Ophthalmology Month in Review: July 2025

Although July was a relatively quiet month for ophthalmology on the US Food and Drug Administration’s front, it did see substantial growth in research across the board. Geographic atrophy, diabetic macular edema, neovascular age-related macular degeneration, and more diseases all saw significant steps forward in treatment and diagnosis. New medications and therapies have advanced significantly through successful clinical trials, and while few are currently at the approval stage, each one shows substantial promise.

This month, HCPLive attended the 43rd Annual Scientific Meeting of the American Society of Retina Specialists in Long Beach, CA. While on-site, we interviewed clinicians, researchers, and specialists about all of the latest research in ophthalmology, from gene therapy to upcoming medications in the pipeline.

FDA News

FDA Accepts Reproxalap Application for Dry Eye Disease

The only critical news from the FDA this month, the approval of reproxalap in DED has resulted in the first and only aceclidine-based eye drop for the treatment of presbyopia in adults. Parent company LENZ Therapeutics plans for samples to become available in October 2025. The medication’s sole active ingredient, aceclidine, is also a new chemical entity in the US, marking a global first in presbyopia treatment.

HCPLive at ASRS 2025

PDS Ranibizumab Retains Visual Acuity Gains in nAMD, with John Kitchens, MD

Data from the ongoing Archway-Portal extension study have shown the safety and efficacy of ranibizumab continuously delivered through the Port Delivery System (PDS) in patients with neovascular age-related macular degeneration and ≥5 prior anti-VEGF injections. The IVAN and CATT trials were used as datasets; patients who had exited the trial had their current visual acuity compared to gains made during the trials, showing loss of acuity gains after exit. Investigators saw a sharp increase in BCVA at week 240 of the trial, indicating successful treatment of nAMD.

Intravitreal UBX1325 Shows Efficacy in Diabetic Retinopathy, DME, with Dante Pieramici, MD

Recent data have indicated the safety and efficacy of UBX1325, an intravitreal injection targeting cellular senescence to slow the progression of diabetic macular edema and diabetic retinopathy. The BEHOLD and ASPIRE trials have shown significant improvements in BCVA, with UBX1325 remaining well-tolerated throughout. Given the unique mechanism of action behind the medication, this treatment may open new doors for a variety of other ocular treatments.

Early Treatment Recommended for Geographic Atrophy, with Roger Goldberg, MD, MBA

A trial of pegcetacoplan has shown the need for early intervention in patients with geographic atrophy. Patients who completed the OAKS and DERBY trials formed the backbone of the GALE open-label extension study, examining the difference in GA lesion growth between patients continuing pegcetacoplan treatment and those crossing over from sham. Investigators found that patients who had received prior treatment exhibited greater lesion reduction, cementing the need for earlier intervention in disease management.

New Ophthalmology Research

EYP-1901 Intravitreal Insert Noninferior to Aflibercept in Treating nAMD

EYP-1901, a new bioerodible, sustained-release intravitreal insert, set to deliver vorolanib in patients with nAMD, has shown its noninferiority to aflibercept treatment in the DAVIO 2 trial. A singular EYP-1901 dose brought about equivalent results in visual acuity compared to aflibercept 2 mg every 8 weeks for 6 months. This opens up the potential for a much longer dose extension than aflibercept, potentially even resulting in a one-and-done therapy.

Interleukin-4 Correlated to Inflammation Regulation in Diabetic Retinopathy

Cytokine intraocular inflammatory mediator interleukin-4 has been implicated in inflammation regulation, tissue repair, T helper 2 cell-mediated immunity, and vascular remodeling, all of which position the treatment to aid in preventing diabetic retinopathy. Data from the INSPIRE study showed higher IL-4 levels in patients with proliferative DR and drew a positive correlation between it and vitreous VEGF concentration, both of which indicate a significant role in the activation of vascular proliferation. Investigators noted that this relation could open doors to new methods of treatment via IL-4.

Faricimab Supports Dose Interval Extension in Treatment-Naïve Patients with nAMD

Post-hoc analyses of the TENAYA and LUCERNE trials showed that patients on extended dosing of faricimab for nAMD exhibited lower baseline central subfield thickness (CST), lower pigment epithelial detachment (PED) thickness, and more fibrovascular PEDs at baseline. Investigators also measured the potential for further dose extension during the treat-and-extend phase, indicating the possibility of a lower maximum PED thickness and the absence of subretinal fluid at week 12.