fits naturally into the way they care for patients,” said Kip Crecca, senior vice president of Commercial Americas at Euclid.

My Euclid is available at no additional cost to Euclid customers. Practitioners can access a demonstration through the company's website or learn more at Vision by Design in October 2026.

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ANI Pharmaceuticals Reports Sustained 24-Month Efficacy of Iluvien in Phase 4 SYNCHRONICITY Trial https://eyewire.news/news/ani-pharmaceuticals-reports-sustained-24-month-efficacy-of-iluvien-in-phase-4-synchronicity-trial Mon, 12 Oct 2026 15:28:52 GMT https://eyewire.news/news/ani-pharmaceuticals-reports-sustained-24-month-efficacy-of-iluvien-in-phase-4-synchronicity-trial Key Takeaways

  • SYNCHRONICITY met both co-primary endpoints at 6 months, with improvements in BCVA and CST maintained through 24 months

  • Nearly 80% of study eyes remained free of inflammatory recurrence over 24 months following a single implant

  • Safety findings were consistent with previous trials, with IOP elevation and cataract-related complications remaining important considerations

ANI Pharmaceuticals announced 6-month and 24-month results from its Phase 4 SYNCHRONICITY trial evaluating the fluocinolone acetonide intravitreal implant (Iluvien) in patients with chronic noninfectious uveitis affecting the posterior segment (NIU-PS).

The findings were presented by David R.P. Almeida, MD, MBA, PhD, principal investigator of SYNCHRONICITY, during Uveitis Subspecialty Day at the American Academy of Ophthalmology (AAO) 2026 Annual Meeting in New Orleans.

The open-label, single-arm trial enrolled 108 patients and met both co-primary endpoints at month 6. Mean best-corrected visual acuity (BCVA) improved by 3.6 ETDRS letters (P=.0077), while mean central subfield thickness (CST) decreased by 157.5 µm (P<.0001).

At month 24, improvements were generally maintained, with mean BCVA increasing by 5.5 letters and mean CST decreasing by 171.2 µm from baseline.

Over the 24-month study period, 79.6% of study eyes (86/108) experienced no recurrence of noninfectious inflammation. Among eyes with recurrence, median time to recurrence was 168 days. At month 24, macular edema resolution was observed in 48.2% of study eyes, while vascular leakage decreased from 78.7% at baseline to 55.6%.

Safety findings were consistent with previous studies of the implant. Treatment-related adverse events occurred in 29% of patients, most commonly ocular hypertension (6%), cataract (5%), and reduced visual acuity (5%).

Intraocular pressure (IOP) reached at least 25 mmHg in 17.6% of patients, and 29.6% required IOP-lowering medication. Additionally, 7.4% underwent laser or surgical IOP-lowering intervention, and 14.8% underwent cataract surgery.

"SYNCHRONICITY followed patients with chronic NIU-PS for 2 years after a single implant. CST and visual acuity were improved at month 6 and remained improved at month 24, with a safety profile consistent with prior trials," Dr. Almeida said.

The findings provide additional long-term evidence regarding the efficacy and safety of fluocinolone acetonide intravitreal implantation in steroid-responsive patients with chronic NIU-PS.

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Merck’s Remigromig Meets Primary Endpoint in Phase 2b/3 BRUNELLO Trial for DME https://eyewire.news/news/mercks-remigromig-meets-primary-endpoint-in-phase-2b3-brunello-trial-for-dme Mon, 12 Oct 2026 15:14:30 GMT https://eyewire.news/news/mercks-remigromig-meets-primary-endpoint-in-phase-2b3-brunello-trial-for-dme Key Takeaways

  • Both remigromig doses achieved noninferior BCVA gains compared with monthly ranibizumab at 1 year in the pivotal BRUNELLO trial

  • PDR-related adverse events and treatment discontinuations were more frequent with remigromig, warranting further safety evaluation

  • Remigromig targets the Wnt pathway, offering a potential alternative mechanism for DME treatment, with additional pivotal data anticipated from BAROLO

Merck announced 1-year results from the pivotal phase 2b/3 BRUNELLO trial evaluating remigromig (MK-3000), an investigational Wnt pathway agonist for diabetic macular edema (DME). Findings were presented at the American Academy of Ophthalmology (AAO) 2026 annual meeting in New Orleans.

Both remigromig doses met the primary endpoint of noninferiority to monthly ranibizumab 0.5 mg in mean change from baseline in best-corrected visual acuity (BCVA) at week 52. Mean BCVA gains were 9.1 letters with remigromig 0.5 mg and 8.7 letters with remigromig 0.8 mg, compared with 11.8 letters for ranibizumab. Neither remigromig dose demonstrated superiority on secondary endpoints.

Safety findings identified higher rates of proliferative diabetic retinopathy (PDR)-related adverse events with remigromig. These occurred in 6.7% and 6.1% of patients receiving remigromig 0.5 mg and 0.8 mg, respectively, compared with 0.9% receiving ranibizumab. Treatment discontinuations due to adverse events were also higher with remigromig (4.9% and 4.5% versus 0.9%).

Merck reported that PDR cases were generally manageable with standard treatment and that additional safety analyses are ongoing.

Remigromig is a tetravalent, tri-specific antibody designed to activate the Wnt pathway, which contributes to blood-retinal barrier maintenance and repair. Its mechanism differs from anti-VEGF therapies that directly inhibit vascular endothelial growth factor.

The randomized, double-masked BRUNELLO trial enrolled 984 adults with DME who received monthly intravitreal injections during the first year. Treatment frequency will transition to personalized intervals during the second year.

Merck plans to discuss the findings with regulatory authorities. Remigromig is also being evaluated in the pivotal phase 2b/3 BAROLO trial for DME and the phase 2 SUPER TUSCAN study for wet age-related macular degeneration and retinal vein occlusion.

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Stoke Therapeutics Presents STK-002 Data for Autosomal Dominant Optic Atrophy at AAO https://eyewire.news/news/stoke-therapeutics-presents-stk-002-data-for-autosomal-dominant-optic-atrophy-at-aao Mon, 12 Oct 2026 15:04:36 GMT https://eyewire.news/news/stoke-therapeutics-presents-stk-002-data-for-autosomal-dominant-optic-atrophy-at-aao Key Takeaways

  • STK-002 is an investigational RNA-based therapy designed to increase OPA1 protein expression in patients with autosomal dominant optic atrophy

  • Natural history and preclinical findings support its therapeutic rationale, including improvements in mitochondrial function observed in patient-derived cells

  • The phase 1 OSPREY trial has completed its first 2 dose cohorts, with initial safety and efficacy results from higher-dose cohorts expected in the first half of 2027

Stoke Therapeutics presented new preclinical and natural history data supporting the development of STK-002, an investigational RNA-based therapy for autosomal dominant optic atrophy (ADOA), at the American Academy of Ophthalmology (AAO) 2026 annual meeting in New Orleans.

The presentations highlighted findings from the FALCON natural history study and preclinical research supporting the ongoing phase 1 OSPREY trial, which is evaluating STK-002 in patients with OPA1-associated ADOA.

ADOA is the most common inherited optic nerve disorder and is primarily associated with variants in the OPA1 gene. These variants can reduce functional OPA1 protein expression by approximately 50%, contributing to mitochondrial dysfunction, retinal ganglion cell degeneration, and progressive vision loss.

Results from FALCON demonstrated increased mitochondrial oxidative stress in patients with ADOA compared with healthy individuals. Higher oxidative stress levels were strongly correlated with reduced visual acuity, supporting the rationale for therapies targeting OPA1 protein deficiency.

STK-002 is designed to increase functional messenger RNA production from the unaffected copy of the OPA1 gene, potentially restoring OPA1 protein expression.

In preclinical studies, STK-002 demonstrated dose-dependent increases in retinal exposure, target engagement, and OPA1 protein expression. Treatment also improved mitochondrial function in patient-derived cells carrying different OPA1 variants. The first 2 dose cohorts in the Phase 1 OSPREY study have completed dosing. The third cohort is expected to complete dosing by the end of 2026, with a fourth cohort planned pending safety assessments.

According to Stoke, the third and fourth cohorts may reach therapeutically relevant dose levels, with initial safety and efficacy data anticipated in the first half of 2027.

"These early data are an important step in evaluating whether an RNA-based medicine can address the underlying OPA1 deficiency and ultimately improve visual outcomes for people with ADOA," said Patrick Yu-Wai-Man, MD, PhD, lead investigator of OSPREY.

No treatments are currently approved for ADOA.

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American Academy of Ophthalmology Announces 2026 Award Recipients at Annual Conference https://eyewire.news/news/american-academy-of-ophthalmology-announces-2026-award-recipients-at-annual-conference Mon, 12 Oct 2026 14:58:50 GMT https://eyewire.news/news/american-academy-of-ophthalmology-announces-2026-award-recipients-at-annual-conference From honorary lectures to annual awards, the following organizations and individuals received special recognition at the American Academy of Ophthalmology’s 130th annual meeting:

HONORED ON THURSDAY, OCT 8

During the Fall Council Meeting, Mary Louise Z. Collins, MD, was presented with the Hall of Fame Award for her career-long commitment to state advocacy. The Hall of Fame award is selected by the Academy Secretariat for State Affairs. 

HONORED ON FRIDAY, OCT 9

Academy President Christopher J. Rapuano, MD, named Richard L. Abbott, MD, Dale E. Fajardo, EdD, MBA, Peter R. Laibson, MD, and Gregory L. Skuta, MD, as his AAO 2026 Guests of Honor.

Robert W. Enzenauer, MD, MPH, delivered the Leonard Apt Lecture (Kids Caught in the Combat Zone) during Pediatric Ophthalmology Subspecialty Day (Ped03; viewable on demand), which is cosponsored by the American Association for Pediatric Ophthalmology and Strabismus and the American Academy of Pediatrics (AAP). The Leonard Apt Lecture was established by the AAP Section on Ophthalmology to honor Dr. Apt, the first physician to achieve board certification in both pediatrics and ophthalmology.

Jacob A. Kanter, MD, delivered the Troutman Prize Lecture (Early Postoperative Conjunctival Complications Leading to Exposure of Surgically Implanted CorNeat EverPatch Devices) and was presented with the Troutman Prize during Refractive Surgery Subspecialty Day (Ref06; viewable on demand). The Troutman Prize recognizes the scientific merit of a young author published in the Ophthalmology family of journals.  

Carla J. Siegfried, MD, delivered the American Glaucoma Society (AGS) Subspecialty Day Lecture (Understanding Post-Vitrectomy Glaucoma: A Scientific Journey Led by Curiosity, Sparked by Serendipity) and was presented with the AGS Subspecialty Day Lectureship Award during Glaucoma Subspecialty Day (Gla05; viewable on demand).    

Richard F. Spaide, MD, delivered the Charles L. Schepens, MD, Lecture (The Joy of Seeing) during Retina Subspecialty Day (Ret05; viewable on demand).

HONORED ON SATURDAY, OCT 10

The Asia-Pacific Academy of Ophthalmology (APAO) was presented with the Distinguished Service Award during the Opening Session (Sym07; viewable on demand). The Academy recognizes APAO not only for its decades of accomplishment, but for its enduring dedication to collaboration, education, and the global mission to eliminate preventable blindness. The Academy President nominates the recipients of this award. 

George B. Bartley, MD, delivered the Dr. Allan Jensen and Claire Jensen Lecture in Professionalism and Ethics (The Many Faces of Professionalism; Sym15; viewable on demand).

Renee Bovelle, MD, was recognized as this year’s Outstanding Advocate Award recipient during the Opening Session (Sym07; viewable on demand). Bovelle was nominated by the National Medical Association, Ophthalmology Section for her sustained, high-impact advocacy at the state, regional, and national levels for more than a decade. (The Academy will start accepting nominations for the 2027 award on Dec. 1.)

Arthur Brant, MD, was recognized as this year’s Artemis Award recipient during the Opening Session (Sym07; viewable on demand). He will be presented with the award on Sunday, during the session titled YO Program Part 1—If the Shoe Fits: Choosing the Best Practice Setting for You (Sym36; 9:45-11:00 am), where he will present the Artemis Award Talk (10:25-10:35 am).

Janet Louise Davis, MD, MA, delivered the Jackson Memorial Lecture (Predicting the Future of Uveitis) and was presented with the Jackson Memorial Lecture Award during the Opening Session (Sym07; viewable on demand).

The Knights Templar Eye Foundation (KTEF) was recognized by the Visionary Society as a Platinum Level member at the Opening Session (Sym07; viewable on demand). The Visionary Society recognizes distinguished donors who have demonstrated an outstanding commitment to ophthalmology by contributing $1 million or more to the Academy Foundation this year. The Academy and its Foundation appreciate and acknowledge Knights Templar leaders for their tremendous support, commitment, and partnership in providing the single largest gift in Foundation history to support a new virtual reality simulation fund for pediatric ophthalmology on the ONE Network. (In 2025, KTEF was recognized as an Academy Foundation Honoree for its decades-long campaign to protect sight.) 

Matthew S. Oliva, MD, was recognized as an Outstanding Humanitarian Service Award recipient at the Opening Session (Sym07; viewable on demand). He was nominated for the award by the Cure Blindness Project for his dedication to fighting needless blindness and cultivating the next generation of eye care leaders. (The Academy will start accepting nominations for the 2027 award on Dec. 1.) 

Dmytro Pavlenko, MD, was recognized as an Outstanding Humanitarian Service Award recipient at the Opening Session (Sym07; viewable on demand). He was nominated by Kyiv City Clinical Hospital No. 18 for his extraordinary commitment to patients during dangerous and deeply challenging circumstances. (The Academy will start accepting nominations for the 2027 award on Dec. 1.) 

Saraswathy Ramanathan, MD, is the recipient of the Straatsma Award for Excellence in Resident Education and was recognized during the Opening Session (Sym07; viewable on demand). The Association of University Professors of Ophthalmology (AUPO) will present Ramanathan with the award at its AUPO 2027 annual meeting in January.  

George L. Spaeth, MD, was presented with the Laureate Recognition Award, the Academy’s highest honor, during the Opening Session (Sym07; viewable on demand). The Laureate Recognition Award recipient is chosen by the Academy Laureate Selection Committee. 

Nasreen A. Syed, MD, delivered the Zimmerman Lecture (Where Have All the Globes Gone?) and was presented with the Zimmerman Award during the session titled Spooky Tales From the Lab (Sym03; viewable on demand), which is cosponsored by the American Association of Ophthalmic Oncologists and Pathologists.

George A. Williams, MD, is being honored as an Academy Foundation Honoree at Saturday evening’s Illuminate. The Foundation is recognizing Williams for his extraordinary commitment to ophthalmology, philanthropy, and advocacy.   

HONORED ON SUNDAY, OCT 11

Arthur Brant, MD, was presented with the Artemis Award and presented the Artemis Award Talk during the session titled YO Program Part 1—If the Shoe Fits: Choosing the Best Practice Setting for You (Sym36; 9:45-11:00 am; viewable on demand). He also was recognized as this year’s Artemis Award recipient during Saturday’s Opening Session (Sym07; viewable on demand).

Connecticut Society of Eye Physicians (CSEP) was presented with a State Affairs Star Award during the Society Presidents’ Breakfast and Recognition Awards event. The State Affairs Star Award recipients are selected by the Academy Secretariat for State Affairs, and CSEP was honored for its innovative “What Makes a Great Physician” video, which brought together physicians and patients to raise awareness of the growing pressures physicians face and foster greater understanding of the physician experience. 

