Ocugen, Inc. OCGN
Ocugen, Inc. (Nasdaq: OCGN) is an ophthalmology drug developer. Its lead program, OCU400, is in Phase 3 for Retinitis pigmentosa (gene-agnostic, early to late stage). Its next catalyst on record is OCU410: OCU410 BLA submission targeted for 2028 for geographic atrophy. (2028).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: OCU410 — OCU410 BLA submission targeted for 2028 for geographic atrophy. (2028). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| OCU400 (liMeliGhT Phase 3, N=140, enrollment complete) | Retinitis pigmentosa | gene therapy | Phase 3 |
| OCU410ST (GARDian3 Phase 2/3 pivotal, dosing complete N=63) | Stargardt disease (ABCA4 retinopathies) | gene therapy | Phase 3 |
| OCU410 (ArMaDa; Phase 3 ArMaDa3 cleared Aug 2026) | Geographic atrophy secondary to dry AMD | gene therapy | Phase 2 |
| OCU200 | Diabetic macular edema, diabetic retinopathy, wet AMD | protein/peptide | Phase 1 |
| OCU500 (inhaled COVID-19 vaccine; NIAID-run Phase 1) | COVID-19 | vaccine | Phase 1 |
Recent results and decisions
- Oct 15, 2026n/a Bahamas regulator (LARTA) granted provisional approval and priority designation of OCU400 for a broad RP indication under an early access program; full approval expected within 90 days.
Bahamas Regulatory Agency, (LARTA1 ), provided provisional approval and priority designation of OCU400
Filing - Oct 15, 2026completed enrollment OCU400 completed Phase 3 enrollment and manufacturing process validation with launch supplies ready.
Enrollment completed; Manufacturing process validation completed; Launch supplies ready
Filing - Oct 15, 2026completed enrollment OCU410ST completed enrollment in Phase 2/3 pivotal trial in 2026.
2026 Enrollment completed
Filing
13 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 ophthalmology companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.