Ocugen announced that the U.S. FDA agreed to Ocugen’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 demonstrate the superiority over standard of care, chondroplasty, in subjects with articular cartilage defects. Ocugen plans to enroll subjects with one or two articular cartilage lesions with a total surface area of 1-3 cm. Ocugen is building a current Good Manufacturing Practice cell therapy manufacturing facility to support establishment of the clinical and commercial manufacturing process for NeoCart. The company plans to file an Investigational New Drug amendment to initiate a Phase 3 clinical trial in late 2023/early 2024.
Published first on TheFly
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