MALVERN, PA — Ocugen, Inc. (NASDAQ: OCGN) has reported its fourth-quarter and full-year 2024 financial results, alongside significant progress across its clinical programs and regulatory initiatives. The company continues to drive innovation in gene therapy and expand its pipeline to address unmet medical needs in ophthalmology and beyond.
Key Clinical Milestones
Ocugen achieved pivotal advancements with its modifier gene therapy platform. The U.S. Food and Drug Administration (FDA) greenlit a Phase 2/3 pivotal trial for OCU410ST, a treatment aimed at Stargardt disease, potentially accelerating clinical development by up to three years. Results from earlier stages showed a substantial 52% reduction in lesion growth and statistically significant vision improvement in treated eyes.
Additionally, Ocugen’s OCU400 gene therapy for retinitis pigmentosa (RP) continued to show strong results, with two-year data demonstrating durable and statistically significant improvements in vision for 100% of treated subjects. The company remains on track to complete recruitment by mid-2025.
Meanwhile, OCU410 for geographic atrophy (GA) advanced with completed dosing in its Phase 2 ArMaDa trial. Safety profiles for all therapies under development remain favorable, with no serious adverse events reported.
Financial Performance
For 2024, Ocugen reported research and development (R&D) expenses of $32.1 million, down from $39.6 million the previous year. General and administrative expenses totaled $26.7 million compared to $32.0 million in 2023. The company ended 2024 with $58.8 million in cash and expects its current funding to sustain operations into early 2026.
Regulatory Accomplishments
Ocugen secured designations and positive opinions across its portfolio from the European Medicines Agency, bolstering global regulatory support. The company also achieved FDA clearance to initiate trials of OCU500, its COVID-19 inhaled vaccine candidate.
Looking Ahead
Ocugen’s progress in 2024 spotlights its effort to address unmet needs in vision health and beyond. With plans for three potential Biologics License Applications (BLAs) between 2026 and 2028, the company is well-positioned for long-term growth.
CEO Dr. Shankar Musunuri stated that the company’s advancements underscore its dedication to improving patients’ lives through innovative gene therapy solutions. Ocugen looks ahead to making significant clinical and regulatory strides in 2025.
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