NeoCart was previously evaluated in a phase 3 trial (NCT01066702) by Histogenics, a company that later merged withOcugen in 2019. 7 The trial evaluated NeoCart in comparison to microfracture, but failed to meet its primary end point. 8 In subsequent discussions with the FDA, the agency indicated that while some of the data from the trial was compelling, a new phase 3 clinical trial would be needed before it would accept a biologics license application for filing. Ocugen now intends to submit an investigational new drug amendment for the initiation of the new trial in late 2023 or early 2024. 5 Ocugen also announced that a new current Good Manufacturing Practice cell therapy manufacturing facility is under construction that will support clinical and commercial production of NeoCart. REFERENCES 1. Ocugen announces OCU400 receives orphan drug designations for retinitis pigmentosa and leber congenital amaurosis. News release.