Aurion Biotech Announces Positive Topline Data for Phase 1/2 Clinical Trial of AURN001, an Allogeneic Cell Therapy Product Candidate for the Treatment of Corneal Edema Secondary to Corneal Endothelial Dysfunction
Aurion Biotech, Inc. (Aurion Biotech) announced topline data from its Phase 1/2 clinical trial (CLARA) of AURN001, an allogeneic cell therapy product candidate for the treatment of corneal edema secondary to corneal endothelial dysfunction. For the primary endpoint, a dose-dependent response was observed in the three AURN001 arms, with a statistically significant improvement in the high-dose AURN001 arm (50% of responders, p=0.020), as compared to the Y-27632-only arm (14.3%). A key secondary endpoint, change in BCVA at six months, showed a statistically significant improvement for the high-dose AURN001 arm (p=0.002), as compared to the Y-27632-only arm (using the full analysis set population (LOCF, LS mean2)). Additionally, a dose response was observed in the three AURN001 arms. For the key secondary endpoint, change in CCT at six months, there was a statistically significant improvement for the high-dose AURN001 arm (p=0.012), as compared to the Y-27632-only arm (using the full analysis set population (LOCF, LS Mean)).