COEUR D’ALENE, Idaho — In patients with dry age-related macular degeneration, the implantation of human embryonic stem cell-derived retinal pigment epithelial cells was mostly well tolerated, according to a poster presented at the Women in Ophthalmology Summer Symposium.
Ghesal Razag and colleagues sought to evaluate the safety and tolerability of OpRegen (Lineage Cell Therapeutics) in a dose-escalating phase 1/2a clinical trial in patients with advanced dry AMD accompanied by geographic atrophy.
The researchers reported safety data from the first 15 patients with at least 3 years of follow-up after subretinal transplantation of 50,000 to 200,000 cells across four cohorts of patients.
A total of 246 adverse events were reported, with all subjects reporting at least one; 88.6% of the adverse events were classified as mild. Of the more frequently reported ocular adverse events, conjunctival hemorrhage after surgery was reported in eight subjects, subretinal pigmentation developed in eight subjects, and new or worsening epiretinal membrane developed in 13 subjects.
Regarding serious ocular adverse events, in one case the epiretinal membrane required surgical peel; in another, retinal detachment was reported 2 weeks postoperatively, the cause of which was unknown.
“Overall, OpRegen appears well tolerated with preliminary evidence of improved structural changes and potential improvement in visual acuity following treatment observed in some patients,” the authors wrote. – by Earl Holland Jr.
Razag G, et al. PI/IIa study of subretinally transplanted human embryonic stem cell-derived RPE cells (OpRegen) in advanced dry-form AMD patients. Presented at: Women in Ophthalmology Summer Symposium; Aug. 22-25, 2019; Coeur d’Alene, Idaho.
Disclosures: The study was supported by Lineage Cell Therapeutics and Cell Cure Neurosciences. Razag reports she is an employee with Lineage Cell Therapeutics. Please see the study for all other authors’ relevant financial disclosures.