secwatch.observer — SEC 8-K summary
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Issuer:     Ocugen, Inc. (OCGN)
CIK:        0001372299
Form:       8-K
Filed at:   2026-01-15T23:59:59+00:00
Accession:  0001104659-26-003900
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Ocugen: OCU410 shows 46% GA lesion reduction in Phase 2; Phase 1 EZ loss 60% slower
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- Phase 2 preliminary 12-month data (N=23) shows 46% GA lesion growth reduction vs control (p=0.015); medium dose 54% (p=0.02), high dose 36% (p=0.05).
- Subgroup with baseline ≥7.5 mm² (N=14) demonstrated 57% reduction in lesion size vs control.
- Phase 1 (N=7 evaluable) shows 60% slower ellipsoid zone loss in treated eyes vs untreated fellow eyes at 12 months.
- No OCU410-related serious adverse events reported across Phase 1 and Phase 2; no endophthalmitis, retinal detachment, or vasculitis.
- Company plans full Phase 2 data later Q1 2026, initiate Phase 3 in 2026, and BLA filing in 2028.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1372299/000110465926003900/0001104659-26-003900-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1372299/000110465926003900/tm263269d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-003900

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