MALVERN, Pa. — November 5, 2025 — Leads & Copy — Ocugen Inc. (NASDAQ: OCGN) reported its third-quarter 2025 financial results and provided a business update, noting progress with gene therapies for blindness diseases.
Ocugen’s OCU410ST GARDian3 pivotal confirmatory trial is progressing towards a Biologics License Application filing in the first half of 2027, with 50% enrollment completed. The European Medicines Agency (EMA) accepted a single U.S.-based trial for Marketing Authorization Application submission. Ocugen also executed a licensing agreement with Kwangdong Pharmaceutical for exclusive rights to OCU400 in South Korea and closed a $20 million registered direct offering of common stock and warrants.
The company anticipates $1.5 million in sales milestones for every $15 million in sales in South Korea, with projections to reach $180 million or more in the first 10 years, along with royalties equaling 25% of net sales. Should warrants be exercised, Ocugen anticipates receiving an additional $30 million in gross proceeds. Ocugen CEO Dr. Shankar Musunuri highlighted the progress of two late-stage modifier gene therapies and the company’s commitment to addressing unmet medical needs for patients facing vision loss.
Enrollment nears completion for OCU400 Phase 3 trial. The Committee for Medicinal Products for Human Use of the EMA said a single U.S.-based trial for submission of an MAA for OCU410ST for Stargardt disease is acceptable.
Tiffany Hamilton
AVP, Head of Communications
Tiffany.Hamilton@ocugen.com
Source: Ocugen, Inc.
