MALVERN, PA — Ocugen, Inc. (Nasdaq: OCGN) reported fourth quarter and full-year 2025 financial results and provided updates on its clinical pipeline, including completion of enrollment for a Phase 3 gene therapy trial targeting retinitis pigmentosa.
The company said enrollment is complete for the Phase 3 liMeliGhT trial evaluating OCU400, a gene therapy candidate for retinitis pigmentosa, a group of inherited retinal diseases that cause progressive vision loss.
Ocugen said the one-year study enrolled 140 patients and topline data are expected in the first quarter of 2027, which the company plans to use to support a Biologics License Application filing and potential regulatory approval.
Chief Executive Officer Shankar Musunuri said the company advanced multiple programs during 2025.
“Considerable development across all our modifier gene therapy programs, notable licensing and financing agreements to strengthen our financial position, and meaningful appointments to our leadership team made 2025 a transformative year for Ocugen,” Musunuri said.
The company also reported progress in its OCU410ST program for Stargardt disease, a rare inherited retinal disorder.
Ocugen said enrollment in the Phase 2/3 GARDian clinical trial is nearing completion, with interim data expected in the third quarter of 2026 and topline results anticipated in the second quarter of 2027.
For OCU410, a gene therapy candidate for geographic atrophy associated with dry age-related macular degeneration, Ocugen reported preliminary Phase 2 data showing reduced lesion growth compared with control eyes.
The company said complete Phase 2 data from the ArMaDa trial are expected in March 2026.
Ocugen also reported a regional licensing agreement with Kwangdong Pharmaceutical Co., Ltd. for Korean rights to OCU400.
The company said the agreement includes upfront fees, development milestone payments, and royalties.
Ocugen reported research and development expenses of $10.7 million for the fourth quarter of 2025, compared with $8.3 million in the same period in 2024.
General and administrative expenses were $6.1 million for the quarter, compared with $6.3 million a year earlier.
The company reported a net loss of $0.06 per share for the quarter, compared with a loss of $0.05 per share in the prior-year period.
For the full year, research and development expenses totaled $39.8 million, compared with $32.1 million in 2024.
General and administrative expenses were $27.6 million for 2025, compared with $26.7 million in the previous year.
Ocugen reported a full-year net loss of $0.23 per share, compared with a loss of $0.20 per share in 2024.
The company said it had $18.9 million in cash and restricted cash as of December 31, 2025.
Ocugen said proceeds from a $22.5 million financing completed in January 2026 are expected to fund operations into the fourth quarter of 2026, with potential extension into the second quarter of 2027 if outstanding warrants are exercised.
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