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Lineage Cell Therapeutics announced promising 36-month results from their Phase 1/2a clinical study of RG6501 (OpRegen®) for geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Key findings include:
- Visual Acuity Improvements: Cohort 4 patients (less advanced GA) showed sustained improvement through 36 months, with mean BCVA gains of +6.2 letters overall and +9.0 letters in patients with extensive OpRegen coverage
- Structural Improvements: Sustained retinal structural improvements observed through OCT analysis, with treated eyes maintaining RPEDC area (+1.9 mm²) while untreated eyes declined (-3.8 mm²)
- Current Development: A Phase 2a "GAlette" study (NCT05626114) is actively enrolling patients, testing new proprietary surgical devices for OpRegen delivery
The therapy is being developed through a worldwide collaboration between Lineage, Roche, and Genentech. Results suggest OpRegen cell therapy may provide durable support to remaining retinal cells within atrophic areas for at least 36 months after a single administration.