Jill Annette Foster, MD, FACS, delivered the Wendell L. Hughes Lecture (A Career in Oculoplastic Surgery—Investigation Driven by Surgical Challenges) during the session titled Cutting-Edge Oculoplastic Surgery: Innovations and Practical Integration (Sym28; viewable on demand), which is cosponsored by the American Society of Ophthalmic Plastic and Reconstructive Surgery.

José Gomes, MD, delivered the Whitney G. Sampson Lecture (Global Consensus on Keratoconus—Bridging Evidence, Technology, and Clinical Practice) during the session titled Controversies in Corneal Ectasia: A Global Perspective (Sym39; viewable on demand), which is cosponsored by the Eye and Contact Lens Association.

Cig Harvey delivered the Michael F. Marmor Lecture in Ophthalmology and the Arts (Light, Sight, and Color: A Creative Exploration on Sensory Experience; Sym38; viewable on demand). Harvey, an internationally acclaimed artist, discussed photography as a method of storytelling and how her work explores light, color, and vision.

Jonathan C. Horton, MD, PhD, delivered the William F. Hoyt Lecture (The Optic Discs of Infants and Toddlers Are Nearly Impervious to the Development of Papilledema) and was presented with the Hoyt Award during the session titled From MS to MOGAD: Evolving Concepts in Demyelinating Optic Neuropathies (Sym29; viewable on demand), which is cosponsored by the North American Neuro-Ophthalmology Society.

Mark S. Humayun, MD, PhD, delivered the Arnall Patz Lecture (Retinal Implants to Restore Sight) during the session titled Dry AMD: From Observation to Intervention—What’s Real, What’s Next, and What Matters (Sym35; viewable on demand), which is cosponsored by the Macula Society.

Lauren C. Kiryakoza, MD, shared third place in the Young Ophthalmologist (YO) 1-Minute Video Contest for Open-Sky Secondary Lens Insertion and Penetrating Keratoplasty, which she coproduced with Despoina Theotoka, MD. She was recognized during the session titled YO Program Part 3—The Art of the Difficult Case: Surgeons Present Their Toughest Moments (Sym50; viewable on demand). 

Mahsaw Mansoor, MD, took first place in the Young Ophthalmologist (YO) 1-Minute Video Contest for Intracapsular Cataract Extraction With Cryo and Staged Iris Repair in a Silicone Oil–Filled Eye. She was recognized during the session titled YO Program Part 3—The Art of the Difficult Case: Surgeons Present Their Toughest Moments (Sym50; viewable on demand). 

Seyhan Bahar Özkan, MD, delivered the Marshall M. Parks Lecture (Adventures With Anatomical Variations of Extraocular Muscles—Pearls of Recognition and Management) and was presented with the Parks Lecture Award during the session titled Let’s Be Clear: Pediatric Anterior Segment Made Practical (Sym47; viewable on demand), which is cosponsored by the American Association for Pediatric Ophthalmology and Strabismus.

Louis R. Pasquale, MD, delivered the Robert N. Shaffer Lecture (Exfoliation Glaucoma Reframed) during the session titled Glaucoma Management Beyond Lowering Intraocular Pressure: What Do We Know Now? (Sym34; viewable on demand), which is cosponsored by Prevent Blindness.

Mario Alberto Sánchez Vela, MD, took second place in the Young Ophthalmologist (YO) 1-Minute Video Contest for Cogan Lid Twitch. He was recognized during the session titled YO Program Part 3—The Art of the Difficult Case: Surgeons Present Their Toughest Moments (Sym50; viewable on demand). 

Vincenzo Sarnicola, MD, delivered the Castroviejo Lecture (Deep Anterior Lamellar Keratoplasty: Not Just for Keratoconus Anymore) during the session titled Advancements in Lamellar Keratoplasty (Sym48; viewable on demand), which is cosponsored by the Cornea Society.

Lucia Sobrin, MD, delivered the C. Stephen and Frances Foster Lecture on Uveitis and Immunology (Unmasking Autoimmune Retinopathy: Pearls for Diagnosis and Treatment; Sym45; viewable on demand).

Despoina Theotoka, MD, shared third place in the Young Ophthalmologist (YO) 1-Minute Video Contest for Open-Sky Secondary Lens Insertion and Penetrating Keratoplasty, which she coproduced with Lauren C. Kiryakoza, MD. She was recognized during the session titled YO Program Part 3—The Art of the Difficult Case: Surgeons Present Their Toughest Moments (Sym50; viewable on demand). 

Washington Academy of Eye Physicians and Surgeons (WAEPS) was presented with a State Affairs Star Award during the Society Presidents’ Breakfast and Recognition Awards event. The State Affairs Star Award recipients are selected by the Academy Secretariat for State Affairs, and WAEPS was honored for its work on WAEPS Connect, an innovative year-round program designed to cultivate the next generation of society leaders.

John J. Whyte, MD, MPH, delivered the Parker Heath Lecture (Defining the Role of the Physician in Medicine’s Future) during the session titled Artificial Intelligence, Data, and Health Policy: Driving Equity and Advocacy in Ophthalmology (Sym49; viewable on demand), which is cosponsored by the American Medical Association Ophthalmology Section Council. Whyte is the CEO of the American Medical Association.

HONORED ON MONDAY, OCT 12

Nicole R. Fram, MD, delivered the Charles D. Kelman Lecture (Courage Before Confidence: How Surgeons Are Made) during Spotlight on Cataract: Phaco/IOL Challenges—My Top 5 Pearls (Sym64; viewable on demand).

Michael E. Zegans, MD, delivered the Jones/Smolin Lecture (An Unmet Need: Challenges and Opportunities in the Development of Fungal Keratitis Treatment) during the session titled Combatting and Preparing for Antimicrobial Resistance in Ophthalmology (Sym62; viewable on demand), which is cosponsored by the Ocular Microbiology and Immunology Group. 

The Academy also honors the following award recipients:

 

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Lumenis Launches Ocular Surface Disease Field Guide for Cataract and Refractive Surgeons at AAO https://eyewire.news/news/lumenis-launches-ocular-surface-disease-field-guide-for-cataract-and-refractive-surgeons-at-aao Mon, 12 Oct 2026 14:52:23 GMT https://eyewire.news/news/lumenis-launches-ocular-surface-disease-field-guide-for-cataract-and-refractive-surgeons-at-aao Key Takeaways

  • Lumenis introduced a field guide at AAO 2026 to support ocular surface disease screening and management in cataract and refractive surgery patients

  • Research cited in the guide found abnormal tear test results in 80% of cataract surgery candidates, including 85% of asymptomatic patients

  • The resource includes clinical screening tools, treatment guidance, and strategies for incorporating ocular surface care into surgical workflows

Lumenis has introduced a new clinical field guide designed to help cataract and refractive surgeons identify and manage ocular surface disease (OSD), a potential contributor to patient dissatisfaction despite achieving 20/20 visual acuity.

The guide, "Preventing 20/Unhappy: A Field Guide for Cataract and Refractive Surgeons," was unveiled during the 2026 American Academy of Ophthalmology (AAO) annual meeting in New Orleans.

The resource addresses ocular surface evaluation throughout the surgical journey, emphasizing preoperative screening, individualized treatment planning, and postoperative management.

The guide is organized into 2 sections. "The Read" focuses on clinical considerations, including screening, treatment selection, patient communication, and postoperative care. "The Rollout" provides strategies for integrating ocular surface care into clinical workflows, including staff training and practice implementation.

Developed with insights from 5 cataract and refractive surgeons—Christopher Starr, MD, FACS; Preeya Gupta, MD; Brett Levinson, MD; Shareen Greenbaum, MD; and Eric Gershenbaum, MD—the guide incorporates findings from 6 studies and includes 6 practical clinical tools.

Research highlighted in the guide found that 80% of patients undergoing cataract surgery evaluation had at least 1 abnormal tear test. Among asymptomatic patients, 85% demonstrated at least 1 abnormal result, underscoring the limitations of symptom-based screening alone.

"If you're using symptoms to make a diagnosis, you might miss ocular surface disease because these patients often aren't complaining," Dr. Starr said.

The guide includes a 30-second ocular surface assessment intended to facilitate routine screening in busy surgical practices.

Additional content addresses treatment selection based on disease severity and determining surgical readiness. Among the treatment options discussed is OptiLight, an intense pulsed light device FDA-approved for managing dry eye disease associated with meibomian gland dysfunction.

The field guide is available to read or download through Lumenis.

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Brent Saunders Departs as CEO of Bausch + Lomb https://eyewire.news/news/brent-saunders-departs-as-ceo-of-bausch-lomb Mon, 12 Oct 2026 14:34:10 GMT https://eyewire.news/news/brent-saunders-departs-as-ceo-of-bausch-lomb Brent Saunders, who returned to Bausch + Lomb in 2023 for his second stint as CEO, announced his departure on Monday. 

According to a company statement, he and the company's board of directors mutually agreed to his departure. The companies did not provide additional details regarding the leadership transition.

"When I returned to the company in 2023, I believed Bausch + Lomb had tremendous potential. I saw an iconic brand, talented people and an opportunity to build something special. What we've accomplished together over the past several years has been remarkable," Mr. Saunder stated in a Linkedin post. "We've strengthened the business, advanced our innovation pipeline, invested for the future and built meaningful momentum across the organization. We've delivered strong results, raised our outlook and positioned Bausch + Lomb for long-term success. Most importantly, we've done it while staying focused on what matters most: serving customers, supporting patients and helping people see better to live better."

Mr. Saunders previously served as Bausch + Lomb's CEO from 2010 to 2013 before its sale to Valeant Pharmaceuticals. He also served as CEO of Allergan until it was acquired by AbbVie for $63 billion in 2020. Shortly after his return to B+L, EyewireTV conducted an exclusive interview with him to disuss his career and decision to return. 

Thomas J. Appio, chairman of the Bausch + Lomb Board of Directors and CEO of Bausch Health Companies, has been appointed interim CEO of Bausch + Lomb, effective immediately.

Mr. Appio will continue serving as CEO of Bausch Health while assuming leadership of Bausch + Lomb. Mr. Appio was named chairman of the Bausch + Lomb board in August 2026. The board cited his familiarity with the business, international leadership experience, and longstanding relationship with Bausch + Lomb as qualifications for the interim role.

Mr. Appio has served as CEO of Bausch Health since 2022. During his tenure, Bausch Health, excluding Bausch + Lomb, has reported 13 consecutive quarters of year-over-year growth in revenue and adjusted EBITDA, a non-GAAP financial measure, according to B+L. His experience with Bausch + Lomb dates to 2010, when he joined the company as managing director for China. In 2016, he became president of Bausch + Lomb International, a position he held before the company's initial public offering in 2022.

The companies did not announce a timeline for appointing a permanent CEO.

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Claris Biotherapeutics Reports Positive Phase 2 Data for CSB-001 in Limbal Stem Cell Deficiency https://eyewire.news/news/claris-biotherapeutics-reports-positive-phase-2-data-for-csb-001-in-limbal-stem-cell-deficiency Sun, 11 Oct 2026 17:48:24 GMT https://eyewire.news/news/claris-biotherapeutics-reports-positive-phase-2-data-for-csb-001-in-limbal-stem-cell-deficiency Key Takeaways

  • At Week 20, 41.4% of CSB-001-treated eyes gained at least 15 BCVA letters, compared with none of the untreated eyes

  • Visual acuity improvements persisted for up to 16 weeks after treatment, and CSB-001 was generally well tolerated

  • Claris plans to begin 2 pivotal trials involving approximately 400 patients in the first half of 2027

Claris Biotherapeutics announced positive results from an open-label proof-of-concept study evaluating CSB-001 (oremepermin alfa ophthalmic solution) in patients with limbal stem cell deficiency (LSCD). The findings were presented at the American Academy of Ophthalmology (AAO) 2026 Annual Meeting in New Orleans.

The study (NCT06452316) evaluated 49 eyes from 39 patients with central corneal conjunctivalization and baseline best-corrected visual acuity (BCVA) of 65 letters or fewer. Of these, 29 eyes from 23 patients received topical CSB-001 four times daily during two 8-week treatment periods separated by a 1-month dosing holiday. The remaining 20 eyes from 16 patients served as untreated controls.

At Week 20, 41.4% of CSB-001-treated eyes achieved gains of at least 15 BCVA letters, while 55.2% gained at least 10 letters. Overall, 76% of treated eyes demonstrated some visual acuity improvement.

In comparison, no untreated eyes achieved gains of 15 letters or more, and 5% gained at least 10 letters.

Visual improvements persisted following treatment discontinuation. Among treated eyes achieving gains of at least 15 or 10 letters at Week 20, 50% and 81%, respectively, maintained those improvements for an additional 16 weeks.

Investigators also reported a strong correlation between anatomical improvements and visual acuity gains. CSB-001 was generally safe and well tolerated.

CSB-001 contains recombinant human deleted hepatocyte growth factor (dHGF), which is designed to promote corneal epithelial regeneration while modulating inflammation and fibrosis.

Claris plans to initiate 2 pivotal, vehicle-controlled studies in the first half of 2027, enrolling approximately 400 patients with LSCD. Unlike the proof-of-concept study, the pivotal trials will use continuous dosing, with visual acuity as the primary efficacy endpoint supported by anatomical assessments.

Currently, no pharmacologic treatments are approved for LSCD.

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Glaukos Reports Positive Phase 4 Results for iDose TR Combined with Cataract Surgery https://eyewire.news/news/glaukos-reports-positive-phase-4-results-for-idose-tr-combined-with-cataract-surgery Fri, 09 Oct 2026 16:17:14 GMT https://eyewire.news/news/glaukos-reports-positive-phase-4-results-for-idose-tr-combined-with-cataract-surgery Key Takeaways

  • The Phase 4 GLK-101-04 trial met its primary endpoint, demonstrating statistically significant superiority in IOP reduction with iDose TR plus cataract surgery compared with cataract surgery alone

  • Mean diurnal IOP decreased by 11.1 mmHg in the combination group versus 7.4 mmHg with cataract surgery alone at month 3 (P<.0001)

  • No treatment-related corneal endothelial cell loss or cystoid macular edema adverse events were reported through 3 months, supporting a favorable short-term safety profile

Glaukos announced positive topline results from its phase 4 GLK-101-04 clinical trial evaluating iDose TR administered in conjunction with cataract surgery in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).

The study met its primary efficacy endpoint, demonstrating statistically significant superiority in mean diurnal IOP reduction at 3 months compared with cataract surgery alone.

Patients receiving iDose TR with cataract surgery achieved a mean diurnal IOP reduction of 11.1 mmHg from baseline, compared with 7.4 mmHg in patients undergoing cataract surgery alone. The incremental treatment effect was 3.6 mmHg (P<.0001).

Glaukos also reported statistically significant superiority across all prespecified secondary responder analyses.

The prospective, multicenter, randomized, double-masked, parallel-group trial included 149 study eyes, with 74 assigned to iDose TR plus cataract surgery and 75 assigned to cataract surgery alone. The primary endpoint assessed change from baseline in mean diurnal IOP at month 3.

According to Glaukos, iDose TR demonstrated a favorable safety profile through 3 months. No treatment-related adverse events involving corneal endothelial cell loss or cystoid macular edema were reported, and no serious corneal adverse events occurred.

