First Canadian Patient Dosed in Aurion’s Cell Therapy Trial for Corneal Edema

Aurion Biotech has dosed the first Canadian participant in its phase 1/2 clinical trial, known as ABA-1, CLARA. The trial investigates the efficacy and safety of AURN001, a novel cell therapy aimed at treating corneal edema resulting from corneal endothelial dysfunction.

Introducing AURN001: A Novel Cell Therapy Approach

AURN001 is a pioneering combination cell therapy product that includes neltependocel (allogeneic human corneal endothelial cells) and Y-27632, a Rho-associated, coiled-coil containing protein kinase (ROCK) inhibitor. This therapy is designed for a one-time, intracameral injection directly into the eye.

The ABA-1, CLARA Trial: A Comprehensive Study

The ABA-1, CLARA trial is a forward-looking, multicenter, randomized, double-masked, parallel-arm study. It aims to explore cell dose-ranging effects in subjects suffering from corneal edema due to corneal endothelial dysfunction, planning to enroll around 100 participants across locations in the United States and Canada.

This clinical trial's core objective is to evaluate the safety, tolerability, and effectiveness of AURN001 in treating the targeted corneal condition. A crucial measure of success will be the percentage of subjects experiencing a three-line improvement in vision six months post-treatment.

Leadership and Vision for the Future

Michael Goldstein, MD, MBA, President and Chief Medical Officer of Aurion Biotech, expressed his enthusiasm about this progress, stating, “We are very pleased to have begun dosing subjects in this trial in Canada.” He emphasized the significance of conducting the CLARA trial across both the United States and Canada as a vital step forward in their clinical development program. Goldstein is optimistic about the potential of their cell therapy to transform the treatment landscape for patients with corneal conditions globally.

Corneal Edema Related to Corneal Endothelial Dysfunction

Corneal edema, resulting from corneal endothelial dysfunction, is a condition marked by the swelling of the cornea, the clear front surface of the eye, which leads to visual disturbances and discomfort. The corneal endothelium is a thin layer of cells on the inner surface of the cornea responsible for maintaining the cornea's clarity by pumping excess fluid out of the tissue. When these cells are damaged or deteriorate due to disease, aging, or injury, they lose their efficiency in regulating corneal hydration, leading to corneal edema. This dysfunction can cause blurred vision, light sensitivity, pain, and in severe cases, significant vision impairment.