Q2 2025 Recap: Ophthalmology News and Updates

Ophthalmology has been on a tremendous rise in recent years, with developments on almost every front and new treatments for a slew of diseases. Upcoming therapies and groundbreaking technology have paved the way for attempts to lighten the treatment burden on patients by extending dosing intervals; a number of medications have exhibited efficacy outside of their expected field in ophthalmology; and trial successes have come hard and fast.

Q2 2025 followed many of these patterns, with the US Food and Drug Administration (FDA) handing out approvals to several critically important medications and companies worldwide announcing successful advancements on first-of-their-kind drugs. Niches were filled, treatment burdens were lessened, and alternative therapies were discovered. To mark the end of Q2 2025, HCPLive Ophthalmology created a recap of the biggest news from April to June 2025.

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

Q2 2025 Regulatory Updates in Ophthalmology

FDA Issues Complete Response Letter to Aflibercept 8 mg for Extended Dosing

Announced on April 18, this CRL was specifically for parent company Regeneron’s proposed dosage extension up to 24-weeks. No safety or efficacy issues of aflibercept 8 mg in any of its approved dosing regimens or indications were found; the FDA disagreed instead with an attempt to extend dosing intervals longer than the current maximum of 16 weeks according to the label.

FDA Approves Prednisolone Acetate Ophthalmic Suspension for Ocular Inflammation

On June 12, 2025, the FDA approved the sterile, topical anti-inflammatory agent for the treatment of steroid-responsive ocular inflammation. The medication is a self-administered eye drop intended for use 2-4 times daily. In addition to this approval, parent company Amneal Pharmaceuticals announced a planned launch for the third quarter of 2025.

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

On May 28, 2025, the FDA approved acoltremon, a first-in-class transient receptor potential melastatin 8 channel receptor agonist which stimulates corneal sensory nerves, to treat dry eye disease. Both pivotal phase 3 trials, COMET-2 and COMET-3, displayed rapid onset and sustained tear production, as well as a substantial percentage of patients with a ≥10mm increase in unanesthetized Schirmer’s score across both trials compared to vehicle.

FDA Approves Susvimo for Treatment of Diabetic Retinopathy

Announced on May 22, 2025, this approval marked the third approved indication for Susvimo, along with diabetic macular edema. The medication was made available to US retina specialists from the day that parent company Genentech announced the FDA approval. Susvimo is now the first and only FDA-approved continuous delivery treatment able to maintain vision in people with diabetic retinopathy with only 1 refill every 9 months.

FDA Grants IND Clearance to Immunoglobulin Eye Drops for Dry Eye Disease

On May 21, 2025, the FDA granted Investigational New Drug clearance to Selagine, Inc.’s immunoglobulin drops, an anti-inflammatory and immunomodulatory biologic drug for the treatment of dry eye disease. Selagine and partner Grifols, one of the leading producers of plasma-derived medicines, expect that the IG drops will reach retail pharmacies in early 2029.

Q2 2025 Trial Announcements in Ophthalmology

VVN461 Trial Topline Results Announced for Non-Infectious Anterior Uveitis

Announced April 24, 2025, VivaVision announced that both VVN461-1.0% and VVN461-0.5% showed non-inferior efficacy against a prednisolone acetate comparator cohort in treating NIAU. Although VivaVision is based in China, the company has announced its intention to request a type C meeting with the FDA regarding phase 3 trials and an eventual BLA.

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

On April 23, 2025, 12-month results from the ongoing GALE open-label extension study indicated pegcetacoplan’s ability to reduce the mean rate of geographic atrophy growth. Initiated in response to positive results from the 2-year OAKS and DERBY trials of pegcetacoplan in patients with GA secondary to AMD, GALE is expected to significantly advance the evidence for the medication’s long-term safety and efficacy by its culmination.

Oral Zervimesine Reduces Geographic Atrophy Lesion Growth in Phase 2 Trial

Announced by Cognition Therapeutics on May 8, 2025, the phase 2 MAGNIFY trial resulted in oral zervimesine reducing lesion growth in patients with geographic atrophy secondary to age-related macular degeneration. Simultaneously being developed for Alzheimer’s and dementia with Lewy bodies, the once-daily oral pill may overcome the limitations of current treatment options, which require regular intravitreal injections.

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

Long-term data announced on May 20, 2025, by Viridian Therapeutics, Inc. indicated the positive long-term durability of veligrotug in treating thyroid eye disease. Veligrotug, already granted the Breakthrough Therapy designation by the FDA prior, is also on track with its BLA planned for the second half of 2025.

Opthea Announces Termination of ShORe and COAST Trials of Sozinibercept

On April 2, 2025, Opthea announced the termination of their ShORe and COAST trials after sozinibercept failed to achieve vision improvement benchmarks in treating wet AMD. COAST failed on March 24, which led Opthea to accelerate topline data of the ShORe trial. However, when this trial also missed its benchmarks, Opthea shuttered the trials.

Q2 Expert Perspectives in Ophthalmology

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

Dante Pieramici, MD, 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 for the treatment of neovascular age-related macular degeneration.

Changing Dosage Regimens in Patients with Diabetic Macular Edema, with Mark Barakat, MD

Mark Barakat, MD, founder and director of research at the Retina Macula Institute of Arizona, discusses his post-hoc analysis examining the shortening or extending of aflibercept 8 mg dosage for patients with DME through week 96 of the PHOTON trial.

Switching to Aflibercept 8 mg in Treatment-Experienced Patients with Ted Leng, MD

Theodore Leng, MD, Director of Clinical and Translational Research and Director of Ophthalmic Diagnostics at the Stanford University School of Medicine, discusses the process of switching to aflibercept 8mg from other anti-VEGF agents in patients with neovascular age-related macular degeneration.