Overview
- Shares plunged more than 71% to a 52-week low on Monday, Aug. 17, 2026 after EyePoint published topline results from the Phase 3 LUGANO trial.
- LUGANO did not meet its prespecified primary visual-acuity endpoint in the full study population, which is the key regulatory measure for noninferiority.
- EyePoint reported a post-hoc analysis that excluded nine Duravyu patients who had large vision losses the company says were unrelated to wet AMD and found noninferiority versus aflibercept when those cases were removed.
- The trial delivered several positive secondary findings, including about a 42% reduction in treatment burden, high supplement-free rates through 56 weeks, and a favorable safety and anatomic profile.
- The company says a U.S. filing in the first half of 2027 remains possible but is explicitly contingent on LUCIA topline data due late 2026, and the setback raises near-term commercial risks as rivals press toward FDA submissions and patients await less-frequent treatment options.