MALVERN, PA — Ocugen, Inc. (NASDAQ: OCGN) this week announced a pivotal development as the FDA lifted the clinical hold on its investigational drug application for OCU200.
This decision allows Ocugen to commence a Phase 1 clinical trial aimed at treating diabetic macular edema (DME), a condition affecting approximately 746,000 Americans. OCU200, a recombinant fusion protein combining tumstatin and transferrin, targets the integrin pathway to address disease mechanisms underlying DME.
Dr. Arun Upadhyay, Chief Scientific Officer at Ocugen, expressed optimism, stating, “OCU200 holds promise to provide benefits to all DME patients, including non-responders to currently approved therapy.” The trial will assess the safety and efficacy of OCU200, especially for those resistant to existing anti-VEGF treatments.
Dr. Huma Qamar, Ocugen’s Chief Medical Officer, highlighted the urgency of addressing DME. “With the rising prevalence of diabetes in the U.S., the need to tackle DME becomes more critical,” she said.
The company also explores OCU200’s potential in treating diabetic retinopathy and wet age-related macular degeneration, conditions impacting nearly nine million Americans.
This innovative approach aims to improve treatment outcomes for patients suffering from these sight-threatening disorders.
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