Ophthalmology Month in Review: May 2025

May was a busy start to the summer, both for regulatory and research news in ophthalmology. The US Food and Drug Administration (FDA) gave a slew of approvals and clearances towards the end of the month: immunoglobulin eye drops received the Investigational New Drug (IND) clearance, and Susvimo and acoltremon ophthalmic solution were approved for diabetic retinopathy and dry eye disease (DED) respectively.

HCPLive also covered the New York State Ophthalmological Society (NYSOS)’s 2025 Envision conference and the Association for Research in Vision and Ophthalmology (ARVO)’s 2025 Annual Meeting. We spoke with presenting clinicians and researchers about the newest findings in the field, from a novel perspective on Coats’ disease to Phase 2 trial results for a one-shot treatment for neovascular age-related macular degeneration (nAMD).

FDA Approvals

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

IG drops, derived from pooled human plasma, have a beneficial effect on each of the inflammatory mechanisms active during DED. IND clearance will allow parent company Selagine, Inc. to begin administering IG drops in clinical trials, putting the company in an excellent position for their upcoming Phase 3 trials. Selagine has stated that they intend to have IG drops accessible in retail pharmacies by early 2029.

FDA Approves Susvimo for Treatment of Diabetic Retinopathy

After positive results from the Phase 3 Pavilion study, Susvimo became the first and only FDA-approved continuous delivery treatment to maintain vision in patients with diabetic retinopathy. A ranibizumab injection administered repeatedly via the Port Delivery System (PDS), Susvimo requires one refill every 9 months, substantially decreasing treatment burden to patients by extending dosage intervals. Parent company Genentech, part of the Roche Group, has already released the medication to US retina specialists.

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

The third and final move by the FDA this month saw acoltremon ophthalmic solution (TRYPTYR) approved for dry eye disease. A first-in-class transient receptor potential melastatin 8 channel receptor agonist, acoltremon ophthalmic solution stimulates the corneal sensory nerves to generate and sustain tear production. Parent company Alcon also announced its intention to launch the newly approved treatment during the third quarter of 2025 in the form of single-dose vials to be administered with one drop per eye twice daily.

HCPLive at ARVO

SAGA Trial Results for Gildeuretinol Treating Geographic Atrophy with David Boyer, MD

Results from SAGA, a 24-month, double-masked, randomized, placebo-controlled study investigating gildeuretinol’s ability to treat geographic atrophy, were presented at the 2025 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting. Although the trial’s primary endpoint of fundus autofluorescence (FAF) change was not achieved, investigators still consider it a success as it exhibited fewer vision losses and better low luminance vision versus sham. Plans for a phase 3 trial have not been announced.

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

ARVO 2025 also saw the presentation of results from the phase 2 LUNA trial of ixoberogene Soroparvovec (Ixo-vec) intravitreal gene therapy for the treatment of neovascular age-related macular degeneration (nAMD). At week 52 of the study, investigators found maintenance of best-corrected visual acuity (BCVA) and central subfield thickness (CST), two of the principal factors of nAMD. The team suggests that LUNA highlights the safety, efficacy, and tolerability of Ixo-vec, which they have posited may go on to act as a 1-shot therapy for nAMD in the future.

Retinal Fluid and Visual Acuity After PDS with Ranibizumab, With Veeral Sheth, MD, MBA

Another important presentation at ARVO 2025 was the volumetric analysis of results from the Archway phase 3 trial evaluating the Port Delivery System (PDS) with ranibizumab in patients with nAMD. Notably, this analysis utilized a deep learning model to identify and segment subretinal and intraretinal fluid (SRF and IRF) on optical coherence tomography scans. The ultimate result of the analysis indicated that BCVA is substantially higher in patients with less IRF fluctuation than with more.

HCPLive at NYSOS Envision

Genetic Insights into Coats Disease, With David H. Abramson, MD

A case study regarding pediatric Coats’ disease, presented at the New York State Ophthalmological Society (NYSOS) Annual Meeting, revealed that the disease can manifest bilaterally, in addition to being caused by a gene long believed to be associated with a separate ophthalmic condition. This largely flies in the face of existing literature, which is emphatic in its statement that Coat’s disease cannot exist, or at least not commonly, in both eyes at once.

A Novel Approach to Treating Glaucoma and Haab’s Striae with Danielle Trief, MD

This surgical video presentation from Envision 2025 displayed a unique, novel method of treating patients with glaucoma who exhibit Haab’s striae on the surface of the cornea. The operating doctor physically peeled the striae off the eye, exposing a smooth corneal surface suitable for graft adhesion. After this procedure, the patient exhibited improved eyesight, from counting fingers to 20/80 during the postoperative period.