EyePoint LUGANO misses endpoint despite 42% reduction
Full story: https://grafa.com/en/news/united-states/eyepoint-lugano-phase-3-duravyu-primary-endpoint
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EyePoint said DURAVYU did not meet LUGANO’s primary BCVA endpoint in the full dataset, although an ad hoc analysis showed non-inferiority.
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EyePoint shares were down about 70% at $4.43 in early Nasdaq trading following the results.
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DURAVYU reduced treatment burden by 42%, while EyePoint expects the second Phase 3 LUCIA readout in Q4 2026.
EyePoint (NASDAQ:EYPT) said DURAVYU 2.7mg missed LUGANO’s primary BCVA endpoint against 2mg aflibercept in the full Phase 3 dataset.
An ad hoc analysis excluding nine of 211 DURAVYU patients with unrelated vision loss showed non-inferiority to aflibercept at nominal p=0.0096.
DURAVYU reduced treatment burden 42%, while 54% remained supplement-free and 79% required zero or one supplemental injection through Week 56.
EyePoint expects LUCIA results in Q4 2026 before a potential 1H 2027 NDA filing.
Following the announcement, EyePoint's share price was down 70% at $4.43.
EyePoint ended Q2 with $180 million in cash and investments, which the company expects will fund operations into Q4 2027.
The company has also fully enrolled its COMO and CAPRI Phase 3 DME trials, with topline results expected in Q4 2027.
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