Key Takeaways

• RG6501 (OpRegen) cell therapy shows sustained visual acuity and retinal structure improvements in GA patients over 36 months.
• Extensive coverage of OpRegen therapy leads to greater BCVA and retinal structure improvements, persisting through month 36.
• Cohort 4 patients with less advanced GA experienced significant BCVA gains, with a mean change of +6.2 ETDRS letters at 36 months.
• Quantitative OCT analysis revealed sustained retinal structural improvements in treated eyes, contrasting with deterioration in untreated eyes.
• The ongoing phase 2a GAlette study aims to optimize OpRegen delivery for GA secondary to AMD, with further insights anticipated.

New findings reveal RG6501 cell therapy shows promising long-term visual improvements for geographic atrophy patients.

Lineage Cell Therapeutics recently announced 36-month results from a phase 1/2a clinical study (NCT02286089) of RG6501 (OpRegen) for the treatment of geographic atrophy (GA), secondary to age-related macular degeneration (AMD).¹

On behalf of Roche and Genentech, Christopher D. Riemann, MD, Vitreoretinal Surgeon and Fellowship Director, Cincinnati Eye Institue and University of Cincinnati School of Medicine, presented the data at the Clinical Trials at the Summit (CTS) 2025 in a presentation titled, “OpRegen Retinal Pigment Epithelium (REP) Cell Therapy for Patients with Geographic Atrophy (GA): Month 30 Results from the Phase 1/2a Trial.”

RG6501 is “a suspension of human allogeneic retinal pigment epithelial (RPE) cells” in development for the treatment of GA, a press release said. Through subretinal delivery, the cell therapy has the potential to support retinal cell health and improve retinal structure and function, counteracting RPE cell loss in GA lesions.

“Long-term clinical outcomes following a single administration of OpRegen cell therapy is challenging the long-held view that GA causes irreversible damage,” said Brian M. Culley, Lineage CEO, in a press release. “A key finding from the Lineage-run phase 1/2a trial was the importance of extensive placement of cells around the area of atrophy. Among patients who received fulsome coverage by OpRegen cell therapy, anatomical and functional benefits from a single administration have lasted at least 3 years.”

Read More: rb.gy/nks38r

Source: Ophthalmology Times

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