“These data further reinforce the versatility of iDose TR across various administration settings, demonstrating its ability to deliver clinically meaningful robust IOP reduction whether administered as a standalone procedure or in conjunction with cataract surgery,” Thomas Burns, chairman and CEO of Glaukos, said in a company statement.

iDose TR is a long-duration intracameral implant designed to continuously deliver a proprietary formulation of travoprost for up to 3 years. The therapy is intended to reduce reliance on daily topical glaucoma medications and address challenges associated with treatment adherence.

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Perceive Bio Completes Phase 2a Enrollment in VOY-101 Gene Therapy Study for Geographic Atrophy https://eyewire.news/news/perceive-bio-completes-phase-2a-enrollment-in-voy-101-gene-therapy-study-for-geographic-atrophy Fri, 09 Oct 2026 16:12:20 GMT https://eyewire.news/news/perceive-bio-completes-phase-2a-enrollment-in-voy-101-gene-therapy-study-for-geographic-atrophy Key Takeaways

  • The Phase 2a JOURNEY study completed enrollment of 94 eyes from 47 participants, exceeding its planned target of 62 eyes

  • VOY-101 is an investigational, single-injection gene therapy targeting complement factor H, with the primary endpoint assessing GA lesion growth at Month 15

  • Topline Phase 2a data are expected in late 2027, and Perceive Bio has appointed former Iveric Bio executive Tony Gibney to its board of directors

Perceive Biotherapeutics has completed enrollment in the phase 2a portion of its phase 1/2a JOURNEY study (PBI-AMD-002), evaluating VOY-101, an investigational gene therapy for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

The study enrolled 94 eyes from 47 participants, exceeding the company's original target of 62 eyes. Topline results from the 15-month primary endpoint are expected in late 2027.

JOURNEY is a randomized, open-label, multicenter study evaluating a single intravitreal injection of VOY-101 at the recommended phase 2 dose established during Phase 1.

Participants have bilateral GA lesions of comparable size. One eye was randomly selected to receive VOY-101, while the untreated fellow eye serves as a within-patient control. This design is intended to account for factors such as genetics, age, and environmental exposures that may influence disease progression.

The primary endpoint is the change in GA lesion size at Month 15. Secondary endpoints include GA lesion growth through Month 24, visual acuity and visual function, development of macular neovascularization, and safety and tolerability.

“VOY-101 is designed as a one-time treatment that restores the body's own protective regulation of the complement pathway in patients at elevated risk of progression,” said K. Angela Macfarlane, CEO of Perceive Bio, in a company statement.

Ms. Macfarlane noted that currently approved GA therapies require repeated intravitreal injections, highlighting the potential clinical relevance of a durable treatment approach.

Perceive Bio also announced the appointment of Tony Gibney as an independent member of its board of directors.

Mr. Gibney brings more than 30 years of biotechnology finance, business development, and strategic leadership experience. He previously served as executive vice president and chief business and strategy officer at Iveric Bio before its acquisition by Astellas Pharma in 2023.

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BioTissue to Present Phase 2 TTAX03 Dry Eye Disease Study Results at AAO https://eyewire.news/news/biotissue-to-present-phase-2-ttax03-dry-eye-disease-study-results-at-aao Fri, 09 Oct 2026 16:07:03 GMT https://eyewire.news/news/biotissue-to-present-phase-2-ttax03-dry-eye-disease-study-results-at-aao Key Takeaways

  • A Phase 2 randomized, double-masked, multicenter study evaluated 3 concentrations of TTAX03 against saline control in 74 adults with mild to moderate dry eye disease

  • No treatment-related serious adverse events were reported, and the highest dose demonstrated the greatest improvements in dry eye symptoms and corneal staining outcomes

BioTissue will present results from a phase 2 clinical study evaluating the safety and potential efficacy of investigational TTAX03 in patients with mild to moderate dry eye disease (DED) at the American Academy of Ophthalmology (AAO) 2026 annual meeting in New Orleans.

The prospective, randomized, controlled, double-masked, multicenter study enrolled 74 adults who were randomized in a 1:1:1:1 ratio to receive 1 of 3 TTAX03 concentrations or saline control. Each treatment was administered under a bandage contact lens for 5 days.

The study's primary objective was to evaluate ocular and general safety through 12 weeks.

According to BioTissue, no treatment-related serious adverse events were reported in any treatment group.

The highest TTAX03 concentration demonstrated the greatest improvements in overall symptoms and eye dryness, as measured by the visual analogue scale (VAS). This group also showed a higher incidence of complete resolution of corneal staining and changes in best-corrected visual acuity (BCVA) at Day 85.

The findings suggest a favorable preliminary safety profile, with the highest dose showing the greatest improvements in clinical signs and patient-reported symptoms. However, additional studies are needed to further assess efficacy and determine the optimal dose and treatment regimen.

“Dry eye is not a one-size-fits-all condition, making ongoing exploration into new approaches especially important,” said Ted Davis, president and CEO of BioTissue, in a company statement.

BioTissue noted that its development of regenerative products derived from human birth and placental tissues continues to inform its investigation of new therapeutic applications.

The findings will be presented during the AAO Annual Meeting, scheduled for October 9–12, 2026, in New Orleans.

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Carrot to Acquire GreenMan Vision, Expanding VR Platform into IOL Simulation for Cataract Surgery https://eyewire.news/news/carrot-to-acquire-greenman-vision-expanding-vr-platform-into-iol-simulation-for-cataract-surgery Fri, 09 Oct 2026 15:56:17 GMT https://eyewire.news/news/carrot-to-acquire-greenman-vision-expanding-vr-platform-into-iol-simulation-for-cataract-surgery Key Takeaways

  • Carrot has announced an agreement to acquire GreenMan Vision, bringing InSightVR IOL simulation technology into its existing VR diagnostic platform

  • A retrospective study of 609 patients reported advanced-technology IOL selection rates of 57.1% with InSightVR compared with 28.4% with standard counseling.

Carrot, formerly known as Virtual Field, has announced an agreement to acquire GreenMan Vision, developer of the InSightVR IOL simulation technology. The acquisition will expand Carrot's virtual reality (VR) diagnostic platform into vision simulation, providing cataract surgeons with a tool to help patients evaluate IOL options before surgery.

The addition of InSightVR will allow Carrot to extend its capabilities beyond visual testing and diagnostics to support patient education and decision-making during cataract surgery consultations.

“For years, Carrot has shown doctors how their patients see. Soon, we’ll be able to show patients how they could see,” said Jeremy Barlow, CEO of Carrot, in a company news release. “The best decisions in eye care are the ones patients can see for themselves.”

Carrot's VR-based visual testing platform is currently used in more than 2,500 clinics, including independent practices and larger ophthalmology and optometry networks, according to the company. The platform incorporates artificial intelligence and machine learning-derived analysis and automation to streamline visual testing, reduce technician workload, and improve the patient examination experience.

With the acquisition of GreenMan Vision, Carrot plans to introduce IOL simulation capabilities that allow patients to experience potential visual outcomes associated with different lens technologies.

InSightVR was developed by cataract surgeons Michael Greenwood, MD, and Brandon Baartman, MD, of Vance Thompson Vision, to address challenges associated with counseling patients about IOL selection.

The technology uses individual patient biometry to simulate visual experiences across everyday activities, including reading and night driving. Patients can compare potential differences among major IOL categories, including tradeoffs involving spectacle dependence, glare, and halos.

“We built InSightVR for our own patients, and we held it to one standard: it could never overpromise an outcome,” Dr. Greenwood said in the release.

The company cited findings from a 2026 retrospective study involving 609 patients, published in Patient Preference and Adherence, that evaluated IOL selection among patients who received InSightVR simulation compared with those who underwent standard counseling. According to the study results reported in the release, 57.1% of patients who used InSightVR selected an advanced-technology IOL, compared with 28.4% of patients who received standard counseling.

Additionally, 90% of surveyed patients who selected advanced-technology lenses reported that their postoperative vision was similar to the preoperative simulation.

The retrospective findings suggest that immersive visualization may influence patient preferences during IOL selection. However, the study design does not establish that simulation alone caused the difference in lens selection.

The acquisition is expected to expand access to InSightVR through Carrot's existing network of ophthalmology and optometry practices. According to the companies, existing InSightVR customers will continue working with the same support team and receiving hands-on training as the technology transitions to the Carrot Platform.

“Our customers will keep the same InSightVR team and the hands-on training and support they rely on,” said Matt Larson, CEO of GreenMan Vision, in the release. “What will change is scale. With Carrot, InSightVR will get in front of more surgeons and more patients than we could ever reach alone.”

Carrot indicated that integrating diagnostic testing and IOL simulation into a single platform could support care across the patient journey, from initial vision assessments and optometric referrals through cataract surgery consultations.

Financial terms of the acquisition were not disclosed in the announcement.

Technology to be showcased at AAO 2026

Carrot plans to demonstrate its platform and IOL simulation capabilities during the American Academy of Ophthalmology 2026 Annual Meeting exhibition in New Orleans, October 10–12, 2026.

Attendees can view demonstrations at Carrot booth #2409 and the GreenMan InSightVR booth #4142.

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Stuart Therapeutics Submits FDA Amendment to Evaluate ST-100 in Corneal Wound Healing https://eyewire.news/news/stuart-therapeutics-submits-fda-amendment-to-evaluate-st-100-in-corneal-wound-healing Fri, 09 Oct 2026 15:43:42 GMT https://eyewire.news/news/stuart-therapeutics-submits-fda-amendment-to-evaluate-st-100-in-corneal-wound-healing Key Takeaways

  • Stuart Therapeutics submitted an IND amendment to the FDA to investigate ST-100 (vezocolmitide) in corneal wound healing, marking the investigational therapy's first proposed expansion beyond dry eye disease

  • The company plans a proof-of-concept study followed by a phase 2 trial in the second half of 2027 evaluating ST-100 in corneal wounds caused by trauma, surgery, ulcers, and chemical burns

Stuart Therapeutics announced that it has submitted an investigational new drug (IND) application amendment to the FDA to evaluate ST-100 (vezocolmitide), its investigational collagen-repair therapy, in patients with corneal wounds.

The planned proof-of-concept study represents the company's first effort to expand the clinical development of ST-100 beyond dry eye disease. The investigational therapy is designed to selectively repair damaged helical collagen, with the goal of supporting corneal epithelial and stromal healing.

According to the company, the expanded development program could establish ST-100 as a potential treatment for corneal damage associated with trauma, surgery, ulcers, chemical burns, and other causes of ocular surface injury.

ST-100 is being developed as a novel therapeutic approach targeting damaged helical collagen, a structural component of ocular tissues. The planned proof-of-concept study will investigate whether the therapy can support epithelial and stromal repair following corneal injury.

Unlike conventional approaches that primarily protect the ocular surface and support the eye's natural healing processes, ST-100 is intended to act directly on damaged collagen structures. The company believes this mechanism could provide therapeutic benefits across multiple types of corneal wounds, regardless of the underlying cause.

"Expanding ST-100 beyond dry eye disease into corneal wound healing has the potential to give physicians an important new tool for treating ocular surface damage," said Eric Schlumpf, president and CEO of Stuart Therapeutics. "We believe ST-100 is capable of repairing ocular helical collagen damaged by trauma, surgery and chemical burns, a need no currently approved therapeutic directly addresses. If our clinical program bears this out, ST-100 could become a topical therapy for a broad range of ocular surface conditions."

The proposed mechanism and potential clinical benefits in corneal wound healing remain investigational and will require confirmation in clinical studies.

Following the initial proof-of-concept study, Stuart Therapeutics plans to initiate a phase 2 clinical trial in the second half of 2027.

The planned trial will evaluate ST-100 across several categories of corneal wounds, including injuries resulting from trauma, ophthalmic surgery, corneal ulcers, and chemical burns. The study is intended to generate additional evidence regarding the therapy's potential to promote ocular surface repair.

According to Stuart Therapeutics, phase 2 and initial phase 3 studies involving more than 250 patients demonstrated clinically meaningful improvements in corneal fluorescein staining, an established measure of ocular surface epithelial damage.

The company also reported improvements in dry eye symptoms compared with vehicle, with treatment effects observed as early as Day 2.

These findings provide the rationale for investigating whether ST-100's proposed collagen-repair mechanism could offer benefits in other ocular surface conditions characterized by tissue damage.

Stuart Therapeutics plans to initiate a phase 3 registration trial of ST-100 for dry eye disease in early 2027, while pursuing the separate corneal wound healing development program.

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RadiusXR and Topcon Healthcare Introduce InspirePRO Wearable Perimeter at AAO https://eyewire.news/news/radiusxr-and-topcon-healthcare-introduce-inspirepro-wearable-perimeter-at-aao Fri, 09 Oct 2026 15:36:06 GMT https://eyewire.news/news/radiusxr-and-topcon-healthcare-introduce-inspirepro-wearable-perimeter-at-aao RadiusXR and its strategic partner Topcon Healthcare introduced InspirePRO, a new wearable visual field testing platform designed to support glaucoma diagnosis and monitoring across the full spectrum of disease severity, at the American Academy of Ophthalmology (AAO) 2026 annual meeting in New Orleans.

The portable perimeter incorporates purpose-built hardware, advanced eye tracking, and integrated clinical software to provide visual field measurements from the earliest detectable defects through advanced glaucoma. According to the companies, InspirePRO is designed to address limitations associated with conventional perimetry while improving patient comfort, testing flexibility, and workflow efficiency across clinical settings.

InspirePRO is designed to deliver a full measurement range using background brightness comparable to that of conventional perimetry. Unlike systems that approximate certain testing parameters through software, the platform uses custom hardware engineered specifically for visual field assessment.

According to RadiusXR, the expanded measurement range allows clinicians to quantify visual field loss in patients with advanced glaucoma, potentially reducing the need for practices to maintain separate standalone perimeters for different stages of disease. The system is also designed to support consistent longitudinal testing as patients progress from early to advanced glaucoma.

"InspirePRO is the next evolution of the Inspire hardware platform," said Ammad Khan, CEO of RadiusXR. "Because we design and build our own hardware, we can quickly turn lessons from the clinic into significant improvements. Each generation of Inspire has been shaped by real-world clinical use, and InspirePRO is our biggest step forward. Clinicians can now rely on one wearable system throughout every stage of glaucoma."

Custom display and high-speed eye tracking

InspirePRO incorporates a custom display designed to provide the brightness needed to measure visual field defects across a broad range of disease severity. RadiusXR stated that the system's display capabilities allow clinicians to quantify visual function loss extending into advanced glaucoma.

The platform also features high-speed eye tracking designed to continuously monitor fixation without obstructing the patient's field of view. By tracking eye position throughout testing, the system can adjust stimulus presentation and scoring based on where the patient is looking, an approach intended to improve measurement consistency and reduce errors associated with fixation instability.

According to RadiusXR, the eye-tracking technology may also support future applications in oculomics, an emerging field investigating ocular measurements as potential indicators of systemic health and disease.

In addition to its measurement capabilities, InspirePRO incorporates several features intended to improve comfort and accessibility during visual field testing.

The wearable platform includes independent refractive adjustment, an adaptable fit system, modular light seals, and integrated sound-isolating speakers.

The system's portable design also allows it to be moved between examination rooms and clinical environments, potentially offering greater flexibility than traditional stationary perimeters.

"In glaucoma care, visual function needs to be assessed from the earliest detectable loss through advanced disease," said Robert N. Weinreb, MD, distinguished professor of ophthalmology at the University of California San Diego. "A wearable perimeter that covers that full range and is comfortable for repeated testing should help clinicians follow patients more consistently over time."

