A Phase 1 Study To Assess The Safety And Efficacy Of OCU200 For Center-Involved Diabetic Macular Edema
Latest Information Update: 17 May 2024
At a glance
- Drugs OCU 200 (Primary)
- Indications Diabetic macular oedema
- Focus Adverse reactions
- Sponsors Ocugen
- 15 May 2024 According to a Ocugen media release, company continues to work with FDA to address comments to lift the clinical hold.
- 05 May 2023 According to a Ocugen media release, In April, the IND was placed on clinical hold by the FDA prior to initiating the Phase 1 trial and the company plans to respond to the FDA promptly to get FDA clearance to initiate the Phase 1 trial.
- 27 Feb 2023 According to an Ocugen media release, the company 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 for the treatment of diabetic macular edema (DME).