Lineage Cell Therapeutics announced positive interim results from the ongoing 24-patient Phase 1/2a clinical study of Lineage’s lead product candidate, OpRegen, an investigational cell therapy consisting of allogeneic retinal pigment epithelium (RPE) cells administered to the subretinal space for the treatment of dry AMD with geographic atrophy (GA). At AAO, new data were presented on 20 patients, including 8 patients treated in cohort 4, which feature better baseline vision and smaller areas of GA. All 8 of these patients were treated with a new "thaw-and-inject" formulation of OpRegen, and 4 were treated using the Gyroscope Orbit Subretinal Delivery System (Gyroscope SDS).

Data showed improvements in visual acuity in 6 of 7 cohort 4 patients, with treated vs fellow-eye comparisons reaching statistical significance at 9 and 12 months following OpRegen administration. These improvements were maintained for up to 24 months in some patients. A trend toward slower GA growth was observed in the first 6 cohort 4 patients, and this was maintained for as long as 24 months in patients with 24-month data available.

Previously reported structural improvements in the retina and decreases in drusen density have continued with evidence of durable engraftment of OpRegen cells in treated patients, some more than 4 years following administration, with no immunosuppression utilized beyond the perioperative period. Overall, OpRegen appears to be well tolerated in all patients treated to date.

“These new data increasingly suggest to us that treatment with OpRegen can provide clinically meaningful outcomes in dry AMD patients with GA, particularly for those with earlier-stage disease," said Brian M. Culley, Lineage CEO, in a news release.