EyePoint Inc. (EYPT) had a rough Monday. The company released topline results from its pivotal Phase 3 LUGANO trial for DURAVYU, a treatment for wet age-related macular degeneration (AMD), and the market didn't like what it saw. Shares dropped 70.24% to $3.97, hitting a new 52-week low.
The study compared DURAVYU against an on-label 2 mg aflibercept control. The primary endpoint, which measured changes in baseline visual acuity, was thrown off by a small but problematic group: nine patients (about 4% of the cohort) who experienced vision loss unrelated to wet AMD. This asymmetric subgroup muddied the overall results, causing the trial to miss its primary goal.
But here's where it gets interesting. When EyePoint ran an ad hoc analysis excluding those nine patients, DURAVYU showed it was non-inferior to aflibercept. And in the control group, zero patients lost 15 or more letters, which is actually better than the historical rate of 3% to 5% in similar trials. So the drug seems to work, but the data is messy.
The secondary endpoints, though, were a clear win. DURAVYU cut treatment burden by 42% compared to control, which translates to about two fewer injections per patient through Week 56. That's a big deal for patients who currently have to get eye injections regularly. Plus, 76% of DURAVYU patients were supplement-free through Week 32, and 54% stayed supplement-free through Week 56, all while maintaining consistent anatomic control.
Safety also looked solid. The insert was well-tolerated with repeat dosing. Rates of cataract, elevated intraocular pressure, and inflammation were on par with the control group. No insert migration, retinal vasculitis, or severe intraocular inflammation was reported.
So what's next? EyePoint is waiting on topline data from LUCIA, its second Phase 3 wet AMD trial, expected in the fourth quarter of 2026. If all goes well, they're targeting an NDA filing for DURAVYU in the first half of 2027. And for diabetic macular edema (DME), the COMO and CAPRI trials are scheduled to report topline data in the fourth quarter of 2027.
The stock's reaction shows investors are focused on the primary endpoint miss, but the secondary data and safety profile suggest DURAVYU could still have a future. It's a classic case of mixed results, and the market is voting with its feet for now.
