secwatch.observer — SEC 8-K summary
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Issuer:     EyePoint, Inc. (EYPT)
CIK:        0001314102
Form:       8-K/A
Filed at:   2025-07-29T23:59:59+00:00
Accession:  0000950170-25-099413
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

EyePoint completes enrollment in both Phase 3 wet AMD trials for DURAVYU; topline data mid-2026
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- LUCIA enrolled over 400 patients in 7 months; combined LUGANO and LUCIA total over 800 patients.
- DSMC interim review confirmed safety consistent with prior trials; no protocol changes, continuation recommended.
- Topline 56-week data for LUGANO expected mid-2026; LUCIA topline data to follow shortly after.
- DURAVYU is sustained-release TKI with 6-month redosing; evaluated vs on-label aflibercept in non-inferiority design.
- Phase 3 program aligned with FDA/EMA; NDA filing targeted after one-year efficacy and safety endpoint.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1314102/000095017025099413/0000950170-25-099413-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1314102/000095017025099413/eypt-20250729.htm
  HTML page:      https://secwatch.observer/filing/0000950170-25-099413

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer