Pharma Focus Asia

Ocugen, Inc. Announces U.S. FDA Submission of Investigational New Drug Application

Monday, February 27, 2023

Ocugen announced that 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, a fusion protein with a distinct mechanism of action (MOA), for the treatment of diabetic macular oedema (DME). This regulatory milestone fulfils 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.

DME is one of the most common vision-threatening diseases occurring in people with diabetes and includes blurriness in vision and progressive vision loss as the disease progresses. Approximately 745,000 people in the United States are affected with DME, and this number is expected to further increase as the number of people with diabetes increases.

The potential for OCU200 provides a new treatment option for the significant percentage of people living with DME, including non-responders to the current standard of care.

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