Trial Profile

A Phase 2/3 pivotal confirmatory clinical trial for OCU410ST

Status: Planning

Phase of Trial: Phase II/III

Latest Information Update: 23 Jun 2025

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At a glance

16 Jun 2025 According to an Ocugen media release, company announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) amendment to initiate a Phase 2/3 pivotal confirmatory trial of OCU410ST.
27 May 2025 According to an Ocugen media release, company plans to initiate the Phase 2/3 pivotal confirmatory trial in the next few weeks.
08 Apr 2025 According to an Ocugen media release, Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-founder of Ocugen will participate in a panel addressing the journey of commercializing Advanced Therapy Medicinal Products (ATMPs) including OCU400 for retinitis pigmentosa, OCU410 for geographic atrophy and OCU410ST for Stargardt disease, at the 2025 Cell & Gene Meeting on the Mediterranean being held April 15-17, 2025 at the Rome Cavalieri in Rome, Italy.

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