Drugs / OCU200
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | diabetic macular edema | 2023-02-27 | “it has submitted an Investigational New Drug application (IND) with the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 clinical trial of OCU200” ocugen.com ↗ |
| Clinical hold | US (FDA) | — | diabetic macular edema | — | “In April, the IND was placed on clinical hold by the FDA” ocugen.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT05802329 | Jan 2024 → Jul 2026 overdue | diabetic macular edema | Ocugen | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2025-03-18 | Ocugen | Results Data and Safety Monitoring Board Reviews Cohort 1 Safety Data and Approves Dosing Cohort 2 in the Clinical Trial of OCU200—a Novel Fusion Protein for Diabetic Macular Edema ocugen.com ↗
No serious adverse events related to OCU200 have been reported to date. |
| 2024-10-09 | Ocugen | Regulatory Ocugen, Inc. Announces Removal of Clinical Hold on Investigational New Drug Application for OCU200 Phase 1 Clinical Trial ocugen.com ↗
Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the investigational new drug application for the Phase 1 clinical trial evaluating OCU200, a recombinant fusion protein consisting of tumstatin and transferrin, for treating diabetic macular edema (DME). |
| 2023-02-27 | Ocugen | Regulatory Ocugen, Inc. Announces Submission of Investigational New Drug Application with U.S. FDA to Initiate a Phase 1 Clinical Trial Evaluating OCU200 for the Treatment of Diabetic Macular Edema ocugen.com ↗ |
| 2021-05-06 | Ocugen | Results Ocugen Presents New Preclinical OCU200 Data at the Association for Research in Vision and Ophthalmology (ARVO) 2021 Annual Meeting ocugen.com ↗
OCU200 inhibited cell proliferation, cell invasion and tube formation by endothelial cells. |
All press releases naming this drug 7 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | OCU200 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05802329 ↗ |
| Route | Intravitreal | “Each subject will receive a total of 2 intravitreal injections of OCU200 6 weeks apart.” NCT05802329 ↗ |