secwatch.observer — SEC 8-K summary ====================================== Issuer: EyePoint, Inc. (EYPT) CIK: 0001314102 Form: 8-K Filed at: 2025-10-14T23:59:59+00:00 Accession: 0001193125-25-239008 Event type: other_material Sentiment: positive Materiality: 0.72 Item codes: 2.02, 8.01, 9.01 LLM model: deepseek-v4-flash:cloud@v2 EyePoint initiates Phase 3 DURAVYU DME program; first patient Q1 2026; dual MOA data -------------------------------------------------------------------------------- - First patient dosing in pivotal Phase 3 DME trials (COMO and CAPRI) expected Q1 2026; trials enroll ~240 patients each. - Non-inferiority design vs aflibercept; primary endpoint is BCVA change from baseline at weeks 52 and 56. - New preclinical data shows vorolanib inhibits IL-6 mediated inflammation via JAK receptors, adding to VEGF blockade. - Company had positive end-of-Phase 2 meeting with FDA; DURAVYU also in Phase 3 for wet AMD. - Estimated cash and investments as of Sept 30, 2025 included in investor presentation (not specified). Source: EDGAR index: https://www.sec.gov/Archives/edgar/data/1314102/000119312525239008/0001193125-25-239008-index.htm Primary doc: https://www.sec.gov/Archives/edgar/data/1314102/000119312525239008/d14832d8k.htm HTML page: https://secwatch.observer/filing/0001193125-25-239008 License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer