---
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"
generated_at: "2026-09-08T21:28:10.114374+00:00"
event_type: "other_material"
sentiment: "negative"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Ocugen doses first patient in OCU410 Phase 3; OCU410ST interim shows negative treatment effect

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: other_material
- sentiment: negative
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-105968
- JSON: https://secwatch.observer/filing/0001104659-26-105968.json
- Plain text: https://secwatch.observer/filing/0001104659-26-105968.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.