Aurion Biotech Completes Phase 1/2 Trial Enrollment

Aurion Biotech, a company dedicated to restoring vision through innovative regenerative therapies, has successfully completed dosing for all participants in its Phase 1/2 clinical trial, known as CLARA. This trial investigates AURN001, an allogeneic cell therapy developed to address corneal edema caused by corneal endothelial dysfunction.

The company's President and Chief Medical Officer, Michael Goldstein, expressed satisfaction with the swift completion of enrollment and dosing within a six-month period. This rapid progress underscores the significant interest from both medical professionals and patients in the potential of this allogeneic cell therapy to treat a disease that threatens vision.

AURN001 is a unique cell therapy product that combines neltependocel, which consists of allogeneic human corneal endothelial cells, with Y-27632, an inhibitor of a specific protein kinase. It is designed to be administered as a single intracameral injection into the eye. The CLARA trial is a multi-center, randomized, double-masked study that aims to evaluate the safety, tolerability, and effectiveness of AURN001 at three different dosages. A total of 97 subjects have been enrolled across sites in the U.S. and Canada.

Corneal endothelial dysfunction is a serious condition that affects millions globally, leading to corneal edema and potential vision loss when the endothelial cells are damaged or die and fail to regenerate. Traditional treatments, such as corneal transplants, have limitations, including a shortage of donor corneas and the requirement for patients to lie flat post-operatively for several days.

Aurion Biotech is a clinical-stage biotech firm that has received accolades, including the esteemed Prix Galien award for the best start-up in the biotech sector. The company's first candidate therapy has already gained regulatory approval in Japan for corneal edema treatment. Aurion Biotech is privately funded by a consortium of investors, including Deerfield, Alcon, and others, and is committed to advancing its clinical trials in North America.