Canadian Patient Receives First Dose in Aurion Biotech's Phase 1/2 Study

Aurion Biotech, a company dedicated to restoring vision through innovative regenerative therapies, has reached a significant milestone in its clinical trials. The first Canadian participant has been dosed in the Phase 1/2 study (CLARA) for AURN001, a novel cell therapy addressing corneal edema caused by dysfunctional corneal endothelium.

Michael Goldstein, Aurion Biotech's President and Chief Medical Officer, expressed enthusiasm about the trial's expansion to Canada, highlighting the importance of conducting the study in both the United States and Canada. He believes that their cell therapy could transform corneal treatment globally.

AURN001 is a unique cell therapy product, combining neltependocel, which consists of allogeneic human corneal endothelial cells, and Y-27632, an inhibitor of a specific protein kinase. The therapy is administered via a single intracameral injection into the eye. The clinical trial is a multi-center, randomized, double-masked study that will assess three different doses of the therapy. Approximately 100 subjects will participate in the trial, which is set to take place at sites in both the U.S. and Canada.

The primary goal of the study is to evaluate the safety, tolerability, and effectiveness of AURN001. The main outcome measure will be the proportion of subjects who experience a three-line improvement in vision after six months.

Corneal endothelial dysfunction, which leads to corneal edema and potential vision loss, is a serious condition affecting millions worldwide. The corneal endothelial cells do not regenerate once they are lost, and without treatment, vision can be permanently impaired. Corneal transplants are currently an effective solution but are limited by the availability of donor corneas, with a significant shortage existing globally.

Aurion Biotech, with locations in Seattle, Cambridge, and Tokyo, is a clinical-stage biotech firm focused on developing regenerative therapies for vision restoration. The company has received the esteemed Prix Galien award for the best biotech start-up and has regulatory approval in Japan for its corneal care cell therapy. Aurion Biotech's clinical trials are now underway in the U.S. and Canada, supported by prominent investors in the field.