Drugs / OCU410
last change Sep 2026 re-read 3 minutes ago

OCU410

Gene therapy (AAV / viral vector)

Developed for
diffuse secondary choroid atrophy
Investigated by
Ocugen

Trials 1

202420252026
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/2 NCT06018558 Feb 2023 → Feb 2026 overdue diffuse secondary choroid atrophy Ocugen Active not recruiting Met primary

News releases announcing trial results or a regulatory action · 8

DateIssuerRelease
2026-07-29 Ocugen Regulatory Ocugen Announces that the U.S. Food and Drug Administration Has Granted OCU410 Regenerative Medicine Advanced Therapy (RMAT) Designation for Treatment of Geographic Atrophy, Secondary to Dry Age-Related Macular Degeneration ocugen.com ↗
2026-03-24 Ocugen Results Ocugen Announces Topline 12-month Data from Phase 2 ArMaDa Clinical Trial Evaluating OCU410 Modifier Gene Therapy for Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration ocugen.com ↗
2026-01-15 Ocugen Results Ocugen Announces Positive Preliminary Phase 2 Data from OCU410 Modifier Gene Therapy for Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration ocugen.com ↗
2025-03-03 Ocugen Regulatory Ocugen Announces Positive Opinion of EMA’s Committee for Advanced Therapies for ATMP Classification for Novel Modifier Gene Therapy Candidate OCU410 for Geographic Atrophy and OCU410ST for Stargardt Disease ocugen.com ↗
Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that the European Commission has provided a positive opinion from the European Medicines Agency’s (EMA) Committee for Advanced Therapies (CAT) for OCU410 and OCU410ST Advanced Therapy Medicinal Product (ATMP) classification.
2024-12-19 Ocugen Results Data and Safety Monitoring Board Reviews Interim Safety Data of Phase 2 Subjects of OCU410 ArMaDa Clinical Trial for Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration ocugen.com ↗
No serious adverse events (SAEs) related to OCU410 have been reported to date.
2024-11-19 Ocugen Results Ocugen Announces Compelling Preliminary Data for OCU410—a Single Dose Novel Modifier Gene Therapy to Treat Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration ocugen.com ↗
today announced positive preliminary efficacy and safety data from the Phase 1 dose-escalation portion of the Phase 1/2 OCU410 ArMaDa clinical trial for geographic atrophy (GA), secondary to dry age-related macular degeneration (dAMD).
2024-05-31 Ocugen Results Data and Safety Monitoring Board Approves Simultaneous Enrollment in Cohort 3 and Phase 2 Initiation in OCU410 ArMaDa study for Geographic Atrophy ocugen.com ↗
No serious adverse events (SAEs) related to OCU410 have been reported to date in both low- and medium-dose cohorts.
2024-04-05 Ocugen Results Ocugen Announces Positive Data and Safety Monitoring Board Review and Initiation of Enrollment in Medium Dose for OCU410—a Modifier Gene Therapy—in Phase 1/2 ArMaDa Study for Geographic Atrophy ocugen.com ↗
No serious adverse events (SAEs) related to OCU410 have been reported to date.

All press releases naming this drug 17 releases

DateIssuerRelease

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 1 source stands behind the page.

FieldValueCited text
Known as OCU410 ClinicalTrials.gov intervention name — accepted as the source's own label NCT06018558 ↗
Action Restore “OCU410 therapy regulates gene pathways contributing to GA by restoring homeostasis in the eye” NCT06018558 ↗
Modality Gene therapy (AAV / viral vector) “Adeno-associated viral vector 5 human RORA (AAV5-hRORA)” NCT06018558 ↗
Route Other “The drug product is a sterile ophthalmic suspension for subretinal injection” NCT06018558 ↗