Advancement of Gene Therapy Programs
OCU400 nearing Phase 3 enrollment completion and OCU410ST Phase 2/3 trial is ahead of schedule. Anticipated BLA submission for OCU410ST in the first half of 2027.
Positive Regulatory Progress
European Medicines Agency confirmed the acceptability of a single U.S.-based trial for submission of MAA in Europe for OCU410ST, maintaining timeline and budget efficiencies.
Strategic Partnerships and Financial Position
Exclusive licensing agreement with Kwangdong Pharmaceutical for OCU400 in South Korea, with potential sales milestones and royalty agreement. Recent $20 million financing extends runway into 2026.
Promising Clinical Data
OCU410 Phase 1 study showed a 23% reduction in lesion growth and visual acuity improvements. OCU410ST showed a 48.2% reduction in lesion growth in Phase 1 subjects.