A single administration of an allogeneic retinal pigment epithelium (RPE) cell therapy was associated with sustained anatomic and functional signals through 36 months in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD), according to data presented at the Retinal Therapeutics Innovation Summit 2026.
In a phase 1/2a study, investigators reported outcomes for RG6501 (OpRegen). The presentation was delivered by Eyal Banin, MD, PhD, on behalf of collaborators Roche/Genentech and Lineage Cell Theraputics. The therapy consists of subretinally delivered human allogeneic RPE cells designed to support areas of atrophy.
Among patients in cohort 4 with less advanced disease, mean best-corrected visual acuity (BCVA) gains were maintained through 3 years. In treated eyes completing 36-month follow-up (n=10), mean BCVA improved by +6.2 ETDRS letters, compared with +5.5 letters at 24 months. In a subgroup with extensive bleb coverage of atrophic areas at the time of surgery (n=5), mean gains reached +9.0 letters at 36 months.
Structural outcomes on optical coherence tomography also showed divergence from untreated fellow eyes over time. Treated eyes demonstrated maintained improvements in RPE complex and external limiting membrane areas through 36 months, whereas fellow eyes continued to decline. Imaging analyses further suggested partial restoration of outer retinal features, including reappearance of an RPE layer and signals consistent with photoreceptor recovery.
Differences between treated and untreated eyes increased over time, findings that investigators said may indicate modification of disease course. Effects were more pronounced in eyes with broader coverage of atrophic regions at the time of delivery.
RG6501 is currently being evaluated in the phase 2a GAlette study, which is enrolling patients and assessing surgical delivery approaches and device optimization for subretinal administration. RP







