{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-105968","form_type":"8-K","ticker":"OCGN","cik":"0001372299","company_name":"Ocugen, Inc.","filed_at":"2026-09-08T21:27:11+00:00","discovered_at":"2026-09-08T21:28:03.552925+00:00","generated_at":"2026-09-08T21:28:10.114374+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"negative","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Ocugen doses first patient in OCU410 Phase 3; OCU410ST interim shows negative treatment effect","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-105968","json":"https://secwatch.observer/filing/0001104659-26-105968.json","markdown":"https://secwatch.observer/filing/0001104659-26-105968.md","text":"https://secwatch.observer/filing/0001104659-26-105968.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1372299/000110465926105968/0001104659-26-105968-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1372299/000110465926105968/tm2624985d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-09-08T21:28:10.114374+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}