---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-24-085603"
form_type: "8-K"
ticker: "OCGN"
cik: "0001372299"
company_name: "Ocugen, Inc."
filed_at: "2024-08-05T23:59:59+00:00"
generated_at: "2026-05-31T13:01:48.600462+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Ocugen gets FDA nod to begin expanded access program for OCU400 in retinitis pigmentosa

## Summary
- FDA approved expanded access program for OCU400 for adult RP patients 18+ with minimal retinal preservation.
- OCU400 is a modifier gene therapy; positive Phase 1/2 data and ongoing Phase 3 liMeliGhT trial.
- RP affects ~300,000 in US/Europe, 1.6M globally; EAP provides access before BLA approval.
- Targets BLA and MAA approval in 2026; OCU400 has orphan drug and RMAT designations from FDA.

## SEC filing metadata
- accession: 0001104659-24-085603
- form_type: 8-K
- ticker: OCGN
- cik: 0001372299
- company_name: Ocugen, Inc.
- filed_at: 2024-08-05T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1372299/000110465924085603/0001104659-24-085603-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1372299/000110465924085603/tm2420843d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-24-085603
- JSON: https://secwatch.observer/filing/0001104659-24-085603.json
- Plain text: https://secwatch.observer/filing/0001104659-24-085603.txt

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