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Haag-Streit Launches Eyesi Surgical 3.0 Virtual Reality Training Platform at AAO https://eyewire.news/news/haag-streit-launches-eyesi-surgical-30-virtual-reality-training-platform-at-aao-2026 Fri, 09 Oct 2026 15:22:59 GMT https://eyewire.news/news/haag-streit-launches-eyesi-surgical-30-virtual-reality-training-platform-at-aao-2026 Key Takeaways

  • Haag-Streit introduced Eyesi Surgical 3.0 at AAO 2026, expanding virtual reality-based training capabilities for cataract and vitreoretinal surgery across different levels of surgical experience

  • The platform incorporates new plunger-operated injectors, a combined anterior and posterior segment interface, and redesigned ergonomic features to provide more realistic surgical training

  • Eyesi Surgical 3.0 is designed to support continuous surgical skill development beyond residency, offering advanced simulation scenarios that allow surgeons to practice complex techniques without risk to patients

Haag-Streit announced the global launch of Eyesi Surgical 3.0, the latest generation of its virtual reality-based ophthalmic surgical training platform, at the American Academy of Ophthalmology (AAO) 2026 annual meeting, held October 9-13 in New Orleans.

The updated platform introduces new hardware and software designed to expand surgical simulation beyond foundational cataract training, providing advanced training opportunities for both developing and experienced ophthalmic surgeons.

According to the company, Eyesi Surgical 3.0 builds on more than 20 years of simulator development and incorporates increasingly complex surgical scenarios intended to support continuous skill development while eliminating patient risk during training.

Eyesi Surgical 3.0 features a redesigned interface that supports both anterior and posterior segment surgical training within a single system.

For cataract surgery, the simulator includes 8 incision sites around the model eye's cornea, allowing surgeons to practice procedures from either temporal or superior approaches. For vitreoretinal procedures, the platform incorporates 2 pars plana ports.

The combined patient head design also provides a foundation for potential future training applications, including pars plana anterior vitrectomy.

According to Haag-Streit, these capabilities are intended to support a broader range of surgical techniques and enable users to progress from fundamental skills to more complex procedures.

The platform introduces 2 hand-operated injectors designed to more closely reproduce the tactile and mechanical actions involved in ophthalmic surgery. The injectors incorporate plunger-based operation, allowing users to simulate fluid and material delivery during procedures such as hydrodissection, anterior chamber management with ophthalmic viscosurgical devices, and intraocular lens implantation.

By more closely replicating the handling of surgical instruments, the updated hardware aims to improve the realism of simulation-based training and facilitate the transfer of technical skills to the operating room.

In addition to procedural simulation, Eyesi Surgical 3.0 incorporates redesigned ergonomic features intended to help surgeons develop appropriate positioning and movement patterns during surgery. The platform includes a redesigned operating table, repositioned foot switches, and a tiltable microscope. These modifications are designed to encourage proper ergonomics during routine simulation exercises, allowing surgeons to practice not only intraocular maneuvers but also the physical positioning and coordination required in the operating room.

"The new Eyesi Surgical platform 3.0 marks a watershed moment in virtual reality surgical training," said Marshall Dial, vice president of education and simulation market development at Haag-Streit Group. "Over the past 20 years, simulation has become widely accepted for teaching novice ophthalmic surgeons foundational skills, and numerous peer-reviewed studies validate this efficacy."

The new platform extends these benefits to experienced surgeons through complex advanced training scenarios that support continuous improvement in surgery," Mr. Dial said.

Haag-Streit is showcasing Eyesi Surgical 3.0 at booth 707 during AAO 2026 in New Orleans, where attendees can view the platform following its global introduction.

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Innovent's Sycume Meets Primary Endpoint in Phase 3 Trial for Inactive Thyroid Eye Disease (TED) https://eyewire.news/news/innovents-sycume-meets-primary-endpoint-in-phase-3-trial-for-inactive-thyroid-eye-disease-ted Fri, 09 Oct 2026 15:09:32 GMT https://eyewire.news/news/innovents-sycume-meets-primary-endpoint-in-phase-3-trial-for-inactive-thyroid-eye-disease-ted Key Takeaways

  • Sycume (IBI311) met the primary endpoint of the phase 3 RESTORE-3 trial, achieving a 60.4% proptosis response rate at Week 24 compared with 23.5% for placebo in patients with inactive thyroid eye disease

  • Treatment resulted in statistically significant reductions in proptosis in both study and non-study eyes, with most treatment-emergent adverse events reported as mild to moderate and no new safety signals identified

  • The findings support the potential use of IGF-1R inhibition as a nonsurgical treatment option for patients with chronic, inactive TED, with longer-term follow-up and complete study results still pending

Innovent Biologics announced that Sycume (teprotumumab N01 injection; IBI311), its independently developed recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody, met the primary endpoint in the phase 3 RESTORE-3 clinical trial evaluating the treatment in Chinese patients with inactive thyroid eye disease (TED).

The multicenter, randomized, double-blind, placebo-controlled study demonstrated statistically significant improvements in proptosis response rates and reductions in proptosis at Week 24 compared with placebo. According to the company, the investigational treatment also demonstrated a favorable safety and tolerability profile, with no new safety signals identified.

The findings provide additional clinical evidence supporting IGF-1R inhibition in patients with chronic, inactive TED, a population with historically limited nonsurgical treatment options.

RESTORE-3 study design and patient characteristics

RESTORE-3 enrolled 116 patients with inactive TED who were randomized in an approximately 2:1 ratio to receive IBI311 or placebo.

The study's primary endpoint was the proptosis response rate in the study eye at Week 24, while the key secondary endpoint evaluated change from baseline in study-eye proptosis at the same time point. Eligible participants had inactive disease, defined by a bilateral Clinical Activity Score (CAS) of 2 or lower.

At baseline, participants had a mean disease duration of 4.3 years and a mean study-eye proptosis measurement of 22.16 mm. Approximately 74.1% of patients had a baseline CAS of 0 or 1, indicating minimal inflammatory activity. These characteristics reflect a population with longstanding TED in which inflammation had largely subsided but residual proptosis remained.

Significant improvements in proptosis observed at Week 24

The trial met its primary endpoint, with a significantly greater proportion of patients receiving IBI311 achieving a proptosis response compared with those receiving placebo.

At Week 24, the proptosis response rate in the study eye was 60.4% in the IBI311 group compared with 23.5% in the placebo group, representing a treatment difference of 36.9 percentage points (P = .0003).

The study also met its key secondary endpoint, demonstrating a statistically significant reduction in study-eye proptosis. The least-squares mean change from baseline was −1.88 mm in the IBI311 group compared with −0.88 mm in the placebo group, resulting in a treatment difference of −1.00 mm (P < .0001).

Additional secondary analyses demonstrated improvements in the non-study eye, suggesting that the treatment effect extended beyond the designated study eye. At Week 24, the non-study-eye proptosis response rate was 46.0% with IBI311 compared with 19.8% with placebo (P = .0071). The least-squares mean change in non-study-eye proptosis was −1.77 mm in the treatment group compared with −0.91 mm in the placebo group (P < .0001).

According to Innovent, the results were generally consistent with previously reported findings for Tepezza (teprotumumab) in inactive TED. However, the company noted that baseline mean proptosis was lower in RESTORE-3 than in the Tepezza study. Because these findings represent an indirect comparison across separate trials, they do not establish comparative efficacy between the treatments.

IBI311 demonstrated a favorable safety and tolerability profile during the double-blind treatment and follow-up period, according to the company. Most treatment-emergent adverse events were mild to moderate in severity, and investigators identified no new safety signals.

Patient follow-up remains ongoing, and Innovent indicated that complete study findings will be presented at future scientific conferences or published in peer-reviewed journals.

Potential implications for inactive TED management

Inactive TED represents a substantial proportion of the overall TED population, with Innovent estimating that approximately two-thirds of patients have inactive disease.

Although inflammatory activity may decrease over time, patients can continue to experience persistent proptosis, changes in appearance, and functional impairment. Historically, rehabilitative surgery has been a principal treatment option for patients with residual manifestations of inactive TED.

Sycume is an IGF-1R-targeting monoclonal antibody developed by Innovent Biologics for the treatment of TED. According to the company, Sycume is the first IGF-1R antibody approved in China and the second approved worldwide for TED.

Lei Qian, MD, chief R&D officer for the general biomedicine pipeline at Innovent Biologics, said the findings represent an important milestone in the company's efforts to expand treatment options for TED.

"With these positive Phase III trial results, Sycume now achieves comprehensive disease coverage ranging from 'early acute control' to 'chronic phase tissue remodeling,'" Dr. Qian said.

Dr. Qian added that Innovent plans to collaborate with clinical experts to translate the findings into clinical practice and expand access to treatment.

Although the results support the potential clinical benefit of IBI311 in inactive TED, additional data will be needed to assess the durability of proptosis reduction, longer-term safety, and effects on other patient-centered outcomes. The ongoing RESTORE-3 follow-up and subsequent publication of complete results are expected to provide further insight into the role of IGF-1R inhibition in the management of chronic, inactive TED.

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Life Biosciences Announces First-in-Human Data from Ongoing Phase 1 Trial Evaluating ER-100 in Optic Neuropathies https://eyewire.news/news/life-biosciences-announces-first-in-human-data-from-ongoing-phase-1-trial-evaluating-er-100-in-optic-neuropathies Fri, 09 Oct 2026 14:51:36 GMT https://eyewire.news/news/life-biosciences-announces-first-in-human-data-from-ongoing-phase-1-trial-evaluating-er-100-in-optic-neuropathies Key Takeaways

  • ER-100 was well tolerated through Day 56 in the first 3 patients with open-angle glaucoma, with no dose-limiting toxicities, serious adverse events, or adverse events of special interest reported

  • Two participants demonstrated greater than 4 dB improvements at at least 28% of tested visual field locations, although efficacy cannot be established from these early findings.

Life Biosciences announced interim data from its phase 1 clinical trial of ER-100 in three participants with open angle glaucoma (OAG). The data demonstrated that a single intravitreal administration along with daily oral doxycycline was well-tolerated through Day 56 in all three participants and showed preliminary signals of improvement in visual field testing in two participants.

“These initial results provide early information regarding the tolerability of ER-100 and epigenetic restoration in people with open angle glaucoma. We are encouraged by the Data Safety Monitoring Board’s recommendation to escalate to Dose Level 2, a decision that allows us to keep moving this trial forward on behalf of people living with optic neuropathies like glaucoma, a disease where vision loss is often considered irreversible,” said Sharon Rosenzweig-Lipson, Ph.D., Chief Scientific Officer of Life Bio. “While this Phase 1 study is designed to evaluate safety and tolerability, the preliminary observations of visual field improvements in two participants are encouraging as we continue to advance the ER-100 program. This milestone marks an important step in Life Bio’s progress translating epigenetic restoration into a new class of medicines for age-related diseases.”

Presentation highlights:

Safety and Tolerability Observations

  • A single intravitreal administration of Dose Level 1 ER-100 (2×1011 vg) along with daily oral doxycycline to induce OSK expression was well-tolerated in 3 participants with open angle glaucoma (OAG) through Day 56
  • There were no reported dose-limiting toxicities, adverse events of special interest or serious adverse events
  • All reported adverse events were related to procedure, steroid, or pre-existing conditions and were not directly associated with ER-100
  • Data Safety Monitoring Board recommendation was to escalate to Dose Level 2 (6×1011 vg) in OAG participants, with the trial currently ongoing

Visual Field Observations

  • Improvements in Humphrey Visual Fields measurements, a standard eye exam that measures a participant’s ability to detect light across many points in their field of vision, scored in decibels (dB), were observed in 2 of 3 OAG participants at Day 56
  • In each of these 2 participants, ≥ 28% of points in the visual fields showed a > 4 dB improvement

This first-in-human, phase 1, open-label clinical trial (NCT07290244) is evaluating the safety and tolerability of ER-100 in adults with optic neuropathies. ER-100 uses controlled expression of three transcription factors, OSK (OCT4, SOX2, KLF4), delivered via a single intravitreal injection, with OSK expression induced by systemic doxycycline administered for 8 weeks (56 days). An oral prednisolone taper is administered to minimize risk of inflammation due to AAV-2 immune response. Multiple study visits assessing tolerability and visual endpoints were included in this first 56 day evaluation.

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Iantrek Reports 37.2% IOP Reduction at 6 Months with Bio-Reinforced Canaloplasty https://eyewire.news/news/iantrek-reports-372-iop-reduction-at-6-months-with-bio-reinforced-canaloplasty Thu, 08 Oct 2026 15:13:31 GMT https://eyewire.news/news/iantrek-reports-372-iop-reduction-at-6-months-with-bio-reinforced-canaloplasty Key Takeaways

  • Bio-reinforced canaloplasty combined with cataract surgery produced a 37.2% mean IOP reduction and a 49.1% decrease in glaucoma medication use at 6 months in 52 eyes

  • No serious ocular adverse events or secondary IOP-lowering surgeries were reported through 6 months, while 2 upcoming AAO 2026 presentations will examine bio-reinforced cyclodialysis outcomes

  • Iantrek is continuing the BOOST clinical study of AlloSpan Canal and anticipates commercial introduction in 2027, pending further clinical and development milestones.

Iantrek has announced topline 6-month results from a first-in-human, investigator-initiated study evaluating bio-reinforced canaloplasty in combination with cataract surgery, reporting a 37.2% reduction in mean IOP and a 49.1% reduction in glaucoma medication use.

The findings, involving 52 treated eyes, provide early clinical evidence supporting the company's bio-interventional ophthalmic surgery (BIOS) approach to the trabecular outflow pathway. The company is also preparing to present additional data on bio-reinforced cyclodialysis targeting the uveoscleral outflow pathway at the 2026 American Academy of Ophthalmology (AAO) annual meeting, October 9-12, in New Orleans.

According to Iantrek, mean IOP decreased 37.2% from a baseline of 22.4 mmHg at 6 months following bio-reinforced canaloplasty combined with cataract surgery. Additionally, 90% of treated eyes achieved an IOP of 18 mmHg or lower. Mean glaucoma medication use decreased 49.1% from a baseline of 1.2 medications.

The company reported no serious ocular adverse events, and no eyes required secondary surgical intervention for IOP control during the 6-month follow-up period.

"With more than 10,000 bio-reinforced cyclodialysis procedures now performed in the US to enhance uveoscleral outflow, we're excited to bring that same restorative, natural approach to the complementary outflow pathway with bio-reinforced canaloplasty," said Adam Szaronos, chief executive officer of Iantrek. "These early results support our belief in a simple concept: pairing established surgical interventions with homologous tissue to help surgeons restore and reinforce the eye's natural outflow pathways. That is the foundation of bio-interventional ophthalmic surgery."

CREST study findings to be presented at AAO

In addition to the canaloplasty findings, Iantrek will present 2 analyses from the CREST study evaluating cyclodialysis with allograft scleral reinforcement.

The presentations will address surgical outcomes and ocular safety across more than 500 cases, as well as 1-year IOP outcomes associated with the use of 1 versus 2 allograft spacers.

Reena Garg, MD, will present "Surgical Outcomes, Ocular Safety and Tolerability of Bio-Interventional Cyclodialysis With Allograft Scleral Reinforcement: Clinical Experience of More Than 500 Cases." The analysis, coauthored by Jason Bacharach, MD, is scheduled for Sunday, October 11, at 3:30 p.m. in the Poster Theater, Hall C, as part of session PO074.

A second presentation, "One-Year IOP Dose-Response Results of 1 vs. 2 Bio-Interventional Allograft Spacers Following Ab Interno Cyclodialysis in Combination With Cataract Surgery," will be available on demand. Doug McGraw, DO, will present the findings as part of session PO412.

