May 14 (Reuters) – EyePoint said on Thursday an independent safety committee found no new concerns in two late-stage trials of its experimental eye disease drug Duravyu and recommended the studies continue unchanged.
• The drug, Duravyu, is being tested to treat wet age-related macular degeneration, or wet AMD, a leading cause of vision loss in older adults that can cause blurred vision or a blind spot in the center of vision.
• The independent safety committee completed its third scheduled review and recommended the studies continue without protocol changes.
• EyePoint said topline data from the first study remain on track for mid-2026, with results from the second expected shortly after.
• The studies have enrolled more than 900 patients and are evaluating Duravyu against Regeneron’s blockbuster eye drug, Eylea.
• EyePoint said interim safety data showed a continued favorable safety profile, consistent with results seen in more than 190 patients across four earlier trials.
• RBC Capital Markets analysts said the review was in line with expectations and increased confidence that repeat dosing of EyePoint’s eye drug has not raised safety concerns.
• EyePoint said the main goal of the studies is to show Duravyu works about as well as Eylea in maintaining patients’ vision at weeks 52 and 56.
• The drug is also being tested in late-stage studies for diabetic macular edema, with data expected in the second half of 2027.
• EyePoint in March filed a lawsuit against rival Ocular Therapeutix, accusing it of making misleading statements about EyePoint and Duravyu.
(Reporting by Kunal Das in Bengaluru; Editing by Tasim Zahid)
