The U.S. FDA has granted both Breakthrough Therapy designation (BTD) and Regenerative Medicine Advanced Therapy (RMAT) designation for Aurion Biotech's allogeneic cell therapy candidate for the treatment of corneal edema secondary to corneal endothelial disease.
According to Aurion — a spinoff of Seattle eye care company CorneaGen — AURN001 is the first allogeneic cell therapy to receive both FDA designations for the treatment of the sight-threatening and debilitating condition. While the condition is currently treated through corneal transplants, donor supplies are limited. If left untreated, corneal endothelial cell loss can cause corneal edema (swelling) and loss of vision.
The dual designations, which serve to increase interactions with the agency with the goal of expediting drug development, were granted based on the unmet medical need among patients with corneal endothelial disease and the FDA’s review of clinical data from the AURN001 program.
This news comes on the heels of Aurion’s April announcement that it completed enrollment and dosing of its phase 1/2 CLARA trial for AURN001 in the U.S. and Canada.
AURN001 is a combination cell therapy product comprised of neltependocel (allogeneic human corneal endothelial cells) and Y-27632 (an inhibitor of Rho-associated, coiled-coil containing protein kinase). The treatment is intended to be administered to the eye as a one-time, intracameral injection.
