Ocugen Announces Phase 3 Confirmatory Clinical Trial Agreement for NeoCart


MALVERN, PA — Ocugen, Inc. (NASDAQ: OCGN) announced that the U.S. Food & Drug Administration (FDA) recently 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.

“We are eager to get started on the final phase of NeoCart® development and pleased at the outcome of our discussions with the FDA,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen. “With this guidance, Ocugen has a clear path forward for the first candidate in our regenerative cell therapy program.”

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 cm2.

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.

Earlier this year, the FDA granted a regenerative medicine advanced therapy (RMAT), designation to NeoCart®. NeoCart® combines breakthroughs in bioengineering and cell processing to enhance the autologous cartilage repair process by merging a patient’s own cells with a fortified 3-D scaffold designed to accelerate healing and reduce pain.

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