EyePoint, Inc. shares opened down 70% after the Company disclosed that DURAVYU (vorolanib intravitreal insert) failed to meet the prespecified primary endpoint -- change in best-corrected visual acuity versus on-label aflibercept -- in the full dataset of the Phase 3 LUGANO trial for wet age-related macular degeneration. The clinical trial failure occurred despite the Company repeatedly describing the program as "derisked" across at multiple earnings calls from Q4 2024 through Q1 2026. On May 6, 2026, President and CEO Jay Duker stated, "We are confident that our clinically-rigorous, derisked and patient-centric approach will continue to reinforce DURAVYU's best-in-class potential." On June 9, he reiterated that they “remain quite confident and quite optimistic in the results, and we think we can make a difference for patients,” while claiming the company was “underappreciated” at the time as a “derisked asset.” The Company performed an ad hoc analysis excluding a 4% asymmetric patient cohort, but this did not remedy the failure of the prespecified analysis for investors or regulators. The investigation concerns whether EyePoint, Inc. adequately disclosed the risks of the LUGANO trial failing its primary endpoint and the details and risk profile of the asymmetric patient cohort ahead of the clinical trial results disclosure in August 2026.