Together, the analyses are expected to provide additional information about the clinical performance of bio-reinforced cyclodialysis, including procedural safety and the potential relationship between the number of allograft spacers and postoperative IOP outcomes.

Iantrek's BIOS platform is designed to reinforce the eye's natural aqueous humor outflow pathways through the incorporation of homologous allograft tissue into established glaucoma surgical techniques.

The company's bio-reinforced cyclodialysis approach targets the uveoscleral outflow pathway, while its bio-reinforced canaloplasty procedure, AlloSpan Canal, targets the trabecular outflow pathway.

According to Iantrek, approximately 3.5 million eyes in the United States have previously undergone minimally invasive glaucoma surgery (MIGS), representing a potentially substantial population requiring additional treatment as glaucoma progresses. The company also estimates that approximately 400,000 canal-based procedures are performed annually.

Iantrek is continuing to evaluate AlloSpan Canal through the ongoing BOOST clinical study at select US sites.

The procedure combines canal dilation with internal structural reinforcement using homologous allograft tissue. According to the company, this approach is intended to extend the principles of bio-interventional ophthalmic surgery to the conventional trabecular outflow pathway.

Iantrek stated that the procedure is reported under the established Category I Current Procedural Terminology (CPT) code 66175. The company also noted that AAO issued reimbursement guidance related to the procedure earlier in 2026.

Iantrek anticipates introducing AlloSpan commercially in 2027. Additional BOOST study findings, extended follow-up from the initial canaloplasty cohort, and further CREST analyses are expected to contribute to the evidence base for the company's bio-interventional glaucoma surgery portfolio.

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CooperVision Highlights Global Partnerships Expanding Access to Eye Care on World Sight Day https://eyewire.news/news/coopervision-highlights-global-partnerships-expanding-access-to-eye-care-on-world-sight-day Thu, 08 Oct 2026 13:40:14 GMT https://eyewire.news/news/coopervision-highlights-global-partnerships-expanding-access-to-eye-care-on-world-sight-day Key Takeaways

  • CooperVision's global eye care partnerships now span more than 85 countries, involving over 600 academic institutions, thousands of ECPs, and millions of individuals.

  • Collaborations with organizations including the International Agency for the Prevention of Blindness, The Myopia Collective, and Optometry Giving Sight focus on advocacy, childhood myopia awareness, education, and professional development.

In recognition of World Sight Day 2026, CooperVision announced the global reach of its partnerships aimed at expanding access to eye care through advocacy, education, policy initiatives, and community-based programs.

According to the company, these collaborative efforts now extend across more than 85 countries and involve more than 600 academic institutions, thousands of eye care professionals (ECPs), and millions of individuals worldwide.

"Improving access to quality vision care requires collaboration across the eye care ecosystem," said Jennifer Palombi, OD, FAAO, director of professional affairs–Americas at CooperVision. "Whether through advocacy, education, policy initiatives, or community-based programs, meaningful progress happens when organizations work together toward a common goal. We're proud to support partnerships that help expand access to vision services and improve eye health outcomes for people around the world."

CooperVision's partnerships address several global eye health priorities, including preventable vision impairment, access to vision services, and childhood myopia.

The company works with organizations including the International Agency for the Prevention of Blindness, the Healthcare Alliance for Patient Safety, and The Myopia Collective to support awareness and advocacy efforts.

These collaborations seek to increase attention to avoidable vision loss and the importance of early identification and management of myopia, particularly among children. By engaging organizations involved in eye health policy and advocacy, CooperVision aims to support broader efforts to improve access to appropriate vision care services.

Education and workforce development represent another component of CooperVision's global partnerships. Through collaborations with the International Association of Contact Lens Educators and Optometry Giving Sight (OGS), the company supports initiatives intended to strengthen eye care education and professional development.

These efforts focus on preparing future generations of ECPs and supporting the knowledge and skills needed to deliver quality vision care.

The involvement of more than 600 academic institutions underscores the educational reach of the company's collaborative initiatives.

Beyond advocacy and professional education, CooperVision supports community-based programs intended to bring essential eye care services to underserved populations. The company identified Vision Action, the African Eye Institute, the Indian Eye Institute, Plastic Bank, and OGS among the organizations involved in these efforts. The initiatives include the delivery of vision screenings, an important component of identifying individuals who may require additional eye examinations or treatment.

Community-based approaches can help address barriers to care by connecting individuals with vision services and increasing awareness of the importance of regular eye examinations.

World Sight Day, observed October 8 in 2026, provides an opportunity to highlight global efforts to prevent avoidable vision impairment and improve access to eye health services.

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Glaukos Reports 3-year Epioxa Data Showing Sustained Corneal Flattening in Keratoconus https://eyewire.news/news/glaukos-reports-3-year-epioxa-data-showing-sustained-corneal-flattening-in-keratoconus Wed, 07 Oct 2026 20:58:24 GMT https://eyewire.news/news/glaukos-reports-3-year-epioxa-data-showing-sustained-corneal-flattening-in-keratoconus Key Takeaways

  • Eyes treated with Epioxa maintained a 1.9-D improvement in Kmax from baseline at 3 years without additional cross-linking intervention during the extension period
  • At year 3, 29% of treated eyes had gained at least 2 lines of BCVA and 20% had gained at least 3 lines
  • No serious adverse events, treatment-related adverse events, or discontinuations due to adverse events were reported through 3 years in the extension study

Glaukos announced positive topline results from a long-term phase 3 extension study of Epioxa, its investigational epi-on corneal cross-linking therapy for keratoconus, reporting sustained improvements in corneal curvature and visual acuity through 3 years after a single treatment.

Results from the GLK-202-03 extension study showed that treated eyes maintained a 1.9-diopter (D) improvement from baseline in maximum corneal curvature (Kmax) at 3 years. No additional cross-linking intervention was performed during the extension period, according to the company.

Visual acuity improvements were also observed at year 3. Among treated eyes, 29% gained at least 2 lines of best-corrected visual acuity (BCVA) from baseline, while 20% gained at least 3 lines.

“These long-term results further reinforce the potential of Epioxa to provide durable clinical benefits for patients living with keratoconus,” Thomas Burns, chairman and CEO of Glaukos, said in a news release. “The sustained improvements in corneal shape and visual acuity, coupled with an excellent long-term safety profile, reinforce our view that Epioxa represents a transformative treatment advancement for keratoconus patients.”

GLK-202-03 was designed to evaluate the long-term safety, durability, and clinical outcomes of patients who completed the phase 3 GLK-202-02 pivotal trial and received corneal cross-linking during that study. A total of 38 study eyes from 35 patients participated in the extension, with 92% of eyes completing the year 3 visit. Efficacy assessments focused on changes in corneal curvature and visual acuity.

According to Glaukos, the sustained 1.9-D improvement in Kmax indicates continued corneal flattening and stabilization 3 years after treatment.

The company also reported a favorable long-term safety profile. Through 3 years, there were no serious adverse events, treatment-related adverse events, or discontinuations due to adverse events among treated eyes participating in the extension study.

Epioxa is designed to treat keratoconus without removing the corneal epithelium, differentiating the therapy from conventional epithelium-off, or epi-off, corneal cross-linking.

The investigational treatment uses an oxygen-supplemented topical therapy that is bioactivated with pulsed ultraviolet light. By preserving the corneal epithelium, the approach is intended to reduce procedure-related pain and recovery associated with epithelial removal while providing corneal stabilization.

The new findings add longer-term follow-up to the efficacy and safety data generated in the GLK-202-02 pivotal trial. Glaukos said the durability observed through 3 years supports the potential for a single Epioxa treatment to provide sustained disease stabilization in patients with keratoconus.

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Bausch + Lomb to Present IOL, Glaucoma and Ocular Surface Data at AAO https://eyewire.news/news/bausch-lomb-to-present-iol-glaucoma-and-ocular-surface-data-at-aao Wed, 07 Oct 2026 15:04:42 GMT https://eyewire.news/news/bausch-lomb-to-present-iol-glaucoma-and-ocular-surface-data-at-aao Key Takeaways

  • Bausch + Lomb's AAO 2026 scientific program includes research involving IOLs, glaucoma procedures, and treatments for dry eye disease
  • Studies will examine outcomes with small-aperture and enhanced monofocal IOLs, excimer laser trabeculostomy, lifitegrast, and perfluorohexyloctane ophthalmic solution
  • The company will also host educational programs addressing advanced IOL selection, ocular surface management, and integration of surgical technologies into cataract practices

Bausch + Lomb announced plans to present new scientific data spanning cataract surgery, glaucoma, and ocular surface disease at the American Academy of Ophthalmology (AAO) 2026 annual meeting, taking place October 9-12 in New Orleans.

The company's scientific program includes research evaluating the enVista Aspire and IC-8 Apthera IOLs, Xiidra, Miebo, and the Elios procedure for glaucoma. Bausch + Lomb will also host educational programs focused on incorporating its ocular surface and surgical products into clinical practice.

Among the research being presented are studies examining outcomes with enhanced monofocal and small-aperture IOLs, the use of minimally invasive glaucoma surgery (MIGS) in conjunction with cataract surgery, and real-world and prospective findings involving treatments for dry eye disease.

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

Thursday, October 8, 2026 
Integrating Bausch + Lomb's IOLs into Your Advanced Lenses Business

  • 7:15pm CT, Calcasieu, 930 Tchoupitoulas Street
  • Speakers: Alison Early, MD and Jonathan Lam, MD
  • Click here to register for this event

Friday, October 9, 2026 
The Frontline of Modern Cataract Surgery: Ocular Surface Health and Advanced IOL Selection

  • 7:00pm CT, The National WWII Museum, 1043 Magazine Street
  • Speakers: Brandon Ayres, MD and Jai Parekh, MD
  • Consistent evaluation and management of the ocular surface are important considerations when planning cataract surgery with advanced technology IOLs. This case-based program will explore clinical approaches to patient assessment, preoperative planning and patient selection, with strategies intended to help maximize visual potential and patient satisfaction. The discussion will also highlight how Bausch + Lomb's portfolio of ocular surface and surgical products may be incorporated into practice to help support decision-making across the cataract surgery continuum.
  • Click here to register for this event

Saturday, October 10, 2026 
Integrating Bausch + Lomb's IOLs into Your Advanced Lenses Business

  • 7:15pm CT, Arnaud's, 813 Rue Bienville
  • Speakers: Michael Patterson, DO and Zaina Al-Mohtaseb, MD
  • Click here to register for this event

Poster Presentations

  • "Reduced medication burden with maintained visual and structural stability after MIGS procedure in cataract surgery." Sarkisian S.
  • "Outcomes of small-aperture intraocular lens in patients with prior corneal refractive surgery or corneal comorbidities." Stonecipher K.

Posters

  • "Understanding Robust Responders to Lifitegrast in Dry Eye Disease: A Qualitative Study of Eye Care Providers." Donnenfeld E.
  • "24-month outcomes of excimer laser trabeculostomy in patients with open angle glaucoma undergoing cataract surgery." Gallardo M.
  • "Concomitant use of Perfluorohexyloctane Ophthalmic Solution With Contact Lens Wear: A Prospective Open-Label Study." Mah F.
  • "Characteristics of Patients With Improved Tear Film Break-Up Time on Lifitegrast Treatment in a Real-World Setting." Nijm L.
  • "Visual and refractive outcomes following implantation of an enhanced monofocal intraocular lens: A Real-World Study." Sadri E.

Additionally, Bausch + Lomb is sponsoring a number of events at the meeting, including Eyecelerator @ AAO and its Winning Pitch Challenge, AAO's Illuminate the Night event, COBRA After Dark Surgical Retina Rounds, the OWL Signature Event & Awards Ceremony, the Women in Ophthalmology 2026 Awards & Reception, Real World Ophthalmology "After Dark" and the Innovators Pop-Up "Moments of Wonder" event.

Bausch + Lomb is also partnering with YoungMD Connect (YMDC) as a supporter of their 2026 Capstone Event, and hosting groups of YMDC members at the booth for leadership meetings and tours throughout the meeting.

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Atsena Reports Preliminary ATSN-201 Results in X-linked Retinoschisis https://eyewire.news/news/atsena-reports-preliminary-atsn-201-results-in-x-linked-retinoschisis Wed, 07 Oct 2026 14:36:35 GMT https://eyewire.news/news/atsena-reports-preliminary-atsn-201-results-in-x-linked-retinoschisis Key Takeaways

  • Six of 9 patients receiving the ATSN-201 dose selected for phase 3 met the microperimetry response criterion, while 7 of 9 responded on microperimetry and/or visual acuity
  • ATSN-201 demonstrated a favorable preliminary safety profile in Parts A and B, with no drug-related serious adverse events or dose-limiting toxicities reported
  • Atsena expects to complete enrollment in the pivotal phase 3 portion of LIGHTHOUSE by the end of Q1 2027, with topline results anticipated in the first half of 2028

Atsena Therapeutics reported preliminary safety and efficacy findings for its investigational gene therapy ATSN-201 in patients with X-linked retinoschisis (XLRS), with 6 of 9 patients treated at the dose selected for phase 3 meeting the study's microperimetry response criterion.

The findings from Parts A and B of the phase 1/2/3 LIGHTHOUSE Study are being presented at the American Academy of Ophthalmology (AAO) 2026 Annual Meeting, held October 9 to 12 in New Orleans.

Atsena is advancing the 1.1E10 vg/eye dose into Part C, the pivotal phase 3 portion of LIGHTHOUSE. The company said enrollment is expected to be completed by the end of the first quarter of 2027, with topline results anticipated in the first half of 2028.

“Data presented this week at AAO and last week at the American Academy of Optometry annual meeting show that ATSN-201 has the potential to provide clinically meaningful benefit to patients with XLRS,” Kenji Fujita, MD, chief medical officer of Atsena Therapeutics, said in a news release.

According to Dr. Fujita, the majority of patients treated at the pivotal dose achieved microperimetry improvements exceeding 7 dB across at least 5 loci, an outcome the company said the FDA has identified as supportive of approval. Improvements in retinal structure and visual acuity were also reported.

Phase 1/2 findings

Thomas S. Aleman, MD, of the Scheie Eye Institute and Children's Hospital of Philadelphia, presented 12-month safety and efficacy findings for adult participants and 6-month findings for pediatric participants enrolled in Parts A and B of LIGHTHOUSE.

ATSN-201 was administered by subretinal injection to 1 eye per patient. Parts A and B enrolled 21 patients overall, including 18 who received treatment—15 adults and 3 pediatric patients—and 3 untreated adult controls.

Part A evaluated 3 ATSN-201 doses in cohorts of 3 adults each. Part B assessed 2 dose volumes in adult cohorts, along with an untreated adult control cohort and a pediatric cohort treated at the lower volume.

According to Atsena, ATSN-201 demonstrated a favorable safety profile across participants, with no drug-related serious adverse events or dose-limiting toxicities reported.

Efficacy assessments included foveal schisis closure on optical coherence tomography (OCT), microperimetry, best-corrected visual acuity (BCVA), and low-luminance visual acuity (LLVA).

Microperimetry response, which serves as the primary endpoint for the pivotal phase 3 portion of LIGHTHOUSE, was defined as an average improvement of at least 7 dB across central qualifying loci. Visual acuity response was defined as an improvement of at least 10 letters in either BCVA or LLVA.

