UPDATE 1-EyePoint's late-stage eye drug trials to continue after safety panel review
EyePoint, Inc. EYPT | 0.00 | |
Regeneron Pharmaceuticals, Inc. REGN | 0.00 | |
Ocular Therapeutix Inc OCUL | 0.00 |
Adds analyst comment in bullet 6
May 14 (Reuters) - EyePoint EYPT.O 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 REGN.O 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 OCUL.O, accusing it of making misleading statements about EyePoint and Duravyu.
