According to the company, the clinical trial will assess the safety, efficacy and tolerability of AURN001, a combination cell therapy product.
Aurion Biotech today announced that it has dosed the first subject in its Phase 1/2 US clinical trial (ABA-1, CLARA) of AURN001, a cell therapy for the treatment of corneal edema secondary to corneal endothelial dysfunction.1
Michael Goldstein, MD, MBA, President and Chief Medical Officer of Aurion Biotech, noted in a news release1 that on the heels of the company’s recent approval in Japan, it was pleased to start dosing subjects in this trial in the United States.
“The start of this trial is another important milestone in our goal of bringing this corneal endothelial cell therapy to millions of patients in need throughout the world,” Goldstein said. “We believe that cell therapy has the potential to revolutionize the treatment of corneal patients around the world.”
According to the company, AURN001 is a 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]). AURN001 is intended to be administered to the eye as a one-time, intracameral injection.1
According to the company, its Phase 1 / 2 clinical trial (ABA-1, CLARA) is a prospective, multi-center, randomized, double masked, parallel-arm cell dose-ranging clinical trial in subjects with corneal edema secondary to corneal endothelial dysfunction. The study will evaluate three different doses of neltependocel used in combination with Y-27632. Approximately 100 subjects will be randomized at US sites.1
This 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 percentage of subjects who gain 3 lines of vision at 6 months.1
1. Aurion Biotech Announces First Subject Dosed in U.S. Phase ½ Clinical Trial. Published October 24, 2023. Accessed October 24, 2023. https://headlinesoftoday.com/topic/press-release-aurion-biotech-announces-first-subject-dosed-in-u-s-phase-1-2-clinical-trial.html.