Ocugen: FDA Agrees To Proposed Control, Overall Design For Phase 3 Study Of NeoCart

(RTTNews) - Ocugen, Inc. (OCGN) announced the FDA agreed to the company's proposed control and overall design for the Phase 3 study of NeoCart, a regenerative cell therapy for the repair of full-thickness lesions of the knee cartilage in adults. The Phase 3 study will be a randomized, controlled trial to show the superiority over standard of care, chondroplasty, in subjects with articular cartilage defects.

Earlier in the current year, the FDA granted a regenerative medicine advanced therapy designation to NeoCart.

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