Ocugen, Inc. Announces Removal of Clinical Hold on Investigational New Drug Application for OCU200 Phase 1 Clinical Trial

Core Viewpoint - Ocugen, Inc. has announced the lifting of the clinical hold by the FDA on its investigational new drug application for OCU200, a treatment for diabetic macular edema (DME) [1] Company Overview - Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines [5] - The company aims to improve health and offer hope for patients globally through innovative scientific approaches [5] Clinical Trial Details - The Phase 1 clinical trial for OCU200 is designed to treat patients with DME, targeting the underlying disease mechanisms through the integrin pathway [2][3] - The trial will be a multicenter, open-label, dose-ranging study with three cohorts assessing the safety of OCU200, and a fourth cohort combining OCU200 with anti-VEGF therapy [3] Disease Context - DME is a common vision-threatening disease affecting approximately 746,000 people in the United States, characterized by blurriness and progressive vision loss [4] - The prevalence of DME is increasing due to the rising number of diabetes cases in the U.S., making it crucial to address this condition [3] Future Indications - Ocugen intends to explore additional indications for OCU200, potentially treating diabetic retinopathy and wet age-related macular degeneration, which together affect nearly nine million Americans [4]