EyePoint Pharmaceuticals shares fell 70% to $4.28 after vorolanib (Duravyu) missed the primary endpoint in the Phase 3 LUGANO trial for wet AMD. The company reported strong secondary endpoints including a 42% reduction in treatment burden, while LUCIA topline data in Q4 2026 will determine the path to a potential NDA filing.
EyePoint Pharmaceuticals shares fell 70% to $4.28 after its wet AMD candidate vorolanib (Duravyu) missed the primary endpoint in the Phase 3 LUGANO trial.
"While the primary endpoint result for the full dataset was unexpected, the consistently positive results from the pre-specified secondary endpoints and the ad hoc analysis on the primary endpoint present a compelling case for DURAVYU as a new potential therapeutic option for wet AMD," Jay S. Duker, president and CEO of EyePoint, said.
The trial randomized 427 patients to receive either vorolanib (Duravyu) every six months or on-label aflibercept (Eylea) every eight weeks. Duravyu failed to demonstrate non-inferiority in best corrected visual acuity (BCVA) — the sharpest vision achievable with corrective lenses — across the full dataset. An ad hoc analysis excluding nine of 211 Duravyu patients who lost 15 or more letters from causes unrelated to wet AMD showed non-inferiority (nominal p=0.0096). No patients in the aflibercept arm experienced comparable vision loss.
The miss shifts attention to LUCIA, the twin Phase 3 trial with topline data expected in Q4 2026. EyePoint plans a potential FDA New Drug Application submission in the first half of 2027, pending LUCIA results. Rival Ocular Therapeutix rose more than 6% to $10.72 as its competing TKI candidate axpaxli posted positive Phase 3 data earlier this year.
Duravyu achieved a 42% reduction in treatment burden versus aflibercept (nominal p<0.0001), translating to about two fewer injections per patient through Week 56. Some 76% of Duravyu patients were supplement-free through Week 32, and 54% remained supplement-free through Week 56. The company reported a 4-micron difference in central subfield thickness (CST) — a measure of retinal swelling — versus aflibercept at Week 56.
Mizuho analysts called the readout "mixed" in a Monday note, saying the secondary endpoint data were "excellent" while the primary miss remains "a genuine overhang we can't fully dismiss until LUCIA." The analysts noted that 3-5% of aflibercept patients typically lose 15 or more BCVA letters in past Phase 3 trials, implying the LUGANO control arm may have overperformed.
EyePoint attributed the primary miss to nine patients who experienced vision loss from geographic atrophy (six patients), glaucoma (two), and retinal detachment (one) — conditions unrelated to wet AMD. All nine had good anatomic control of their wet AMD, the company said.
The company plans to present additional LUGANO data at the Retina Society 59th Annual Scientific Meeting in Los Angeles from September 23-26.
The 70% decline puts EyePoint shares at their lowest in 16 months. LUCIA topline data in Q4 2026 will determine whether the company can proceed with its planned NDA filing.
This article is for informational purposes only and does not constitute investment advice.
