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Ocugen Gets Positive DSMB Recommendation For OCU400-101 Clinical Trial

Biotechnology company Ocugen, Inc. (OCGN) announced Monday that the independent Data and Safety Monitoring Board (DSMB) for its Phase 1/2 clinical trial of OCU400 recommended that the Company continue enrolling the remaining study subjects in this current cohort at the target dose level.

This recommendation was after reviewing safety data based on dosing to date and recommended that the study proceed with enrolling additional subjects.

OCU400 is the Company's flagship modifier gene therapy candidate for the treatment of Retinitis Pigmentosa (RP).

The OCU400-101 clinical study to assess the safety and efficacy of modifier gene therapy candidate OCU400 for RP resulting from mutations in the nuclear receptor subfamily 2 group E member 3 (NR2E3) and Rhodopsin (RHO) genes recently dosed its first patient.

Ocugen's modifier gene therapy platform targets nuclear hormone receptors (NHRs) that regulate multiple functions within the retina, giving it the potential to address many different gene mutations - and in turn, multiple retinal diseases - with a single product.

Traditional gene therapy, which transfers a functional version of a non-functional gene into target cells, addresses only one individual gene mutation at a time.

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