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11/20/2025

Coave Therapeutics has announced its lead gene therapy program, CoTx-10, for the treatment of retinal vascular diseases, such as wet age-related macular degeneration (wAMD) and diabetic macular edema (DME).

The company describes CoTx-101 as the combination of a “best-in-class in-office delivery procedure with a first-in-class vector” (coAAV-SCS) to achieve deep retinal pe*******on, broad tissue coverage, and sustained expression of 2 biologics targeting the angiogenesis pathway.

CoTx-101 is intended for the treatment of retinal vascular diseases, such as wet age-related macular degeneration (wAMD) and diabetic macular edema (DME).

11/19/2025

Harrow has completed the acquisition of Melt Pharmaceuticals, which includes product candidates MELT-210, MELT-300, and MELT-400 based on the Zydis ODT (oral dissolving tablet) drug delivery platform.

Melt will now be fully integrated into Harrow’s operations to ensure a “seamless transition and accelerate progress toward NDA submission, approval, and market launch” of MELT-300.

The acquisition includes product candidates MELT-210, MELT-300, and MELT-400 based on the Zydis ODT (oral dissolving tablet) drug delivery platform.

11/19/2025

The Foundation Fighting Blindness has allowed public open access to de-identified 4-year data from individuals participating in RUSH2A, an ongoing natural history study for patients with mutations in the USH2A gene causing Usher syndrome type 2A or non-syndromic retinitis pigmentosa (RP).

According to the foundation, the goal of RUSH2A and other natural history studies sponsored by the organization is to enable researchers and therapy developers to identify new, sensitive, and reliable clinical trial endpoints and inform clinical trial designs for emerging inherited retinal disease (IRD) therapies.

RUSH2A is an ongoing natural history study for patients with mutations in the USH2A gene causing Usher syndrome type 2A or nonsyndromic retinitis pigmentosa (RP).

11/18/2025

Opus Genetics has dosed the first patient in its OPGx-BEST1 phase 1/2 clinical trial, BIRD-1, for Best disease (BEST1).

Best disease, also known as vitelliform macular dystrophy, is a rare, inherited retinal condition causing macular degeneration by mutations in the BEST1 gene, leading to progressive vision loss and potentially blindness. The BEST1 gene is responsible for providing instructions to produce bestrophin, a protein that acts as a channel to manage the movement of charged chloride ions in and out of retinal cells.

Best disease, also known as vitelliform macular dystrophy, is a rare, inherited retinal condition causing macular degeneration by mutations in the BEST1 gene, leading to progressive vision loss and potentially blindness.

11/17/2025

AnnMarie Hipsley, PDT, PhD, founder of ACE Vision Group spoke to the group's advances in ocular biomechanics and vision science. The central theme was moving beyond a lens-centric approach to vision, historically the foundation of presbyopia research, towards a systems-level understanding that encompasses the dynamic interplay between the eye’s biomechanical components.

Hipsley shares insights into ocular biomechanics and dynamic range of focus, that can help the field to work toward vision restoration and increase eye health.

11/17/2025

The timeline for the proposed Alcon acquisition of STAAR Surgical has once again been extended as STAAR announced amendments to the Alcon merger agreement. Prior to the amendment, STAAR delayed its Special Meeting of Stockholders twice—which has now been further delayed a third time to December 19, 2025.

According to STAAR, the amendment allows for “proactive solicitation by STAAR of third-party proposals to maximize value for all STAAR stockholders."

STAAR Surgical extends its merger timeline with Alcon, inviting third-party proposals to maximize stockholder value amid ongoing opposition from Broadwood Partners.

11/16/2025

Apellis Pharmaceuticals recently announced post hoc analysis data of the GALE extension study. This new data is the result of five years of patients continuously treated with SYFOVRE (pegcetacoplan injection) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

The company reported that pegcetacoplan injection—both monthly and every other month—delayed GA lesion growth by around 1.5 years when compared to sham

New five-year data reveals SYFOVRE significantly delays geographic atrophy progression, enhancing understanding of age-related macular degeneration treatment.

11/15/2025

The US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) from Outlook Therapeutics for ONS-5010 (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD).

Earlier this year, the FDA issued a complete response letter (CRL) to Outlook for its BLA for ONS-5010. The CRL included only 1 deficiency, which was due to a lack of substantial evidence of effectiveness. At the time, the FDA advised in the CRL that because ONS-5010 did not meet the primary efficacy endpoint in NORSE EIGHT, confirmatory evidence of efficacy should be submitted to support the application for ONS-5010.

This resubmission follows the complete response letter (CRL) Outlook received in August 2025.

11/14/2025

Sight Sciences has released results from 3 published manuscripts analyzing prospective study data and retrospective registry data that the company claims “further demonstrate the value of an interventional mindset in treating glaucoma.”

Ophthalmology Times connects eye care professionals with surgery, imaging, gene therapy, & diagnostic advances to enhance clinical and patient care.

11/14/2025

A new post-hoc analysis of the Age-Related Eye Disease Study 2 showed that the natural history data and multivariable models may be helpful in clinical practice and trials. While the risk factors for the first development of GA lesions, the subsequent incidence rate of the lesions, and area-based progression overlapped only partially, the investigators reported that their mechanisms may be partially distinct, which has an impact on potential therapeutic approaches.

In the study, authors investigated the natural history of GA lesion incidence rates and analyzed potential risk factors for faster incidence of GA lesions.

11/13/2025

Balancing the demands of medical training with parenthood remains a challenge for many residents, particularly in surgical specialties like ophthalmology. Rishika Garg, a second-year medical student at the University of Oklahoma (OU) College of Medicine in Oklahoma City, recently presented findings from a nationwide analysis examining how maternity and parental leave policies vary across ophthalmology residency programs.

Second-year medical student Rishika Garg shares insights from a nationwide analysis revealing inconsistencies in ophthalmology residency leave policies.

11/13/2025

Optical coherence tomography (OCT) has become so integral to retinal practice that it is nearly impossible to imagine the field without it. Once a novel imaging tool, OCT now serves as a diagnostic cornerstone and a daily guide for treatment decisions. Leading retina specialists recently reflected on how OCT reshaped patient care, efficiency, and the evolution of therapeutic strategies in ophthalmology.

Ophthalmology Times connects eye care professionals with surgery, imaging, gene therapy, & diagnostic advances to enhance clinical and patient care.

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