Investigators observed structural and functional responses at each of the 3 doses evaluated in Part A. The lowest dose, 1.1E10 vg/eye, was selected for phase 3 based on what the company described as consistent efficacy and more favorable tolerability compared with the higher doses.

Among the 9 patients treated at the pivotal dose across Parts A and B, 7 demonstrated a response on at least 1 of the 2 visual function measures: microperimetry or visual acuity.

Six of 9 patients met the microperimetry response criterion, 5 of 9 were OCT responders, and 3 of 9 were visual acuity responders. None of the 9 untreated fellow eyes met response criteria for OCT, microperimetry, or visual acuity, according to the company.

Across all 18 treated patients in Parts A and B, 13 demonstrated a response on at least 1 visual function measure. Twelve were OCT responders, 9 were microperimetry responders, and 9 were visual acuity responders.

Among the 18 untreated fellow eyes, 1 met the microperimetry response criterion and 1 was a visual acuity responder; none were OCT responders. Among the 3 untreated control patients, none were OCT or microperimetry responders, while 1 met the visual acuity response criterion.

Visual acuity and durability findings

A separate analysis examined BCVA among the 8 of 9 pivotal-dose patients whose baseline visual acuity was worse than 20/40. At their most recent assessments, 3 had achieved visual acuity of 20/40 or better, which the company noted is a threshold commonly associated with driving eligibility in the United States.

Of the remaining 5 patients, 3 showed improvement in visual acuity and 2 remained unchanged from baseline. Atsena also reported longer-term findings from the earliest-treated patient receiving the pivotal dose. That patient reached 3 years of follow-up in July 2026 after a single administration of ATSN-201.

At 36 months, the patient's foveal schisis remained closed, while improvements of 12 dB in microperimetry, 19 letters in BCVA, and 22 letters in LLVA were maintained, according to the company.

“These results give us confidence in the dose now advancing through Part C, the pivotal Phase 3 portion of the LIGHTHOUSE Study,” Dr. Fujita said.

Part C enrollment is expected to conclude by the end of the first quarter of 2027. Atsena anticipates topline phase 3 results in the first half of 2028 and said the data could support a potential biologics license application filing in the second half of 2028.

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Study Links GLP-1 Use to Earlier Fellow-Eye NAION Involvement https://eyewire.news/news/study-links-glp-1-use-to-earlier-fellow-eye-naion-involvement Wed, 07 Oct 2026 14:15:36 GMT https://eyewire.news/news/study-links-glp-1-use-to-earlier-fellow-eye-naion-involvement Key Takeaways

  • Among patients who developed bilateral NAION, 56.8% of second-eye events in GLP-1 users occurred within 6 months, compared with 40.6% among nonusers
  • The retrospective database study identifies an association and cannot establish that GLP-1 medications cause earlier fellow-eye involvement
  • Researchers said ophthalmologists should consider GLP-1 use when taking medication histories and counseling patients after a first-eye NAION event, while recognizing the systemic benefits of the drugs

Patients taking GLP-1 medications who develop nonarteritic anterior ischemic optic neuropathy (NAION) in both eyes may experience involvement of the fellow eye sooner than patients who are not taking the drugs, according to research presented at the 130th annual meeting of the American Academy of Ophthalmology (AAO).

The study found that among patients who developed bilateral NAION, 56.8% of second-eye events in GLP-1 users occurred within 6 months of the initial event, compared with 40.6% among patients who were not taking GLP-1 medications.

NAION occurs when insufficient blood flow to the optic nerve results in sudden, painless vision loss, typically in one eye. Although the fellow eye can eventually become affected, rapid sequential involvement is less common.

“Approximately 15% of patients will develop NAION in the fellow eye within 5 years after a diagnosis in the first eye,” said Ashley Tin, a study co-author and medical student at Carle Illinois College of Medicine. “Rapid, sequential involvement of the second eye is typically less common.”

The study grew out of a clinical observation by co-author Matthew D. Kay, MD, who noticed several patients presenting over a relatively short period with NAION affecting both eyes in rapid succession—and, in some cases, simultaneously. The patients were taking GLP-1 agonists.

“The apparent increase in rapidly sequential presentations seemed unusual and prompted us to investigate whether this pattern could also be seen in a large national database,” Dr. Tin said.

Investigators used Epic Cosmos, a large repository of electronic health records, to examine second-eye NAION events recorded between 2015 and 2025.

The analysis included approximately 1,440 GLP-1 users and 20,700 patients who were not taking the medications. Researchers examined the timing of fellow-eye involvement following the initial NAION event, ranging from 1 month to 5 years.

Among GLP-1 users who developed bilateral disease, 56.8% of second-eye events occurred within 6 months, compared with 40.6% in the non-GLP-1 group. In the researchers’ statistical model, the shift toward earlier rather than later second-eye events was approximately 1.98 times as strong among GLP-1 users. Investigators reported that the pattern was observed both before and after GLP-1 medications came into widespread use.

“We were not particularly surprised by the findings because the large-database analysis was consistent with the clinical observation that prompted the study,” Dr. Tin said. “That said, seeing the clinical impression reproduced across a very large dataset was striking and underscored the need to investigate the association further.”

Findings do not establish causation

The researchers cautioned that the study identifies an association and does not establish that GLP-1 medications cause earlier fellow-eye NAION.

Patients taking GLP-1 medications had average hemoglobin A1C levels 1.0 to 1.4 percentage points higher than patients who were not taking the drugs. The difference raises the possibility that diabetes severity or other underlying health factors could contribute to the observed association.

The use of aggregated rather than individual patient-level data also limited researchers’ ability to control for potential confounding factors.

For ophthalmologists, Dr. Tin said the findings support including GLP-1 use when obtaining a medication history from patients with NAION and considering it when counseling patients following a first-eye event.

“GLP-1 use should be an important part of the medication history in patients presenting with NAION, particularly when counseling patients after a first-eye event,” Dr. Tin said, adding that treatment decisions “should continue to consider the substantial systemic benefits of these medications.”

Patients should not discontinue GLP-1 therapy on the basis of the findings, she emphasized.

“These drugs have important benefits for diabetes, obesity and cardiovascular health, and our study identifies an association rather than proving that the medications cause NAION,” Dr. Tin said.

The AAO and the North American Neuro-Ophthalmology Society have also issued guidance addressing current evidence surrounding GLP-1 medications and vision loss.

Further research will be needed to determine whether the observed pattern is related to GLP-1 therapy itself or to underlying characteristics of patients who use the medications. Studies using detailed patient-level data could account for diabetes severity and other vascular conditions while examining specific GLP-1 agents, doses, duration of treatment, and the timing of therapy relative to NAION events.

Ultimately, prospective studies will be needed to determine whether the association is causal, according to Dr. Tin.

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Volk Optical Launches ClearField Pro Lens for Retinal Examination and Laser Treatment https://eyewire.news/news/volk-optical-launches-clearfield-pro-lens-for-retinal-examination-and-laser-treatment Wed, 07 Oct 2026 11:38:00 GMT https://eyewire.news/news/volk-optical-launches-clearfield-pro-lens-for-retinal-examination-and-laser-treatment Key Takeaways 

  • Volk Optical has launched ClearField Pro for retinal examination and laser indirect ophthalmoscopy
  • The lens incorporates redesigned aspheric optics and an anti-reflective coating intended to improve retinal visualization across LED illumination and multiple laser wavelengths
  • ClearField Pro is 10% lighter than comparable lenses and includes a precision-milled grip and fingerprint-resistant oleophobic topcoat

Volk Optical announced the launch of ClearField Pro, a new ophthalmic lens designed for retinal examination and laser indirect ophthalmoscopy.

According to the company, the lens combines redesigned aspheric optics, advanced coatings, and a lighter design to support retinal visualization during diagnostic examinations and laser treatment.

ClearField Pro features an advanced anti-reflective coating that provides up to 77% less reflectivity, according to Volk. The coating is designed for low reflectance under LED illumination as well as green, yellow, and infrared laser treatment wavelengths.

The company said the lens's redesigned aspheric optics are intended to provide clear visualization of peripheral retinal detail while reducing image distortion. The lens is also designed to maintain visualization in patients with small pupils.

For handling, ClearField Pro is 10% lighter than comparable lenses, according to Volk, and incorporates a precision-milled grip. An oleophobic topcoat is designed to resist fingerprints and oils, helping reduce smudging and facilitate cleaning.

“Clinicians need a clear view whether they are examining the retina or delivering laser treatment,” Ali Salo, chief commercial officer of Volk Optical, said in the release. “ClearField Pro brings those needs together in one lens, with purpose-built coatings and practical refinements to its optics and handling.”

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2026 Nobel Prize in Medicine Recognizes Optogenetics Pioneers https://eyewire.news/news/2026-nobel-prize-in-medicine-recognizes-optogenetics-pioneers Tue, 06 Oct 2026 20:59:16 GMT https://eyewire.news/news/2026-nobel-prize-in-medicine-recognizes-optogenetics-pioneers Key Takeaways

  • Karl Deisseroth, Peter Hegemann, and Georg Nagel received the 2026 Nobel Prize in Physiology or Medicine for discoveries involving light-gated ion channels and optogenetics
  • The technology grew from the discovery of channelrhodopsin, an algal protein that can make cells responsive to light, into a method for controlling neural activity
  • Optogenetic approaches are being investigated in clinical medicine as a potential strategy for restoring sight in people with visual impairment

The 2026 Nobel Prize in Physiology or Medicine has been awarded jointly to Karl Deisseroth, MD, PhD, Peter Hegemann, PhD, and Georg Nagel, PhD, for discoveries that established optogenetics, a technology that has transformed neuroscience and is being investigated as a potential approach for restoring vision in patients with visual impairment.

The Nobel Assembly at Karolinska Institutet recognized the 3 scientists “for their discoveries concerning light-gated ion channels and optogenetics.”

Dr. Hegemann, of Humboldt University of Berlin, Germany, and Dr. Nagel, of the University of Würzburg, Germany, discovered channelrhodopsin, a light-sensitive protein found in the single-celled alga Chlamydomonas. Dr. Deisseroth, of the Howard Hughes Medical Institute and Stanford University, subsequently developed the discovery into a method for controlling nerve-cell activity with light.

The work ultimately provided researchers with a tool capable of selectively activating neurons, opening new avenues for investigating the neural circuits underlying behavior, memory, emotion, and disease. In ophthalmology, the same fundamental principle is being explored as a strategy for restoring light sensitivity in patients with impaired vision.

From algae to light-controlled neurons

The discoveries originated with research into how Chlamydomonas moves toward a source of light.

In the early 2000s, Drs. Hegemann and Nagel identified channelrhodopsin, a protein on the surface of the algal cell with an unusual response to illumination. Exposure to blue light causes a channel within the protein to open, allowing charged ions to enter the cell and produce an electrical impulse. Importantly, the researchers found that introducing the protein into other types of cells could make those cells sensitive to light.

Dr. Deisseroth subsequently introduced the gene encoding channelrhodopsin into rat nerve cells. When the cells were exposed to blue light, he was able to trigger a neural signal. The breakthrough was published in 2005. By 2007, Dr. Deisseroth had demonstrated that the light-controlled approach could function in the brains of living mice.

The technique became known as optogenetics and rapidly developed into a widely used neuroscience research tool.

“Optogenetics provides opportunities for mapping the brain in a way that we could once only dream of,” Per Svenningsson, chair of the Nobel Committee for Physiology or Medicine, said in announcing the prize.

Relevance to ophthalmology

Although much of optogenetics research has focused on understanding the brain, the technology also has important implications for vision science.

Optogenetic strategies are being investigated as a means of restoring visual function in individuals with visual impairment. The concept builds on the ability of light-sensitive proteins to confer photosensitivity on cells that ordinarily do not respond directly to light.

That capability is particularly relevant to efforts to develop new approaches for patients in whom the eye's natural light-sensing mechanisms have been compromised.

Rather than relying solely on surviving photoreceptors to initiate a visual signal, optogenetic approaches offer the possibility of making other surviving cells within the visual pathway responsive to light. In principle, those cells could then generate signals in response to visual stimuli and transmit information through remaining neural circuitry.

The Nobel recognition underscores the decades-long path from a basic biological question about how an alga responds to light to a technology now being explored for clinical applications, including vision restoration.

Establishing cause and effect in neural circuits

Optogenetics has also addressed a longstanding challenge in neuroscience: determining causal relationships between the activity of specific nerve cells and particular functions.

Earlier approaches allowed researchers to associate regions of the brain with behaviors or physiological processes, but establishing precisely how particular populations of neurons produced those effects remained difficult.

By genetically introducing light-sensitive proteins into selected cells and controlling their activity with light, investigators gained a method for manipulating specific neural populations with high temporal precision.

Researchers have subsequently used optogenetics to investigate circuits involved in memories, emotions, behaviors, and processes associated with neurological and psychiatric disorders.

For ophthalmology and vision science, the technology provides both a research platform for investigating visual circuitry and a potential therapeutic principle for restoring light responsiveness when normal photoreceptor function has been lost.

The 2026 Nobel Prize recognizes the sequence of discoveries that made that capability possible: the identification and characterization of channelrhodopsin by Drs. Hegemann and Nagel and Deisseroth's development of the protein into a practical tool for controlling neurons.

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Sight Sciences Launches Omni Ultra Surgical System for Implant-Free Glaucoma Intervention https://eyewire.news/news/sight-sciences-launches-omni-ultra-surgical-system-for-implant-free-glaucoma-intervention Tue, 06 Oct 2026 16:26:36 GMT https://eyewire.news/news/sight-sciences-launches-omni-ultra-surgical-system-for-implant-free-glaucoma-intervention Key Takeaways

  • Sight Sciences has commercially launched Omni Ultra, its next-generation implant-free ab interno canaloplasty system for adult patients with primary open-angle glaucoma
  • Omni Ultra enables single-pass canaloplasty followed by trabeculotomy and incorporates TruSync Plus technology and enhanced catheter visualization
  • Sight Sciences will feature Omni Ultra and preview the Clearance Assistant Plus for the TearCare System during AAO 2026 in New Orleans

Sight Sciences announced the commercial availability of the Omni Ultra Surgical System, the latest generation of its ab interno canaloplasty platform for the treatment of primary open-angle glaucoma (POAG).

The company will feature Omni Ultra at the 2026 American Academy of Ophthalmology (AAO) annual meeting, taking place October 9-12 in New Orleans.

Omni Ultra builds on the company's existing Omni Surgical System and is designed to provide surgeons with additional procedural flexibility and control while maintaining an implant-free approach to minimally invasive glaucoma surgery (MIGS).

“I have relied on the Omni Surgical System for 8 years now and can still appreciate how Omni Ultra builds on a proven technology platform with even more versatility and procedural flexibility,” Zarmeena Vendal, MD, cataract and glaucoma surgeon and owner of Westlake Eye Specialists, said in a statement. Vendal was a prelaunch user of the technology.

According to Vendal, the additional flexibility could help address the needs of a broader range of surgeons as adoption of interventional glaucoma procedures grows.

The Omni technology platform received an expanded FDA glaucoma clearance in 2021. The new Omni Ultra system enables single-pass canaloplasty followed by trabeculotomy and incorporates TruSync Plus technology and enhanced catheter visualization.

The system is designed to reduce IOP by addressing the 3 recognized areas of resistance within the conventional aqueous outflow pathway: the trabecular meshwork, Schlemm's canal, and collector channels.

Omni Ultra can be used as a standalone procedure or in combination with cataract surgery in adult patients with POAG.

