MALVERN, PA

— Ocugen, Inc. (NASDAQ: OCGN) has announced its financial results for the first quarter of 2025 along with advancements in their expanding portfolio of gene therapies designed to address substantial unmet medical requirements.

The firm made strides throughout its collection of gene therapies, particularly as the OCU400 Phase 3 study for retinitis pigmentosa (RP) progressed steadily towards possible BLA and MAA submissions by the middle of 2026. Dr. Shankar Musunuri, who serves as both Chairperson, Chief Executive Officer, and Co-founder at Ocugen, commented, “Our commitment remains unwavering in our aim to offer a single treatment that can last a lifetime to tackle significant unaddressed healthcare demands faced by countless individuals confronting the harrowing possibility of blindness.”

Significant milestones also encompass the scheduled commencement of OCU410ST’s Phase 2/3 investigation into Stargardt disease later this year, aiming for a Biologics License Application submission by 2027. In relation to geographic atrophy (GA), the Phase 2 segment of OCU410’s clinical trial has been completed earlier than anticipated, demonstrating encouraging outcomes from one-year assessments which revealed a 23-letter improvement in visual sharpness along with reduced expansion rates in the treated eye.

Moreover, Ocugen presented favorable Phase 1/2 extended data for OCU400, indicating sustained safety and notable enhancements in visual capability among retinitis pigmentosa (RP) patients. This reinforces the treatment’s potential to tackle RP irrespective of different genetic variations.

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.

In terms of finances, Ocugen stated they had $38.1 million in cash and restricted cash as of the first quarter of 2025, which extends their operational funds into early 2026. The total operating costs for the period amounted to $16.0 million, with $9.5 million allocated towards research and development efforts aimed at progressing their product line.

The firm has kicked off Phase 1 studies for OCU200 aimed at treating diabetic macular edema and anticipates wrapping up these trials by the end of this year. Additionally, the Investigative New Drug application for OCU500 remains valid, with plans set to commence a Phase 1 trial around 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 ongoing strategic advancements continue to cement its role as a frontrunner in providing groundbreaking gene therapy treatments for significant unaddressed needs in global eye disorders.