Ocugen "announced that it has submitted an Investigational New Drug application with the FDA to initiate a Phase 1 clinical trial of OCU200, a fusion protein with a distinct mechanism of action (MOA), for the treatment of diabetic macular edema. This regulatory milestone fulfills the Company’s commitment to file the IND for OCU200 within the first quarter of 2023. The planned Phase 1 clinical study will assess the unilateral intravitreal administration of OCU200 alone or in combination with an approved anti-VEGF therapy in participants with DME. This is a multicenter, open-label, dose-ranging study with 3 cohorts in the dose-escalation portion of the study and 1 cohort in the combination therapy portion of the study."
Published first on TheFly
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