Ocugen Inc (NASDAQ:OCGN) shares are trading higher by 7.7% to $1.97 during Monday’s session after the company announced U.S. FDA clearance of the IND amendment to initiate a Phase 3 clinical trial of OCU400.
The trial will enroll 150 participants, divided into two arms, focusing on individuals with the RHO gene mutation and those with gene-agnostic RP. Utilizing an updated mobility assessment tool called LDNA, the trial aims to assess the therapy’s efficacy across various disease stages.
With orphan drug and RMAT designations already secured, Ocugen targets BLA approval for OCU400 by 2026. The company says this offers potential hope to the approximately 110,000 RP patients in the United States and 1.6 million worldwide.
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