Ocugen Announces Phase 3 Confirmatory Clinical Trial Agreement for NeoCart®
Ocugen, Inc. announced the FDA's approval of its Phase 3 study design for NeoCart®, a regenerative cell therapy aimed at repairing knee cartilage lesions in adults. This crucial step follows their pipeline expansion initiative from May 2022. The randomized trial seeks to demonstrate NeoCart's superiority over existing treatments. Additionally, Ocugen is establishing a Good Manufacturing Practice facility and aims to file an Investigational New Drug amendment by late 2023 or early 2024. The FDA previously designated NeoCart® as a regenerative medicine advanced therapy.
- FDA approval for Phase 3 study design of NeoCart®.
- Plans to establish Good Manufacturing Practice facility for NeoCart®.
- The FDA granted regenerative medicine advanced therapy designation to NeoCart®.
- None.
Important next step for Ocugen’s regenerative cell therapy in orthopedics since announcing pipeline expansion in May 2022
MALVERN, Pa., Dec. 16, 2022 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that the U.S. Food & Drug Administration (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.
“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.
About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.
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Contact:
Tiffany Hamilton
Head of Communications
IR@ocugen.com
FAQ
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