Lineage Cell Therapeutics, Inc. 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 Clinical Trials at the Summit (CTS) 2025. 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.
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 (less advanced GA than in other cohorts) 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 drusen complex (RPEDC) layers on OCT was observed in the subgroup of five patients in Cohort 4 with extensive OpRegen cell therapy bleb coverage of atrophic areas at the time of surgical delivery; Mean improvement of RPEDC 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 RPEDC area decreased in untreated fellow eyes from 24 months (-2.8 mm2; n=4); n=5); Mean change in ELM area was maintained in treated eyes from24 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 by 24 months (-1.9 mm2;n=4) to 36 months (-3.8 mm2; n =5); In comparison, mean Change in ELM area decreased in treated eyes from 24 months (-1.9mm2; n=5); in comparison, mean change in EL M area decreased in untreated fellow eyesfrom 24 months (-1.9 g2; n=4) To 36 months (-3.4 mm2; n=5; These data suggest that OpRegen cell therapy may counteract RPE cell dysfunction and loss in GA by providing support to the remaining retinal cells within atrophic areas, and these effects appear durable through at least 36 months after a single administration; The Phase 2a "GAlette study" evaluating the success of subretinal delivery of OpRegan cell therapy to target areas of GA is currently enrolling (NCT05626114); In addition to evaluating other surgical parameters, this study will test proprietary surgical devices in development for subretinal delivery of Op Regen cell therapy that have potential advantages over currently available devices and procedures. Dr. Riemann's presentation is now available on the Events and Presentations section of Lineage's website.
Clinical Trials at the Summit (CTS) 2025 brings together a diverse group of experts from around the world to discuss ongoing clinical trials and the latest data, all with the goal of achieving advances in vitreoretinal care. This program will explore the partnerships and strategies required to design and execute effective clinical trials. From this platform, Lineage designs, develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or identical to cells found naturally in the human body.
Such forward-looking statements include, but are not limited to, statements relating to: the potential therapeutic benefits of OpRegen cell therapy may counter RPE cell dysfunction and loss In addition to the remaining retinal cells and loss in GA by providing supporting retinal cells within atrophic area.
