Results from a Phase I/IIa study of OpRegen (RG6501) show improved retinal structure in patients with geographic atrophy (GA). OpRegen is being developed under an exclusive collaboration between Lineage, Roche, and Genentech for treatment of GA secondary to age-related macular degeneration (AMD).

The study (NCT05626114) is an open-label, single-arm, multi-centre, dose-escalation trial evaluating single administration delivered subretinally. Preliminary evidence showed outer retinal structure and visual function improvements that persisted for up to four years of follow-up. Lineage’s CEO Brian Culley stated that the company’s observations are being reinforced by additional external and independent analysis from Roche and Genentech.

OpRegen is a retinal pigment epithelial (RPE) cell therapy and works by replacing the layer of damaged RPE cells. The data, presented at the 2023 Association for Research in Vision and Ophthalmology Annual Meeting, demonstrates that OpRegen provided “support to remaining retinal cells within atrophic areas by counteracting host RPE cell dysfunction and loss.” Lineage said that further assessment will identify the optimum disease stage for treatment intervention.

A Phase IIa study is currently enrolling patients.

“We are excited to collaborate with Genentech and Roche on the ongoing Phase IIa study of OpRegen, which is currently enrolling patients and open at multiple sites in the US, with more sites expected to come online this year,” said Culley.  

AMD is a disease that affects around one in every 200 people by the age of 60. Dry AMD, the type indicated in OpRegen’s development, has seen fewer trials despite it accounting for the majority of AMD cases. In February, the US Food and Drug Administration approved pegcetacoplan (Syfovre) as the first treatment for dry AMD.

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