Aurion Biotech, Inc. announced the completion of patient enrollment in the US ASTRA phase 3 pivotal study of AURN001, a single-administration investigational regenerative cell therapy for corneal edema secondary to corneal endothelial dysfunction. 

According to a company press release, AURN001 is a potential first-in-class investigational combination therapy for corneal endothelial disease, including Fuchs dystrophy. Consisting of unmodified human corneal endothelial cells (neltependocel) and a rho-kinase inhibitor (Y-27632), AURN001 is designed to regenerate corneal clarity and vision through an intracameral injection.

Patients were enrolled at 12 sites across the US. The primary endpoint is the percentage of participants who achieve at least a 15-letter improvement (3-line gain) from baseline in best-corrected visual acuity (BCVA) at month 6. Secondary endpoints are changes from baseline in central corneal thickness and BCVA at month 6.