Key features of Omni Ultra include:

  • Comprehensive implant-free intervention: The system addresses the trabecular meshwork, Schlemm's canal, and collector channels through a single clear corneal microincision without leaving an implant behind.
  • Single-pass canaloplasty: Omni Ultra accesses the full circumference of Schlemm's canal with a single pass for canaloplasty followed by trabeculotomy.
  • TruSync Plus technology: The technology provides automatic viscodilation of Schlemm's canal during both advancement and retraction of the microcatheter during canaloplasty.
  • Expanded treatment versatility: The system is designed to support customized treatment across different disease severities and surgical settings, with enhanced catheter visualization intended to help surgeons assess and tailor treatment delivery.

Sight Sciences will also use AAO 2026 to preview Clearance Assistant Plus for its TearCare System. The dual-action tool is designed to perform both meibomian gland expression and eyelid debridement. The technology is part of the company's interventional dry eye portfolio.

Sight Sciences plans AAO events and demonstrations

Sight Sciences will showcase Omni Ultra, TearCare, and other technologies at booth 1237 during AAO. The company also plans several events surrounding the meeting:

  • ASOA Live! IG Dinner Series: October 8 from 6:30 pm to 8:30 pm at Tableau in New Orleans. The case-based program will examine real-world adoption of interventional glaucoma across 3 practices
  • TearCare Clearance Experience Sessions: October 10 and 11, with sessions from 9 am to 10 am, noon to 1 pm, and 3 pm to 4 pm. The programs will include live TearCare demonstrations at booth 1237 and discussions about incorporating the technology into clinical practice
  • IX Eyecon Appreciation Reception: October 10 from 6 pm to 8 pm at Sazerac House in New Orleans. The event will recognize participating clinicians and provide a preview of Sight Sciences' newest technologies

Attendees can also visit booth 1237 during exhibit hours for demonstrations of technologies across the company's interventional glaucoma and dry eye portfolios.

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Topcon Announces Global Launch of Oku Digital Health to Connect Ocular Data with Systemic Disease Insights https://eyewire.news/news/topcon-healthcare-launches-oku-digital-health-to-connect-ocular-data-with-systemic-disease-insights Tue, 06 Oct 2026 16:05:22 GMT https://eyewire.news/news/topcon-healthcare-launches-oku-digital-health-to-connect-ocular-data-with-systemic-disease-insights Key Takeaways

  • Topcon Healthcare has launched Oku Digital Health, an AI-powered company focused on using ocular data to support disease detection, referrals, and pharmaceutical research
  • Oku combines AI-supported diagnostics, EHR integration, and referral workflows and will operate across a network of more than 10,000 care locations, according to the company
  • Oku will make its industry debut at AAO 2026 in New Orleans, with its solutions featured within the Topcon Healthcare exhibit

Topcon Healthcare announced the global launch of Oku Digital Health, an artificial intelligence-powered company designed to use data generated through routine eye care to support earlier disease detection, clinical referrals, and pharmaceutical research.

Oku combines AI-supported diagnostics, electronic health record integration, and referral workflows in an effort to connect eye care with primary care and other medical specialties. The company is also targeting pharmaceutical applications, including the use of patient data and real-world evidence in drug development and precision medicine.

The launch builds on the emerging field of oculomics, which uses ocular imaging and other eye-derived data to identify biomarkers associated with systemic health.

“The eye is becoming the front door to medicine, but a front door only matters if it leads somewhere,” Ali Tafreshi, CEO of Oku Digital Health, said in a statement. “Oku puts what the eye reveals in the hands of those who can act on it; clinicians and researchers across eye care, primary care, and drug development.”

Advances in AI and oculomics are expanding researchers' ability to analyze ocular data for signals associated with systemic diseases. According to Oku, measurable changes in the eye may be associated with conditions including cardiovascular and kidney disease. The company aims to translate those insights into clinical workflows that can facilitate earlier intervention and disease management.

Built on Topcon Healthcare's existing infrastructure, Oku will operate across a connected network of more than 10,000 care locations, according to the company.

For healthcare providers, the platform is intended to connect primary care clinicians, optometrists, ophthalmologists, and other specialists through diagnostic, EHR, and referral capabilities.

For pharmaceutical companies, Oku plans to provide data and real-world evidence that can support clinical development and precision medicine programs.

“Topcon Healthcare is synonymous with the diagnostic solutions optometrists and ophthalmologists rely on every day,” Lance Patton, president of Topcon Healthcare, said in a statement. “Over the past 5 years, we strategically invested in software, clinical decision support, and AI to achieve our Healthcare from the Eye vision.”

Patton said bringing those capabilities together under Oku represents an expansion of that strategy.

Oku's founding leadership team includes executives with backgrounds spanning ophthalmology, artificial intelligence, healthcare technology, and pharmaceutical development.

Mr. Tafreshi will serve as CEO while remaining chief strategy officer for Topcon Corp.'s Eyecare Business Division and CEO of Topcon Healthcare. He previously served as global head and vice president of product management and clinical affairs at Heidelberg Engineering.

Trent Norris, Oku's chief operating officer, previously served as global head of business development for digital health at Nvidia and held roles at Flywheel.io and Microsoft.

Matthew Lungren, MD, MPH, has been appointed chief data AI officer. Dr. Lungren is also an adjunct professor of biomedical data science at Stanford University School of Medicine and previously served as chief scientific officer at Microsoft Health and Life Sciences.

Daniela Ferrara, MD, PhD, FASRS, FARVO, will serve as chief medical officer. She is an assistant professor of ophthalmology at Tufts University School of Medicine and previously spent nearly 11 years at Genentech, where she became principal medical director of ophthalmology.

Jacques Gilbert will serve as chief strategy and business development officer. His previous experience includes serving as vice president of healthcare strategy, partnerships, and M&A at Microsoft, as well as positions at Nuance Communications and GE Healthcare.

Oku will make its industry debut during the 2026 American Academy of Ophthalmology Annual Meeting in New Orleans, scheduled for October 9-12. The company will showcase its provider and pharmaceutical solutions within the Topcon Healthcare exhibit at booth 1737.

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Alcon to Showcase Surgical, Retinal, Glaucoma, and Dry Eye Innovations at AAO https://eyewire.news/news/alcon-to-showcase-surgical-retinal-glaucoma-and-dry-eye-innovations-at-aao Tue, 06 Oct 2026 15:38:41 GMT https://eyewire.news/news/alcon-to-showcase-surgical-retinal-glaucoma-and-dry-eye-innovations-at-aao Key Takeaways

  • Alcon will feature technologies across cataract surgery, retina, glaucoma, and dry eye disease at AAO 2026 in New Orleans
  • The Unity surgical platform and new Unity M ophthalmic microscope will anchor the company's surgical technology demonstrations
  • Other featured products include Clareon PanOptix Pro and Clareon TruPlus IOLs, Valeda PBM for dry AMD, Voyager DSLT for glaucoma, and Tryptyr for dry eye disease

Alcon will highlight technologies across cataract surgery, retina, glaucoma, and dry eye disease during the 2026 American Academy of Ophthalmology (AAO) annual meeting, taking place October 10-12 in New Orleans.

The company's exhibit will feature hands-on demonstrations of several technologies, including the Unity surgical platform and new Unity M ophthalmic microscope, Clareon PanOptix Pro and Clareon TruPlus IOLs, Valeda photobiomodulation (PBM), and Voyager DSLT.

“At AAO 2026, Alcon will demonstrate how innovation is redefining what’s possible in eye care,” Sergio Duplan, president of the Americas at Alcon, said in a statement. “Attendees will experience firsthand how our portfolio is helping shape the future of eye care through technologies and clinical solutions that support eye care professionals every day.”

Unity platform to anchor surgical demonstrations

The Unity platform will serve as a centerpiece of Alcon’s presence at the meeting, with attendees able to participate in demonstrations of its 2 configurations: the Unity VCS combined console and Unity CS standalone cataract system.

Alcon will also feature the recently launched Unity M ophthalmic microscope, which is designed to provide ophthalmic surgeons with precise control during procedures.

Together, the technologies are intended to support surgical visualization, workflow efficiency, and performance. Alcon said its representatives will offer one-on-one discussions and product demonstrations throughout the meeting.

Clareon portfolio expands cataract surgery offerings

In cataract surgery, Alcon will highlight Clareon PanOptix Pro, the latest addition to its trifocal IOL portfolio.

The company will also feature Clareon TruPlus IOLs, its next-generation monofocal and toric IOL platform. According to Alcon, the platform is designed to build on the performance of the existing Clareon family.

Valeda targets early and intermediate dry AMD

For retina specialists, Alcon will demonstrate the Valeda PBM system, an FDA-authorized treatment for patients with early and intermediate dry age-related macular degeneration (AMD).

The noninvasive technology uses photobiomodulation to deliver specific wavelengths of light to ocular tissue. Alcon will provide dedicated demonstrations of the technology during the meeting.

Voyager DSLT offers automated laser treatment for glaucoma

Alcon will also showcase Voyager DSLT as part of its glaucoma portfolio. The system uses automated SureTrac eye-tracking technology to deliver laser pulses through the limbus to the trabecular meshwork. The company is positioning the technology as a first-line treatment option for patients with glaucoma.

Tryptyr highlighted for dry eye disease

Beyond its surgical and device portfolio, Alcon will feature Tryptyr (acoltremon ophthalmic solution) 0.003% for the treatment of dry eye disease.

Tryptyr is a neuromodulator eye drop designed to stimulate natural tear production. According to Alcon, the therapy can increase natural tear production beginning on the first day of treatment. The company plans to provide information at its exhibit about the treatment's mechanism of action and its role in dry eye disease management.

Attendees can explore Alcon's technologies and demonstrations at booth 1519 during AAO 2026.

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Zeiss to Highlight Ophthalmic Workflow Innovations, Technology Milestones at AAO https://eyewire.news/news/zeiss-to-highlight-ophthalmic-workflow-innovations-technology-milestones-at-aao Tue, 06 Oct 2026 14:52:45 GMT https://eyewire.news/news/zeiss-to-highlight-ophthalmic-workflow-innovations-technology-milestones-at-aao Key Takeaways

  • Zeiss will showcase technologies spanning cataract, refractive, retina, glaucoma, surgical visualization, and digital clinical workflows at AAO 2026
  • The company reported major adoption milestones, including 3 million cases planned with Veracity Surgery Planner, more than 15 million eyes treated with Smile and Smile pro, and more than 1 million US procedures using DORC TissueBlue
  • New and updated offerings at the meeting include the HMDmd CR3 head-mounted display, Atlas 500 enhancements, VisioGen updates, the Matrix-VR headset perimeter under development, and the recently FDA-cleared Clinic 360 platform

Zeiss will showcase a range of ophthalmic technologies spanning cataract, corneal refractive, retina, glaucoma, and digital clinical workflows during the American Academy of Ophthalmology (AAO) annual meeting, scheduled for October 10-12 in New Orleans.

The company said its AAO presence will include milestones for Veracity Surgery Planner, Smile and Smile pro, and DORC TissueBlue, as well as updates involving surgical visualization, corneal topography, patient engagement, clinical data management, and visual field testing.

“From diagnosis to surgery and ongoing care, Zeiss is advancing the future of ophthalmology by redefining what is possible through optical and digital innovation,” Andreas Völker, head of the Ophthalmology Strategic Business Unit at Zeiss Medical Technology, said in a statement.

Veracity Surgery Planner surpasses 3 million planned cases

Zeiss announced that Veracity Surgery Planner has surpassed 3 million surgical cases planned.

The cloud-based cataract surgery planning software is designed to automate routine tasks and connect devices and clinical data, allowing surgical teams to access information and develop surgical plans across the cataract workflow.

The company plans to recognize the milestone at its AAO booth and host a session with I. Paul Singh, MD, of Eye Centers of Racine & Kenosha, discussing the technology.

Federico Villegas, head of Zeiss Medical Technology U.S. and president of Carl Zeiss Meditec. said the milestone, together with the company's refractive surgery growth, reflects Zeiss' position in ophthalmology and its focus on improving clinical outcomes and expanding access to eye care.

Head-mounted display expands Artevo 850 visualization options

Zeiss will also showcase the HMDmd CR3, an optional lightweight head-mounted display for use with the Artevo 850 surgical microscope.

The wearable display provides access to digital visualization features available through the microscope, including DCA, Smart DoF, adjustable RGB LED light temperature, and AdVision overlays. These can incorporate OCT scans, cataract refractive assistance functions, and information from connected devices.

According to the company, the display is designed to support a neutral head position and improve visual comfort during procedures.

Jason Jones, MD, ophthalmologist and founder of Jones Eye Clinic, is scheduled to discuss his experience using the Artevo 850 with the head-mounted display during an AAO booth session.

TissueBlue reaches US procedure milestone

Zeiss also reported that DORC TissueBlue has now been used in more than 1 million procedures in the United States.

The product is used for staining the internal limiting membrane during ophthalmic surgery. Zeiss plans to highlight the milestone at its AAO exhibit.

Atlas 500 gains ocular surface evaluation enhancements

The company will showcase an updated version of the Atlas 500 corneal topographer, with enhancements intended to support ocular surface disease evaluation and anterior segment assessment.

Updates include a patient screen that directly displays the topography map, expanded tooltips, notation improvements, and additional topographic information with ring and zone values at 0, 1, 2, 3, and 4 mm.

The system uses Placido-disk technology and connects with Zeiss Forum for patient scheduling and data storage.

Smile platforms reach 15 million treated eyes

Zeiss reported that more than 15 million eyes worldwide have now been treated with Smile and Smile pro, up from the 10 million-eye milestone announced in 2024.

The systems are used for keratorefractive lenticule extraction (KLEx). Zeiss commercialized Smile in 2011 and said the platforms are now used by more than 3,000 surgeons in more than 80 countries.

VisioGen updates target patient engagement and online visibility

Zeiss will also highlight updates to VisioGen, its artificial intelligence-based patient engagement platform for ophthalmology practices.

According to the company, the system responds to website inquiries to help convert prospective patients into scheduled appointments, with a licensed optometrist reviewing each response.

A new Practice Visibility Accelerator component is intended to identify and address website and online visibility issues to improve practice searchability. Zeiss also said VisioGen now integrates with the 10 leading electronic health record and practice management systems in the United States.

The company plans to present implementation data from 3 US ophthalmology practices at AAO. Across those practices, Zeiss said VisioGen answered 1,397 website inquiries that were traced to 215 completed surgeries.

Matrix-VR previews headset-based visual field testing

In glaucoma diagnostics, Zeiss will preview Matrix-VR, an ultra-light headset perimeter currently under development and powered by Envision Health Technologies.

The virtual reality-based visual field assessment system is being developed to complement Humphrey Field Analyzer testing. According to Zeiss, the headset is intended to help practices screen more patients for glaucoma while integrating screening results into clinical decision-making workflows.

The technology combines Envision Health Technologies' virtual reality and patient engagement software with Zeiss' experience in visual field testing and diagnostic connectivity.

Lama Al-Aswad, MD, MPH, glaucoma surgeon and founder and CEO of Envision Health Technologies, is scheduled to discuss the technology and the future of visual field testing during an AAO session at the Zeiss booth.

Clinic 360 adds cloud-based clinical data management option

Zeiss will also showcase Clinic 360, a recently FDA-cleared cloud- and browser-based software platform designed to aggregate clinical data and support analytics across ophthalmic workflows.

The platform provides an alternative to the company's Forum on-premise data management system. Zeiss said Clinic 360 is designed for practices seeking a cloud-based, scalable subscription model, while Forum remains available for organizations that prefer local infrastructure.

