MALVERN, PA — Ocugen (NASDAQ: OCGN) reported positive mid-stage clinical data for its geographic atrophy gene therapy program while raising additional capital expected to fund operations into 2028 as the company advances multiple late-stage blindness-disease programs toward regulatory filings.
Twelve-month Phase 2 data for OCU410 showed a statistically significant 31% reduction in lesion growth in patients with geographic atrophy secondary to dry age-related macular degeneration at the dose selected for Phase 3 development.
The company also reported preservation of the ellipsoid zone — a retinal structure correlated with visual function — and said about 20% of treated patients showed no disease progression during the study period.
Ocugen plans to begin a Phase 3 registrational trial for OCU410 in the third quarter of 2026 and indicated the study could support a combined U.S. and European regulatory strategy involving about 300 subjects.
The company completed enrollment for two additional late-stage gene therapy programs during the quarter, including OCU400 for retinitis pigmentosa and OCU410ST for Stargardt disease.
Enrollment in the Phase 3 liMeliGhT trial for OCU400 reached 140 subjects, while the GARDian3 confirmatory trial for OCU410ST completed enrollment and dosing of 63 patients ahead of schedule.
Ocugen expects topline Phase 3 data for OCU400 in the first quarter of 2027 and plans to begin a rolling Biologics License Application submission in the third quarter of 2026.
Topline results for OCU410ST are expected in the second quarter of 2027, with a planned BLA submission by mid-2027.
The company also announced a private offering of $115 million in convertible senior notes due 2034, with an option that could increase the offering size to $130 million if fully exercised.
Ocugen expects the financing to increase cash, cash equivalents, and restricted cash to about $112.1 million following closing, including repayment of Avenue debt carrying a 12.5% interest rate.
The company intends to use about $32.7 million of proceeds to retire that debt.
Chief Executive Officer Shankar Musunuri said the company completed enrollment in two late-stage programs during the first months of 2026 while preparing for its first BLA submission and a registration trial in dry AMD.
“We are executing well against our plans with the highest productivity per employee rate compared to our peers, adequate cash runway with the recent offering, and key milestone achievement to create long-term value creation for our patients and shareholders,” Musunuri stated.
Ocugen reported cash, cash equivalents, and restricted cash of $32.2 million at March 31, compared with $18.9 million at year-end 2025.
First-quarter operating expenses increased to $19.4 million from $16.0 million a year earlier, reflecting higher research, development, and administrative costs.
The company posted a net loss of $0.06 per share for the quarter, compared with a net loss of $0.05 per share in the prior-year period.
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