EyePoint, Inc. Investigation - EYPT

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EyePoint, Inc. (NASDAQ: EYPT)

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EyePoint, Inc. Investigation Details

EyePoint, Inc. shares fell roughly 73% to more than 80% after the Company reported that its Phase 3 LUCIA trial of DURAVYU in wet age-related macular degeneration failed its primary endpoint of non-inferiority to on-label aflibercept. In the trial, DURAVYU delivered approximately +2.5 letters mean BCVA change versus approximately +6.1 letters for the aflibercept control group. Concurrently, EyePoint announced the early conclusion of its wet AMD pivotal trials and a workforce reduction of approximately 53%, expected to generate approximately $30 million in annualized savings alongside approximately $9 million in one-time charges. In an October 15, 2025 Free Writing Prospectus, the Company previously represented that existing funds and offering proceeds would support operations into the fourth quarter of 2027, beyond Phase 3 wet AMD topline data for DURAVYU in 2026. Furthermore, during a March 4, 2026 earnings call, President and Chief Executive Officer Jay Duker stated, "we believe our wet AMD program is uniquely derisked and optimized to support success." In a September 10, 2026 SEC filing, EyePoint presented LUGANO topline results asserting non-inferiority by excluding nine patients who lost visual acuity from non-wet AMD etiologies. The investigation concerns whether EyePoint, Inc. adequately disclosed clinical trial risks and developmental timelines for DURAVYU ahead of the Phase 3 LUCIA primary endpoint failure.

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