Lineage Cell Therapeutics’ OpRegen holds potential to become new treatment option for GA
Lineage Cell Therapeutics’ OpRegen (RG6501) is gaining attention as a promising one-time allogenic cell therapy for geographic atrophy (GA), following encouraging results from its Phase I/IIa trial. OpRegen’s ability to improve and stabilize vision positions it as a potential breakthrough in addressing a critical unmet need in GA management, says GlobalData, a leading data and analytics company.
The current GA treatment landscape in the US consists of only two therapies, Syfovre (pegcetacoplan) and Izervay (avacincaptad pegol).
Suspension of embryonic stem cell-derived RPE cells
OpRegen is a suspension of embryonic stem cell-derived retinal pigment epithelial (RPE) cells and works by restoring retinal function through targeted replacement of dysfunctional retinal pigment epithelium (RPE) cells, reestablishing the essential photoreceptor-RPE cellular interface, thereby restoring visual function in degenerative retinal pathologies. This cell therapy is a subretinal injection.
OpRegen is being developed under an exclusive worldwide collaboration between Lineage, Roche, and Genentech, a member of the Roche Group.
Long-term data from the completed Phase I/IIa trial demonstrated that throughout the study duration, at months 12, 24 and 36, functional and anatomical benefits have persisted; mean BCVA scores recorded were consistently above the baseline, proving its durability; and it proved able to stabilize and improve GA. Patients who completed the three-year follow-up (n=10) presented with a mean increase in BCVA of 6.2 letters (Early Treatment Diabetic Retinopathy Study [ETDRS]).
Potential to alleviate treatment burden
Sara Reci, MSc, Managing Pharma Analyst at GlobalData, comments: “These findings highlight OpRegen’s potential to alleviate treatment burden, an imperative factor in the management of patients with GA.”
3-year data on 12 patients
In an article in Retinal Physician, Christopher D. Riemann, MD, a principal investigator for the trial who presented the data at the 2025 Clinical Trials at the Summit meeting in Las Vegas, comments: “These cells are showing incredible promise to restore and recover vision in dry age-related macular degeneration (AMD) patients with GA.” At the same time, however, he cautions readers of the journal not to set expectations too high: “This is buzzworthy, but we’re talking about small numbers—it’s 3-year data on 12 patients. That does not equate to, ‘We’ve got a cure!’ How many phase 1 treatments have looked amazing and then failed in phase 2 or 3. But this is really cool, really exciting data and I can’t wait to see where it goes next.”
Sources: GlobalData / Retinal Physician