Early-phase study shows potential for RPE implant for advanced geographic atrophy

A study found that a scaffold-based human embryonic stem cell-derived retinal pigmented epithelium (RPE) implant was well tolerated in patients with advanced geographic atrophy (GA) at a median of 3 years.

The single-arm, open-label, phase 1/2a study included 16 patients aged 69 to 85 years who were legally blind in the treated eye due to GA involving the fovea.

Fifteen patients successfully underwent RPE implantation to the eye that was more significantly affected by the disease, while the eye that did not receive the implant served as a control.

After a median follow-up of 3 years, the implant had not migrated in any patients. There were no unanticipated, severe, or implant-related adverse events recorded, according to the authors. The most common anticipated event was severe retinal hemorrhage, which was eliminated in a second cohort of participants due to improved intraoperative hemostasis.

During follow-up, best-corrected visual acuity improved in the implanted eye by more than 5 letters.

The study is limited by its small patient population.

“The safety profile, along with the early indication of efficacy, warrants further clinical evaluation of this novel approach for the treatment of GA,” the authors concluded.

Reference

Humayun MS, Clegg DO, Dayan MS, et al. Long-term follow-up of a phase 1/2a clinical trial of a stem cell-derived bioengineered retinal pigment epithelium implant for geographic atrophy. Ophthalmology. 2023:S0161-6420(23)00935-1. doi:10.1016/j.ophtha.2023.12.028