EyePoint's Duravyu Eye Drug Clears Safety Review, Late-Stage Trials to Continue
Key Insights
An independent safety committee found no new concerns in EyePoint (search)'s two late-stage trials of Duravyu for wet age-related macular degeneration (search) and recommended the studies continue unchanged.
The trials have enrolled more than 900 patients and are evaluating Duravyu against Regeneron's blockbuster eye drug Eylea, with topline data expected in mid-2026.
Interim safety data showed a continued favorable safety profile, consistent with results from more than 190 patients across four earlier trials.
EyePoint (search) announced Thursday that an independent safety committee completed its third scheduled review of two late-stage trials for its experimental eye disease drug Duravyu and found no new safety concerns, recommending the studies continue without protocol changes.
Trial Progress and Timeline
The ongoing trials are evaluating Duravyu as a treatment for wet age-related macular degeneration (search) (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 studies have enrolled more than 900 patients and are comparing Duravyu's efficacy against Regeneron's established eye drug Eylea.
EyePoint (search) confirmed that topline data from the first study remain on track for mid-2026, with results from the second study expected shortly after. The main goal of the studies is to demonstrate that Duravyu works about as well as Eylea in maintaining patients' vision at weeks 52 and 56.
Safety Profile Remains Favorable
The interim safety data showed a continued favorable safety profile, consistent with results observed in more than 190 patients across four earlier trials. RBC Capital Markets analysts noted that the review was in line with expectations and increased confidence that repeat dosing of EyePoint (search)'s eye drug has not raised safety concerns.
Expanded Development Program
Beyond wet AMD, Duravyu is also being tested in late-stage studies for diabetic macular edema (search), with data expected in the second half of 2027. This expanded development program positions the drug as a potential treatment for multiple retinal conditions.
Legal Developments
In March, EyePoint (search) filed a lawsuit against rival Ocular Therapeutix, accusing the company of making misleading statements about EyePoint and Duravyu, highlighting the competitive landscape in the ophthalmology space.