Ocugen Definitive Agreement

Ocugen Definitive Agreement: Everything You Need to Know

Ocugen Inc. (NASDAQ: OCGN) is a clinical-stage biopharmaceutical company that focuses on developing gene therapies and biologics to treat rare and underserved eye diseases. The company has been making significant strides in the field, and its latest move is the signing of a definitive agreement with a leading global contract research organization (CRO), Jubilant HollisterStier LLC (JHS), to manufacture OCU200, Ocugen`s Phase 3 biologic candidate for the treatment of patients with diabetic macular edema (DME).

The agreement signed between Ocugen and JHS outlines a comprehensive manufacturing plan for OCU200, including process transfer, scale-up, clinical and commercial manufacturing, and regulatory support. This deal is a major milestone for Ocugen, marking a critical step toward the commercialization of OCU200 and the expansion of the company`s pipeline.

„We are thrilled to enter into this partnership with Jubilant HollisterStier,“ said Shankar Musunuri, Ph.D., MBA, Chairman, CEO, and Co-Founder of Ocugen. „Their extensive experience and capabilities in biologics manufacturing, along with their commitment to quality, safety, and innovation, make them the ideal partner to help us bring OCU200 to patients with DME.“

DME is a common complication of diabetic retinopathy, a leading cause of blindness in adults. There are currently no approved biologic therapies for DME in the United States, and the market opportunity for OCU200 is significant. The drug has already demonstrated promising results in Phase 2 clinical trials, and the Phase 3 trial is expected to begin in the second half of 2021.

The signing of the definitive agreement is a significant development for Ocugen, but it is not the only one. The company has also recently announced positive results from its Phase 1/2a clinical trial of OCU400, a gene therapy for the treatment of retinitis pigmentosa (RP). RP is a rare, inherited eye disease that causes progressive vision loss, and there are currently no approved treatments.

The results from the Phase 1/2a trial showed that OCU400 was safe and well-tolerated, with no serious adverse events reported. The therapy also demonstrated evidence of biological activity, with improvements in vision observed in some patients. Ocugen plans to advance OCU400 to a Phase 2b trial in the second half of 2021.

Overall, Ocugen is making significant progress in the field of gene therapies and biologics for the treatment of rare and underserved eye diseases. The signing of the definitive agreement with Jubilant HollisterStier for the manufacturing of OCU200 marks a critical step toward the commercialization of the drug, and the positive results from the Phase 1/2a trial of OCU400 provide further validation of the company`s approach. As Ocugen continues to advance its pipeline, it is poised to make a significant impact on the lives of patients with rare and underserved eye diseases.