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Lineage Reports 3-Year GA Data Showing Vision Gains, Retinal Improvement

Data from the study revealed gains in BCVA of +9 letters at 36 months among patients with extensive coverage of OpRegen cell therapy to the GA lesion site.

Ophthalmology Management May 4, 2026

Lineage Cell Therapeutics announced that 36-month results from patients enrolled in a phase 1/2a clinical study of RG6501 (OpRegen) in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD), were presented at the Foundation Fighting Blindness’ Retinal Therapeutics Innovation Summit 2026. 

The presentation, "Retinal Pigment Epithelium (RPE) Cell Therapy in Geographic Atrophy Secondary to Age-related Macular Degeneration: 3 Year Results from the Phase 1/2a Study," was presented by Eyal Banin, MD, PhD, of Hadassah-Hebrew University Medical Center on behalf of Roche and Genentech.

RG6501 (OpRegen) is a suspension of human allogeneic retinal pigment epithelial (RPE) cells currently in development for the treatment of GA secondary to AMD. Subretinal delivery of OpRegen cell therapy has the potential to counteract RPE cell loss in areas of GA lesions by supporting retinal cell health and improving retinal structure and function. It is being developed under an exclusive worldwide collaboration between Lineage, Roche, and Genentech, a member of the Roche Group, and is currently being evaluated in a phase 2a clinical study, GAlette, in patients with GA secondary to AMD, Lineage Cell Therapeutics said in a press release. 

The following data was highlighted at the Retinal Innovation Summit: 

  • Gains in best corrected visual acuity (BCVA) in patients in Cohort 4 (less advanced GA than in other cohorts) were presented at 12 months (primary endpoint), 24 months, and have now persisted through 36 months following subretinal administration of OpRegen cell therapy. 

  • Mean change in BCVA among treated eyes for Cohort 4 patients (n=10) completing 3-year follow up was +6.2 letters (compared to +5.5 letters at 24 months) (Early Treatment Diabetic Retinopathy Study (ETDRS) assessment). 

  • Effects were greater on average in the 5 Cohort 4 patients with extensive OpRegen cell therapy coverage of atrophic areas at the time of surgical delivery—in these patients’ treated eyes, the mean change in BCVA was +9.0 ETDRS letters for those completing 3-year follow-up (compared to +7.4 ETDRS letters at 24 months) (n=5).

  • Sustained evidence of retinal structural improvement by a quantitative optical coherence tomography (OCT) analysis through 36 months was observed in treated eyes of Cohort 4 patients following a single subretinal administration of OpRegen cell therapy. 

  • At month 36, sustained evidence of retinal structure improvements in external limiting membrane (ELM) and RPE complex (RPE-C) layers on OCT was observed in the subgroup of 5 patients in Cohort 4 with extensive OpRegen cell therapy bleb coverage of atrophic areas at the time of surgical delivery. Mean improvement of RPE-C area compared with baseline was maintained in treated eyes from 24 months (+2.6 mm2; n=4) to 36 months (+1.9 mm2; n=5). In comparison, mean change in RPE-C area decreased in untreated fellow eyes from 24 months (-2.8 mm2; n=4) to 36 months (-3.8 mm2; n=5). Mean change in ELM area was maintained in treated eyes from 24 months (+0.8 mm2; n=4) to 36 months (+0.3 mm2; n=5). In comparison, mean change in ELM area decreased in untreated fellow eyes from 24 months (-1.9 mm2; n=4) to 36 months (-3.4 mm2; n=5).

  • Imaging evidence of structural benefit and greater gains in visual acuity were seen in study eyes in Cohort 4 patients at month 12, continuing through month 36.

  • Differences as compared with fellow eyes increased over time, suggesting possible modification of the course of disease. 

  • Quantitative OCT improvements in RPE-C and ELM area and the gains in BCVA were more prominent in patients with extensive compared with limited OpRegen bleb coverage of GA. 

  • Quantitative analysis of OCT imaging revealed areas with partial restoration of outer retinal structure including re-appearance of an RPE layer as well as features associated with recovery of photoreceptors. 

According to Lineage Cell Therapeutics, these data suggest that OpRegen cell therapy may counteract RPE cell dysfunction and loss in GA by providing support to remaining retinal cells, and these effects appear durable through at least 36 months after a single administration.