Aurion Biotech, Inc. announced in a press release the first patients have been dosed in the US ASTRA phase 3 pivotal study of AURN001, a single-administration regenerative cell therapy for corneal edema secondary to corneal endothelial dysfunction. 

The first-in-class investigational combination therapy consists 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 that has the potential to reduce treatment-related complications and support a fast postoperative recovery, the company said in the press release.

According to Aurion Biotech, patients will be enrolled at 12 sites across the United States and randomized to AURN001 + Y-27632. The primary endpoint is the percentage of participants who achieve 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 non-contact central corneal thickness at Month 6 and change from baseline in BCVA at Month 6.