DURAVYU Fails Second Straight Phase 3 Wet AMD Trial as LUCIA Misses Primary Endpoint
EYPT is trading near its 52-week low of $2.93 (2.0% above the low).
Summary
LUCIA, the second pivotal Phase 3 wet AMD trial of DURAVYU, missed its primary endpoint of statistical non-inferiority in BCVA change versus on-label aflibercept, despite showing visual improvement. This is the second consecutive Phase 3 wet AMD failure, following LUGANO's miss disclosed August 17th, and effectively closes the wet AMD path for the lead asset; EyePoint, Inc. (EYPT) is ending its wet AMD trials and cutting roughly 53% of staff after the miss, and has announced a strategic prioritization. Secondary endpoints held up — a 38% reduction in treatment burden, 52% of eyes supplement-free and 71% receiving zero or one supplement through Week 56, plus a favorable safety profile with redosing — but efficacy on the primary vision measure is what regulators and partners weigh. Management said it will run additional analyses of LUCIA and pooled Phase 3 data to assess next steps in wet AMD, while pointing to the DME program, where Phase 2 VERONA met its primary endpoint. The stock is already trading near its 52-week low of $2.93 after the LUGANO miss, and this removes the remaining near-term wet AMD catalyst. The DME Phase 3 COMO and CAPRI topline readout is now the sole value driver, with data not expected until Q4 2027 — a long funding runway to bridge on a company that posted a $94.5M quarterly loss.
At the time of this announcement, EYPT was trading at $2.99 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $257.8M. The 52-week trading range was $2.93 to $19.11. This news item was assessed with negative market sentiment and an importance score of 9 out of 10. Source: GlobeNewswire.