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Biosynthetic RPE monolayer for advanced dry AMD feasible, well-tolerated

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Amir Kashani

CHICAGO — It is feasible and safe to surgically implant an investigational human embryonic stem cell derived RPE monolayer on an ultrathin synthetic substrate to treat severe vision loss from geographic atrophy in patients with advanced dry age-related macular degeneration, according to a speaker here.

“Targeted delivery of implants to the subretinal space is very feasible in an outpatient basis, and intraoperative OCT was particularly useful but not absolutely necessary for identifying pathology and implant placement,” Amir H. Kashani, MD, PhD, said at the American Society of Retina Specialists meeting.

The phase 1/2a study enrolled 16 subjects with advanced dry AMD with geographic atrophy involving the fovea. Patients received surgical intervention on the eye with worse visual acuity and received a subretinal implantation of an investigational human embryonic stem cell derived RPE monolayer on an ultrathin synthetic substrate, Kashani said.

The RPE patch is designed to replace the lost RPE within the area of atrophy in AMD patients, he said.

Surgeons completed the procedure with or without intraoperative OCT guidance. The mean geographic atrophy area in the cohort reduced from 16.7 mm² at baseline to 5.36 mm² after RPE patch implantation. Four patients experienced greater than 90% geographic atrophy coverage.

“The implant in general covers a large fraction, if not the entirety, of the geographic atrophy,” Kashani said. – by Robert Linnehan

Reference: Kashani AH. Surgical Implantation of a Biosynthetic RPE Monolayer for Advanced Dry Age-Related Macular Degeneration (AMD): Experience From a Phase 1/2A Study. Presented at: American Society of Retina Specialists meeting; July 27-30, 2019; Chicago.

Disclosure: Kashani reports he is an investigator, speaker, and has other disclosures with Carl Zeiss Meditec. He reports he is an investigator with Regenerative Patch Technologies and a consultant with Visibly.