Jonathan Feistmann, MD, of NYC Retina, a development partner for Clinic 360, is scheduled to discuss his experience with the platform and digitally connected eye care during an AAO booth session.

Zeiss will showcase the technologies at booth 3719 during AAO 2026 in New Orleans.

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Experimental Optogenetic Gene Therapy Shows Potential to Restore Vision in GA https://eyewire.news/news/experimental-optogenetic-gene-therapy-shows-potential-to-restore-vision-in-ga Tue, 06 Oct 2026 13:43:40 GMT https://eyewire.news/news/experimental-optogenetic-gene-therapy-shows-potential-to-restore-vision-in-ga For approximately 1 million Americans living with geographic atrophy (GA), currently available treatments can slow disease progression but cannot restore vision that has already been lost. Research presented at the 130th annual meeting of the American Academy of Ophthalmology (AAO) suggests an experimental gene therapy could offer a different approach. Investigators reported that a single injection of sonpiretigene isteparvovec, known as son-vec (Nanoscope Therapeutics), improved vision in patients with Stargardt disease and demonstrated encouraging activity in a nonhuman primate model designed to mimic GA, according to research being presented at AAO news release.  

The findings have supported plans to move the therapy into a randomized phase 2 trial in patients with dry AMD without first conducting a separate phase 1 study in this population, according to the researchers.

“There are currently FDA-approved treatments to slow down geographic atrophy progression, but no treatments are currently available to improve vision,” David S. Boyer, MD, lead investigator of the study, said in a statement. “Having a one-time injection, which appears safe, that may improve vision for my patients was a great reason to do the study.”

Using surviving retinal cells to respond to light

Son-vec uses an optogenetic approach intended to restore visual function after photoreceptors have been lost.

Photoreceptors—the rods and cones of the retina—convert light into electrical signals that ultimately allow the brain to produce visual images. Their progressive loss is a central feature of several retinal degenerative diseases, including GA. Rather than attempting to preserve or replace damaged photoreceptors, son-vec delivers a gene to bipolar cells, retinal neurons that normally transmit signals from photoreceptors and can remain intact after photoreceptor loss.

The therapy causes these cells to express a light-sensitive protein known as an opsin. This is intended to make the surviving bipolar cells directly responsive to light, effectively recruiting another part of the retinal circuitry to compensate for lost photoreceptor function.

Son-vec is administered as a single intravitreal injection.

Phase 2 data show visual gains in Stargardt disease

The findings presented at AAO included results from an open-label, multicenter phase 2 trial involving patients with Stargardt disease. Patients received a single injection of son-vec and entered the study with visual acuity of 20/200 or worse.

Among patients whose atrophy was confined to the macula, investigators reported an average improvement of 12 letters on a standard eye chart, representing a gain of more than 2 lines of vision.

The treatment was reported to be well tolerated, with no serious adverse events observed.

Researchers also presented findings from a dose-ranging study in nonhuman primates with laser-induced retinal damage designed to model GA. The study demonstrated expression of the therapy's protein in retinal neurons. Treated eyes also demonstrated significantly stronger electrical responses on multifocal electroretinography, which measures localized retinal responses to light, according to the investigators.

Son-vec has additionally been evaluated in patients with retinitis pigmentosa, another inherited retinal disorder involving photoreceptor degeneration, with improvements reported in some measures of visual function.

Despite the encouraging findings, the researchers emphasized that the human efficacy data presented to date are from patients with Stargardt disease rather than patients with GA secondary to AMD.

The Stargardt study was also open-label, meaning investigators and participants knew that treatment had been administered. A randomized controlled study in patients with GA will therefore be important for determining whether the findings translate to the larger population of patients with dry AMD.

Randomized geographic atrophy trial planned

Investigators are now preparing to evaluate son-vec in a randomized phase 2 trial involving patients with GA. If the results support continued development, Dr. Boyer said the next goal would be to conduct phase 2b/3a trials to confirm the findings and support a potential application for FDA approval.

For ophthalmologists treating patients with advanced dry AMD, Dr. Boyer characterized the early findings as a reason for cautious optimism.

“There may be a treatment for patients with visual loss secondary to geographic atrophy in the future that hopefully will result in visual gains,” he said.

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Nanoscope Announces Participation at Eyecelerator and AAO https://eyewire.news/news/nanoscope-announces-participation-at-eyecelerator-and-aao Tue, 06 Oct 2026 13:28:13 GMT https://eyewire.news/news/nanoscope-announces-participation-at-eyecelerator-and-aao

Nanoscope Therapeutics announced that its optogenetics gene therapy (Mogenry, MCO-010) will be featured in various scientific programming at the American Academy of Ophthalmology (AAO) 2026 annual meeting taking place October 8–13, 2026, in New Orleans. Additionally, the company will participate in Eyecelerator@AAO 2026 with a company presentation and panel participation. 

Presentation Details:

Eyecelerator 2026, Ernest N. Morial Convention Center

Panel: Emerging Innovations in Retinal Therapies

Panelist: Sam Barone, MD, Chief Medical Officer

Date & Time: Thursday, October 8, 2026, 10:45–11:30 AM CT

Location: La Nouvelle Ballroom C

Company Presentation: Retina Drug Delivery & New Targets Showcase

Presenter: Paul Hallen, Chief Operating Officer

Date & Time: Thursday, October 8, 2026, 1:00–1:05 PM CT

Location: Rooms 252–254

AAO 2026 Annual Meeting, Ernest N. Morial Convention Center

Presentation: Lasting Vision Improvement in Retinitis Pigmentosa: REMAIN 4-Year Study Data From the RESTORE Phase 2b/3 Trial of MCO-010 Optogenetic Therapy

Session: PA044

Presenter: Kenneth C. Fan, MD

Date & Time: Sunday, October 11, 2026, 11:42–11:49 AM CT

Location: Rooms 255–257

Scientific Poster: Vision Improvement in Dry AMD With Sonpiretigene Isteparvovec Optogenetic Therapy: First Direct-to-Phase 2 RCT

Session: PO624

Presenter: David S. Boyer, MD

Availability: On demand

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Cure Blindness Project Plans More than 770,000 Eye Screenings for World Sight Day https://eyewire.news/news/cure-blindness-project-plans-more-than-770000-eye-screenings-for-world-sight-day Tue, 06 Oct 2026 13:22:36 GMT https://eyewire.news/news/cure-blindness-project-plans-more-than-770000-eye-screenings-for-world-sight-day Key Takeaways

  • Cure Blindness Project plans to facilitate more than 770,000 eye screenings across Asia, Africa, and the Caribbean for World Sight Day 2026
  • Programs include screenings and treatment as well as workforce training, public education, infrastructure development, and national eye health initiatives
  • The activities contribute to IAPB's broader goal of conducting 2 million eye screenings through more than 250 partners worldwide

Cure Blindness Project announced plans to facilitate more than 770,000 eye screenings across Asia, Africa, and the Caribbean in recognition of World Sight Day on October 8, 2026.

The initiative is part of the International Agency for the Prevention of Blindness's (IAPB) global effort to conduct 2 million eye screenings through more than 250 partners. Cure Blindness Project said its activities will focus on identifying vision problems, connecting patients with treatment, and strengthening sustainable eye care systems in underserved communities.

“World Sight Day gives us an opportunity to focus global attention on the millions of people who still lack access to basic eye care,” K-T Overbey, CEO of Cure Blindness Project, said in a statement. “These 770,000 screenings represent far more than a number—they are opportunities to identify vision problems, connect people with treatment and help ensure quality eye care is available in communities for generations to come.”

Country teams and partner organizations will mark World Sight Day with screening, treatment, education, training, and other initiatives designed to expand access to eye care.

Eye health initiatives planned across South Asia

In Bhutan, the Ministry of Health, with support from Cure Blindness Project and the World Health Organization, plans to officially disseminate the country's National Eye Health Strategy for the next 5 years on World Sight Day. The strategy is intended to provide a framework for coordinated, long-term eye care planning.

In India, students will participate in a “Love Your Eyes” school poster contest. A community screening and awareness campaign in Sikkim will also offer eye screenings, referrals, and eye health education.

In Nepal, the Tilganga Institute of Ophthalmology and Cure Blindness Project will conduct a national eye health awareness campaign incorporating screenings, public education, media outreach, and community engagement aimed at encouraging timely access to care.

Programs target access and workforce development in Africa

In Ethiopia, Cure Blindness Project's School Eye Health Project will screen tens of thousands of students across 20 primary schools. Children will receive assessments, treatment, and referrals, with free eyeglasses provided when needed. Teachers and school health personnel will also receive training intended to help integrate eye health into routine school activities.

In Ghana, Cure Blindness Project and its partners have performed more than 12,000 sight-restoring surgeries in hard-to-reach areas during 2026, according to the organization. They have also trained 40 ophthalmic nurses to identify and manage eye conditions and strengthen referral pathways.

The organization is also supporting Ghana's Ministry of Health as it begins developing a National Human Tissue and Organ Transplantation Policy.

In South Sudan, surgical outreach programs have restored sight to nearly 5,000 patients during the past 6 months, according to Cure Blindness Project. The country is also preparing to launch an Ophthalmic Clinical Officers training program intended to decentralize eye care and increase access.

In Eritrea, the organization is supporting specialized eye care capacity through biomedical training for engineers responsible for maintaining surgical equipment and advanced training for ophthalmology residents.

Caribbean initiative targets expanded access

In Antigua and Barbuda, Cure Blindness Project is serving as a lead partner in the Prime Ministerial Vision Initiative.

Plans include 20,000 eye screenings, the establishment and equipping of 2 eye care centers, and a surgical outreach scheduled for late October. The broader initiative is intended to help establish what organizers describe as the first Blindness-Free Zone in the Caribbean.

Building sustainable eye care systems

The World Sight Day programs build on Cure Blindness Project's broader efforts to increase access to eye care while developing local clinical capacity and infrastructure.

Cure Blindness Project and its partners report having collectively performed more than 2 million sight-restoring surgeries, trained more than 20,000 eye care professionals, and provided screenings and basic treatment to more than 20 million people across 30 countries.

The organization said its model combines immediate screening and treatment with investments in local professionals, facilities, and health systems to support sustainable access to eye care.

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Stoke Therapeutics to Present STK-002 Data for Autosomal Dominant Optic Atrophy at AAO https://eyewire.news/news/stoke-therapeutics-to-present-stk-002-data-for-autosomal-dominant-optic-atrophy-at-aao Tue, 06 Oct 2026 13:16:03 GMT https://eyewire.news/news/stoke-therapeutics-to-present-stk-002-data-for-autosomal-dominant-optic-atrophy-at-aao Key Takeaways

  • Stoke Therapeutics will present data on investigational RNA medicine STK-002 in 2 presentations at AAO 2026
  • The Phase 1 OSPREY study is progressing through dose escalation, with cohorts 3 and 4 expected to reach therapeutic dosing levels
  • Initial safety and efficacy data from the higher-dose cohorts are anticipated in the first half of 2027

Stoke Therapeutics announced that data for its investigational RNA medicine STK-002 will be featured in 2 presentations at the 2026 American Academy of Ophthalmology (AAO) annual meeting, taking place October 9-12 in New Orleans.

STK-002 is being developed for the treatment of autosomal dominant optic atrophy (ADOA), the most common inherited optic nerve disorder. The investigational therapy is designed to address the underlying cause of the disease by increasing OPA1 protein levels, with the goal of improving vision.

There are currently no approved treatments for ADOA, according to Stoke.

“ADOA causes progressive and irreversible vision loss in both eyes with 80% of patients symptomatic by age 10 and approximately half progressing to legal blindness,” Barry Ticho, MD, PhD, chief medical officer of Stoke Therapeutics, said in a statement. “We are encouraged by our preclinical data as well as emerging findings from the field demonstrating that upregulation of OPA1 protein may have disease-modifying potential."

STK-002 is currently being evaluated in the phase 1 OSPREY study in patients with ADOA. Dose escalation is ongoing, with the first 2 dose cohorts completed and the third cohort expected to be completed by the end of 2026. According to Stoke, cohorts 3 and 4 are expected to reach therapeutic dosing levels. Initial safety and efficacy findings from these higher-dose cohorts are anticipated during the first half of 2027.

The data being presented at AAO 2026 provide translational evidence supporting the potential of increasing functional OPA1 protein as a disease-modifying approach in ADOA, according to the company.

Details of the presentations are as follows:

Title: OSPREY: First-in-Human Phase 1 Study of the RNA-Based Therapy STK-002 in Autosomal Dominant Optic Atrophy
Podium Poster Date & Time: Sunday, October 11, 10:30-10:40 AM CT
Presenting Author: Patrick Yu-Wai-Man, M.D., Ph.D., Professor of Ophthalmology at the University of Cambridge and the UCL Institute of Ophthalmology, and Honorary Consultant Neuro-ophthalmologist at Addenbrooke’s Hospital and Moorfields Eye Hospital, United Kingdom
Poster Number: PO055

Title: RNA-Based OPA1 Upregulation in Autosomal Dominant Optic Atrophy: First-in-Human STK-002 Study in Mitochondrial Optic Neuropathy
Poster Panel Discussion Date & Time: Sunday, October 11, 3:15–3:21 PM CT
Presenting Author: Nancy J. Newman, M.D., Professor, Departments of Ophthalmology, Neurology and Neurological Surgery, Emory University School of Medicine
Poster Number: PO222

 

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Harrow Closes Acquisition of Tyrvaya from Viatris https://eyewire.news/news/harrow-closes-acquisition-of-tyrvaya-from-viatris Tue, 06 Oct 2026 12:53:48 GMT https://eyewire.news/news/harrow-closes-acquisition-of-tyrvaya-from-viatris Key Takeaways

  • Harrow completed its acquisition of worldwide rights to Tyrvaya, excluding Japan, for $30 million upfront and up to $70 million in sales-based milestone payments
  • The FDA-approved nasal spray expands Harrow's dry eye portfolio alongside Vevye and provides a treatment option with a different route of administration.

Harrow announced the closing of its previously disclosed acquisition of Tyrvaya (varenicline solution) nasal spray 0.03 mg from Viatris, adding a second branded dry eye disease (DED) therapy to its ocular surface portfolio.

Under the transaction, Harrow acquired worldwide rights to Tyrvaya, excluding Japan. Viatris retained commercialization rights in Japan and will pay Harrow royalties on future net sales in that market. Harrow paid $30 million in cash at closing, funded with cash on hand. The agreement also includes up to $70 million in contingent milestone payments tied to Tyrvaya net sales, bringing the potential total consideration to $100 million.

Tyrvaya is a cholinergic agonist indicated for the treatment of the signs and symptoms of DED. It is the first and only FDA-approved nasal spray for the condition. Rather than being applied to the ocular surface, Tyrvaya is administered intranasally and is thought to activate the trigeminal parasympathetic pathway to stimulate basal tear production.

The therapy is approved in the United States, China, and Taiwan, with marketing applications pending in additional markets, according to Harrow.

The acquisition expands Harrow's presence in the dry eye market and complements Vevye, its existing prescription therapy for DED. Harrow said the products' different mechanisms and routes of administration could provide eye care professionals with greater flexibility when individualizing treatment.

Tyrvaya will be available to eye care professionals through Harrow's commercial organization immediately following the transaction's closing.

As part of the acquisition, Harrow expects approximately 40 Viatris personnel with knowledge of Tyrvaya and the dry eye market to join its ocular surface commercial organization. The company expects to onboard those employees during the fourth quarter of 2026.

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