Phase 2a clinical study to investigate RG6501 for geographic atrophy
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Genentech has launched a phase 2a clinical study of RG6501 for the treatment of geographic atrophy secondary to age-related macular degeneration, according to a press release from Lineage Cell Therapeutics.
The multicenter, open-label, single-arm study will evaluate the safety and activity of RG6501 (OpRegen), a retinal pigment epithelial cell therapy, in approximately 30 and up to 60 patients with geographic atrophy. The two primary objectives of the study are the evaluation of the proportion of patients with subretinal surgical delivery of OpRegen to target regions under the retina and the evaluation of the safety of subretinal surgical delivery of OpRegen as measured by procedure-related adverse events at 3 months after surgery, the release said.
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A secondary objective is the evaluation of qualitative improvement in retinal structure within 3 months of surgery using OCT imaging.
“In our phase 1/2a clinical trial, RG6501 (OpRegen) demonstrated the potential to slow, stop or reverse the progression of GA,” Brian M. Culley, CEO of Lineage, said in the release. “These results can be maintained beyond 1 year following a one-time, approximately 30-minute outpatient procedure. We are excited that Roche and Genentech are advancing the OpRegen program in a larger clinical study and will seek not only to optimize and potentially improve its delivery, but also confirm safety and activity of OpRegen in this patient population.”
The therapy is being developed as part of an exclusive worldwide collaboration between Lineage and Genentech/Roche.
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