Ocugen (OCGN) Announces New Cell Therapy Program Following FDA Regenerative Medicine Advanced Therapy (RMAT) Recognition

Ocugen, Inc. (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene therapies, biologicals, and vaccines, today announced that it is diversifying its innovative pipeline by introducing a Phase 3, cell therapy platform technology called NeoCart® (autologous chondrocyte-derived neocartilage). Recently, the U.S. Food and Drug Administration (FDA) granted a Regenerative Medicine Advanced Therapy (RMAT) designation to NeoCart® for the repair of full-thickness lesions of the knee cartilage in adults.

NeoCart® is a three-dimensional tissue-engineered disc of new cartilage that is manufactured by growing chondrocytes – the cells responsible for maintaining cartilage health – derived from the patient on a unique scaffold. NeoCart® has the potential to accelerate healing and reduce pain by rebuilding a patient’s damaged knee cartilage. It treats pain at the source, creating a similar, functional joint surface as it was before the injury. Ultimately, the goal is to prevent a patient’s progression to osteoarthritis. NeoCart® was acquired as a part of Ocugen’s reverse merger with the original developer of the therapy, Histogenics, in 2019.

“We’re excited that NeoCart® has received this RMAT designation, an important regulatory milestone, especially as we view this product as an enabling technology in cell and regenerative therapy for orthopedic indications. Our next step will be working with the FDA to construct the Phase 3 program to bring this innovation to this emerging treatment area,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder, Ocugen, Inc. “People living with articular cartilage lesions literally have holes in their knees that are extremely difficult to heal, and without proper treatment, they’re at high risk of getting osteoarthritis. We believe that NeoCart® offers the potential for an innovative new option where treatments in this area are still limited and results are not optimal.”

The Regenerative Medicine Advanced Therapy (RMAT) designation is part of the 21st Century Cures Act. The program was created to expedite the development and review of regenerative medicine therapies intended to treat, modify, reverse or cure a serious condition. Receiving an RMAT designation offers sponsor companies all the benefits of the fast track and breakthrough therapy designation programs, including early interactions with the FDA. Ocugen is working with the FDA to finalize the Phase 3 protocols necessary to advance the clinical development program of NeoCart® required for eventual market authorization. Articular cartilage lesions are a serious and often mobility-limiting condition. When the cartilage is healthy, it makes movement easy, allowing the bones to glide over each other with very little friction, but it can be damaged by injury or normal wear and tear. Cartilage that is damaged can, over time, cause pain and reduce one’s ability to function. Small articular lesions have a limited capacity to self-repair, and full thickness injuries have no ability to naturally heal. There are no blood vessels or nerves to support healing, and as cartilage matures, chondrocytes have limited ability to replicate. Untreated damage eventually can lead to osteoarthritis.

Details of the NeoCart® development program will be shared at a future date.

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