EyePoint DURAVYU 第二个关键III期 LUCIA 未达湿性AMD主要终点，盘前暴跌约84%

EyePoint, Inc. (EYPT), a clinical-stage biopharmaceutical company developing treatments for serious retinal diseases, announced topline results from LUCIA, the second pivotal Phase 3 trial evaluating DURAVYU (vorolanib intravitreal insert) for wet age-related macular degeneration (AMD).
The trial did not meet its primary endpoint of statistical non-inferiority in mean change in best-corrected visual acuity (BCVA) compared with on-label aflibercept 2 mg, despite demonstrating visual improvement.
LUCIA enrolled 475 patients and compared DURAVYU 2.7 mg administered every 24 weeks with aflibercept 2 mg administered every eight weeks, with supplemental aflibercept injections permitted as needed.
Key secondary endpoints were met, including a 38% reduction in treatment burden compared with the control regimen (nominal p-value less than 0.0001). At Week 56, 52% of eyes treated with DURAVYU remained free of supplemental injections, while 71% required zero or one supplemental injection. The treatment also demonstrated strong anatomical control.
DURAVYU maintained a favorable safety profile with redosing. EyePoint reported no dose-related safety concerns in the LUCIA results and said the findings were consistent with those from the earlier LUGANO Phase 3 trial.
However, LUGANO also failed to meet its primary endpoint in the full dataset, despite showing visual improvement and a 42% reduction in treatment burden. EyePoint said it will conduct additional analyses of the LUCIA and pooled Phase 3 data to assess the next steps for DURAVYU in wet AMD.
DURAVYU is an investigational sustained-delivery therapy combining vorolanib, a tyrosine kinase inhibitor, with EyePoint's proprietary Durasert E technology. It is designed to inhibit VEGF signaling and the IL-6/JAK1 inflammatory pathway while potentially reducing the frequency of retinal injections.
Meanwhile, EyePoint continues to advance DURAVYU in diabetic macular edema (DME). The Phase 2 VERONA trial met its primary endpoint, demonstrating a longer time to first supplemental injection compared with aflibercept control. At Week 24, the 2.7 mg dose showed a seven-letter gain in visual acuity and a 76-micron reduction in central subfield thickness, with 73% of patients remaining supplement-free compared with 50% in the control group.
The company said its pivotal Phase 3 DME trials, COMO and CAPRI, remain on track, with topline results expected in the fourth quarter of 2027.
DURAVYU remains investigational and has not been approved by the U.S. Food and Drug Administration. Its safety and efficacy have not been established for commercial use.
EYPT has traded between $2.93 and $19.11 over the last year. The stock closed Friday's trade at $2.99. In the premarket trading, the stock is trading at $0.46, down 84.43%.
For comments and feedback contact: editorial@rttnews.com
Business News
October 16, 2026 16:06 ET Monthly consumer price inflation data and retail sales figures were the main news from the U.S. economy this week. In Europe, monthly GDP figures from the U.K. gained attention. External trade data from China was in focus in Asia. Elsewhere, the International Monetary Fund released its latest projections for the global economy.