secwatch.observer — SEC 8-K summary
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Issuer:     Ocugen, Inc. (OCGN)
CIK:        0001372299
Form:       8-K
Filed at:   2026-09-08T21:27:11+00:00
Accession:  0001104659-26-105968
Event type: other_material
Sentiment:  negative
Materiality: 0.75
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Ocugen doses first patient in OCU410 Phase 3; OCU410ST interim shows negative treatment effect
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- First patient dosed in global Phase 3 registrational trial of OCU410 (AAV5-hRORA) for geographic atrophy secondary to dry AMD.
- FDA granted RMAT designation for OCU410 in July 2026; CBER EOP2 aligned on endpoints, dose, adaptive design, single pivotal BLA path.
- OCU410ST DMC interim (26 subjects: 16 treated, 10 control) at 8 months showed negative direction of treatment effect; futility noted.
- DMC recommended obtaining 8-month follow-up of entire population despite baseline lesion size imbalance in interim sample.
- Company will follow DMC recommendation to continue OCU410ST study per existing protocol.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1372299/000110465926105968/0001104659-26-105968-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1372299/000110465926105968/tm2624985d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-105968

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