SAN FRANCISCO — OpRegen, a human embryonic stem cell-derived retinal pigment epithelial cell therapy transplanted subretinally, appeared well-tolerated in patients with advanced dry age-related macular degeneration, according to data from an ongoing phase1/2a clinical study presented at the American Academy of Ophthalmology annual meeting.
“The idea is to transplant young, healthy cells to support/replace the failing cells in these patients,” Eyal Banin MD, PhD, director of the degenerative diseases of the retina and macula unit, department of ophthalmology, Hadassah Medical Center, Jerusalem, Israel, said during the presentation.
Banin reported interim accumulated safety, efficacy and imaging data from 15 patients participating in ongoing phase 1/2a clinical study who were administered OpRegen in suspension (50-200k cells) subretinally via pars plana vitrectomy or via Orbit-SDS, the suprachoroidal route. The researchers monitored systemic and ocular safety and assessed retinal function/structure using best corrected visual acuity (BCVA) and imaging.
The results showed that OpRegen was well tolerated and resulted in no unexpected adverse events.
Banin and colleagues observed imaging changes with OpRegen, which persisted for more than 3 years, the last time point examined. Specifically, these were subretinal pigmentation, a reduction in drusen density, irregular reflectance above areas of atrophy and changes in the ellipsoid zone on OCT imaging. Banin also reported rapid healing of the injection site following transplantation.
“There are some structural changes that need further follow-up,” Banin concluded. – by Savannah Demko
Reference: Banin E, et al. Phase 1/2a study of subretinally transplanted human embryonic stem cell-derived RPE cells in advanced dry-form AMD patients. Presented at: American Academy of Ophthalmology annual meeting; Oct. 11-15, 2019; San Francisco.
Disclosure: Banin reports patents from and consulting for Lineage Cell Therapeutics (Cell Cure Neurosciences).