Ophthalmology First Half Recap: 2025

Ophthalmology is a rapidly growing industry, with constant developments on all fronts and new treatments rapidly moving through the pipeline. Between advancing therapies and groundbreaking technology, clinicians have seen a tremendous variety of changes to the way patients are cared for.

The first half of 2025 saw a slew of landmark approvals from the US Food and Drug Administration (FDA), from a first-in-class TRPM-8 channel receptor agonist to a continuous delivery to increase vision in patients with diabetic retinopathy. Several crucial trials also saw major advancements, and clinicians developed a variety of ways to lessen treatment burdens for their patients. In light of these advancements, and to mark the end of the first half of 2025, HCPLive Ophthalmology created a recap of the biggest news from the last 6 months.

This recap focuses on 5 critical regulatory updates from the FDA, our 5 biggest trial announcement articles, and 3 important insights from top experts featured prominently within our coverage.

First Half of 2025: Regulatory Updates in Ophthalmology

FDA Expands Dosing Label for Avacincaptad Pegol for Geographic Atrophy

On February 13, 2025, an expanded label for avacincaptad pegol intravitreal solution for the treatment of geographic atrophy was approved by the FDA. The decision was based on 2-year results from the phase 3 GATHER2 trial, wherein the drug continued to reduce GA lesion growth rates for both every month and every other month dosing versus sham.

FDA Approves Revakinagene Taroretcel (ENCELTO) for MacTel

On March 6, 2025, the FDA approved revakinagene taroretcel-lwey (ENCELTO) for the treatment of macular telangiectasia type 2, making it the first and only approved treatment for the disease. Parent company Neurotech indicated at the time that revakinagene taroretcel will be available for US patients beginning in June 2025.

FDA Approves Prednisolone Acetate Ophthalmic Suspension for Ocular Inflammation

On June 12, 2025, the FDA approved the self-administered eye drop prednisolone acetate ophthalmic suspension, 1% to treat steroid-responsive ocular inflammation. The treatment is intended for use 2-4 times a day, although during the first 24 hours this frequency may be increased if necessary. Parent company Amneal Pharmaceuticals also announced a planned launch for the third quarter of 2025.

FDA Approves Acoltremon Ophthalmic Solution (TRYPTYR) for Dry Eye Disease

On May 29, 2025, acoltremon ophthalmic solution .003%, a first-in-class transient receptor potential melastatin 8 channel receptor agonist, was approved by the FDA to treat signs and symptoms of dry eye disease. Parent company Alcon has announced its intention to launch acoltremon ophthalmic solution in the US during the third quarter of 2025.

FDA Approves Susvimo for Treatment of Diabetic Retinopathy

On May 22, 2025, the FDA approved susvimo for the treatment of diabetic retinopathy, marking the first and only FDA-approved continuous delivery treatment which can maintain vision in people with DR through only one refill every 9 months. The medication is already available in the US for use in patients who have responded to at least 2 anti-VEGF injections.

First Half of 2025: Trial Announcements in Ophthalmology

Pegcetacoplan Reduces Rate of Geographic Atrophy Growth, 1-Year Trial Data Shows

On May 14, 1015, 12-month results from the ongoing GALE extension study indicated that pegcetacoplan successfully reduced mean geographic atrophy growth with increasing efficacy. Investigators also noted a significant reduction in new scotomatous points. As GALE continues, the team anticipates further evidence for the safety and efficacy of pegcetacoplan for GA treatment.

Sozinibercept for Wet AMD Misses Primary Endpoint in Phase 3 COAST Trial

On March 24, 2025, after receiving a Fast Track designation from the FDA, sozinibercept failed to achieve its primary endpoint of mean change in BCVA over 52 weeks in the COAST trial. Opthea accelerated topline data from the Phase 3 ShORe trial, but this was also announced as a failure in May, leading to the program's complete shutdown.

DURAVYU Hits Primary Phase 2 Endpoint, Reduces Treatment Burden in DME

On February 5, 2025, EyePoint Pharmaceuticals announced positive 6-month data from the phase 2 VERONA trial of vorolanib intravitreal inserts, which reported meaningful improvement in vision and anatomy in patients with diabetic macular edema. The company also noted these data in their program’s advancement to phase; they plan to initiate this next stage by the end of 2025.

Veligrotug Shows Durability for Thyroid Eye Disease in Phase 3 Trial Results

Announced on May 20, 2025, by parent company Viridian Therapeutics, Inc., long-term data from the phase 3 THRIVE trial indicated that veligrotug has positive long-term durability in patients with active thyroid eye disease. This announcement came shortly after the FDA granted veligrotug Breakthrough Therapy designation. Viridian expects to submit the BLA for veligrotug during the second half of 2025.

VVN461 Trial Topline Results Announced for Non-Infectious Anterior Uveitis

Announced on April 25, 2025, by VivaVision, positive phase 2 trial results for VVN461 have indicated noninferiority to comparator drug prednisolone acetate. VVN461 is a dual Janus kinase inhibitor and tyrosine kinase 3 inhibitor to treat non-infectious anterior uveitis. VivaVision has announced its intention to request a type C meeting with the FDA about phase 3 trials and an eventual BLA submission.

First Half of 2025: Expert Perspectives in Ophthalmology

Exploring the Evolution of IOL Technology with Sumitra Khandelwal, MD

Sumitra Khandelwal, MD, a professor of ophthalmology at the Cullen Eye Institute at Baylor College of Medicine and medical director for the Lions Eye Bank of Texas, discusses her presentation on rapidly evolving IOL technology and preoperative diagnostics.

Phase 2 LUNA Trial Results for Ixo-vec to Treat Neovascular AMD with Dante Pieramici, MD

Dante Pieramici, MD, codirector of the California Retina Research Foundation and assistant clinical professor of ophthalmology at the Doheny Eye Center in Southern California, discusses the results of the phase 2 LUNA trial of ixoberogene soroparvovec intravitreal gene therapy to treat nAMD.

New Insight: Exploring ENCELTO for MacTel with Rich Small, CEO of Neurotech

Veeral Sheth, MD, MBA, director of clinical research at University Retina and Macula Associates, speaks with Rich Small, chief executive officer of Neurotech, about the FDA’s landmark approval of revakinagene taroretcel-lwey, an encapsulated cell therapy for the treatment of macular telangiectasia type 2.