MALVERN, PA — Ocugen Inc. (Nasdaq: OCGN) has secured a Middle East and North Africa licensing agreement worth up to $259 million in potential payments and received provisional regulatory approval for its experimental blindness gene therapy in the Bahamas, expanding its international commercialization prospects ahead of pivotal clinical results expected in early 2027.
The Malvern-based biotechnology company reported the developments alongside third-quarter financial results, with $84.6 million in cash, cash equivalents, restricted cash and short-term investments as of Sept. 30, 2026. Ocugen expects its available funding to support operations into 2028.
The international agreements center on OCU400, an investigational gene therapy for retinitis pigmentosa, a group of inherited retinal disorders that cause progressive vision loss.
Under an exclusive licensing agreement with Roots Pharmaceutical covering the Middle East and North Africa, Ocugen is eligible to receive up to $4 million in combined upfront licensing and potential initial development milestone payments.
The agreement also provides for up to $255 million in potential sales-based milestone payments and royalties equal to 22% of net sales. Ocugen will manufacture commercial supplies of OCU400.
The transaction is Ocugen’s second regional licensing arrangement for the therapy, following an earlier agreement with Kwangdong Pharmaceutical in South Korea.
Separately, the Longevity and Regenerative Therapies Board of the Bahamas granted OCU400 provisional approval and priority designation.
Ocugen has entered into an agreement with Global Alliance for Regenerative Medicine, a local partner that will coordinate and manage patient care.
The company is preparing treatment sites and expects to pursue final regulatory approval, with potential patient enrollment beginning as early as the end of 2026.
The regulatory and commercial developments precede a critical clinical milestone for OCU400.
Ocugen expects topline results from its 140-patient Phase 3 liMeliGhT trial during the first quarter of 2027, after which it plans to submit a Biologics License Application to the U.S. Food and Drug Administration.
The company has completed process performance qualification manufacturing batches intended to support the regulatory submission and eventual commercial supply.
OCU400 is one of three late-stage modifier gene therapy programs Ocugen is advancing for retinal diseases.
“With three Phase 3 modifier gene therapy programs underway, Ocugen is executing against a clear strategy of advancing our pipeline and leveraging strategic partnerships to expand global reach and potentially bring our therapies to patients worldwide,” Chairman and Chief Executive Officer Shankar Musunuri stated.
The company’s next major clinical readout is expected to involve OCU410ST, an investigational treatment for Stargardt disease, an inherited retinal condition that causes progressive central vision loss.
Topline results from the 63-patient Phase 2/3 pivotal confirmatory trial are anticipated in the second quarter of 2027, with a planned Biologics License Application submission to follow.
Ocugen has also begun dosing patients in its global Phase 3 ArMaDa3 trial of OCU410 for geographic atrophy, an advanced form of age-related macular degeneration.
The study is designed to enroll 240 participants across the United States, Canada and Europe.
Patients are being randomized in a 2-to-1 ratio to receive either a single subretinal injection of OCU410 or no treatment in the control group.
The trial’s primary endpoint measures growth of geographic atrophy lesions over 12 months, providing a basis for evaluating whether the experimental therapy can slow disease progression.
Ocugen previously presented 12-month results from its Phase 2 ArMaDa2 study at three scientific conferences, including two podium presentations at the American Academy of Ophthalmology’s 2026 meeting.
The company is expanding its European operations to support the OCU410 development program and potential regulatory filings.
Ocugen appointed Jolanda Crombach general manager of its newly established European affiliate in Amsterdam.
Crombach previously served as managing director and board member of Moderna Netherlands and held leadership positions at MSD, also known as Merck, and Pfizer.
Her responsibilities include supporting the Phase 3 program, preparing for potential European marketing authorization submissions and developing commercialization capabilities.
The expansion comes as Ocugen manages the financial demands of conducting three advanced clinical programs while preparing for potential regulatory approvals.
Third-quarter operating expenses totaled $19.7 million, compared with $19.4 million in the corresponding 2025 period.
Research and development expenses increased to $12.5 million from $11.1 million, reflecting the company’s continued investment in its clinical pipeline.
General and administrative expenses declined to $7.2 million from $8.2 million.
Ocugen reported a net loss of 1 cent per common share for the quarter, compared with a loss of 7 cents per share a year earlier.
The company had approximately 339.3 million common shares outstanding as of Sept. 30.
Ocugen’s anticipated funding runway into 2028 extends beyond the expected 2027 clinical readouts for OCU400 and OCU410ST, providing time to advance regulatory submissions and its broader development program.
The next phase of the company’s strategy will center on converting clinical trial results into potential regulatory approvals while developing international commercial partnerships for its retinal gene therapies.
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