News
Article
Author(s):
The company announced it will share clinical data at Eyecelerator and the American Society of Cataract and Refractive Surgery 2024 Annual Meeting in Boston.
Aurion Biotech announced several presentations scheduled during the American Society of Cataract and Refractive Surgery 2024 Annual Meeting, being held April 5 to 8 in Boston, Massachusetts.
According to a news release, during Eyecelerator and ASCRS 2024, data will be presented from the company’s Escalón and IOTA studies, which treated subjects with its combination cell therapy product (biologic/drug) comprised of neltependocel (allogeneic human corneal endothelial cells [CECs]) and Y-27632 (an inhibitor of Rho-associated, coiled-coil containing protein kinase [ROCK]).1
“We are delighted to share additional insights into these clinical studies, in multiple sessions at the Eyecelerator and ASCRS 2024 meetings,” Michael Goldstein, MD, president and chief medical officer, Aurion Biotech, said in the news release. “We believe these presentations will be of significant interest to the ophthalmology community, as they highlight the exciting potential of our cell therapy to treat patients with corneal endothelial disease.”
The company noted the schedule of presentations includes:
According to the news release, the company recently opened a Phase 1 / 2 clinical trial (ABA-1 / CLARA), a prospective, multi-center, randomized, double-masked, parallel-arm cell dose-ranging study in subjects with corneal edema secondary to corneal endothelial dysfunction. The study will evaluate three different doses of neltependocelused in combination with Y-27632. Approximately 100 subjects will be randomized in sites in the U.S. and in Canada.
The ABA-1 / CLARA trial is designed to assess the safety, tolerability, and efficacy of AURN001 for the treatment of corneal edema secondary to corneal endothelial dysfunction. The primary endpoint is the percentage of subjects who gain 3 lines of vision at 6 months.1
The company noted in the news release its combination cell therapy recently received regulatory approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), for the treatment of bullous keratopathy, marking the first-ever regulatory approval in the world for an allogeneic cell therapy to treat corneal endothelial disease.1