MALVERN, PA — Ocugen, Inc. (NASDAQ: OCGN) has reported its first-quarter 2025 financial results and shared updates on its growing pipeline of gene therapy treatments aimed at combating significant unmet medical needs.
The company achieved progress across its gene therapy portfolio, with its OCU400 Phase 3 trial for retinitis pigmentosa (RP) moving steadily toward potential Biologics License Application (BLA) and Marketing Authorization Application (MAA) filings by mid-2026. Dr. Shankar Musunuri, Ocugen’s Chairman, CEO, and Co-Founder, stated, “We remain steadfast in our mission to provide a one-time therapy for life to address considerable unmet medical needs that exist for millions of patients facing the terrifying prospect of losing their vision.”
Other pivotal developments include the upcoming launch of OCU410ST’s Phase 2/3 study for Stargardt disease this summer, with plans for a 2027 BLA submission. For geographic atrophy (GA), the Phase 2 portion of the clinical trial for OCU410 is complete ahead of schedule, showcasing promising 12-month results, including a 23-letter gain in visual acuity and slower lesion growth in treated eyes.
Additionally, Ocugen shared positive Phase 1/2 long-term data for OCU400, which demonstrated consistent safety and significant improvements in visual function for RP patients, reinforcing the therapy’s ability to address RP across various genetic mutations.
The company’s gene therapy platform further received solid endorsements, as the European Medicines Agency (EMA) granted Advanced Therapy Medicinal Product (ATMP) classification for OCU400, OCU410ST, and OCU410, expediting regulatory timelines in Europe while underscoring their potential as groundbreaking treatments.
On the financial front, Ocugen reported $38.1 million in cash and restricted cash at the end of Q1 2025, extending its cash runway through early 2026. Total operating expenses stood at $16.0 million during the quarter, including $9.5 million in R&D investments to advance its pipeline.
The company also initiated Phase 1 trials for OCU200 to treat diabetic macular edema and expects to complete the study later this year. Furthermore, the Investigational New Drug application for OCU500 is active, with a Phase 1 trial planned for mid-year.
With multiple milestones on the horizon, Dr. Musunuri added, “We have had a strong start to 2025 and are approaching considerable milestones in the next few months…with a clear and precise business strategy to operate efficiently in service of our patients and shareholders.”
Ocugen’s strategic progress continues to position it as a leader in delivering innovative gene therapy solutions to address critical unmet needs in ocular diseases globally.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.