The FDA granted Aurion Biotech both Breakthrough Therapy designation (BTD) and Regenerative Medicine Advanced Therapy (RMAT) Designation for AURN001, the company’s allogeneic cell therapy candidate for the treatment of corneal edema secondary to corneal endothelial disease.

The dual designations granted to Aurion Biotech are based on BTD and RMAT criteria, the unmet medical need among patients with corneal endothelial disease, and the FDA’s review of clinical data from the AURN001 program, which includes multiple clinical trials with subjects having completed at least 12 months of follow-up, the company said in a press release.

This news comes on the heels of Aurion’s announcement that it completed enrollment and dosing of its Phase 1/2 CLARA trial in the Unites States and Canada. The CLARA clinical trial is a prospective, multi-center, randomized, double-masked, parallel-arm cell dose-ranging study 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.

The CLARA 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 the percentage of subjects who gain three lines of vision at 6 months.