Anatomical, functional improvements seen with OpRegen in phase 1/2a study
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Interim results from a study investigating OpRegen suggest a single treatment may provide improvements in patients with dry age-related macular degeneration with geographic atrophy, according to a Lineage Cell Therapeutics press release.
OpRegen, an investigational cell therapy consisting of allogeneic retinal pigment epithelium (RPE) cells administered to the subretinal space, demonstrated positive findings in the phase 1/2a clinical study. In cohort 4, in which patients had better baseline vision and smaller geographic atrophy areas than previous cohorts, 67% of the treated eyes of 12 patients were at or above their baseline visual acuity at their most recent assessment, ranging from 9 months to 3 years after transplant. Seventy-five percent of the untreated eyes were below baseline visual acuity.
When comparing all treated eyes with untreated eyes in cohort 4, there was a difference of 10.8 letters.
Patients with previously reported structural improvements in the retina, slowed progression of geographic atrophy and decreased drusen density in treated eyes across the whole study continued to experience these improvements.
“While competing efforts are focused on reducing the growth rate of geographic atrophy, Lineage has reported several patients whose areas of atrophy have stabilized or reduced in size,” Brian M. Culley, CEO of Lineage, said in the release. “These observations, which are present across clinically meaningful periods, indicate a reversal of the degeneration of critical retinal tissue layers which support vision, consistent with the proposed mechanism of an RPE cell transplant.”
One patient in cohort 4 showed no growth in atrophy at 33 months after treatment, while another showed a 10% reduction at about 8 months after treatment.
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