Aurion Biotech Completes Enrollment in Corneal Edema Clinical Trial

Aurion Biotech has officially completed the dosing of all participants in its phase 1/2 clinical trial, known as CLARA, testing AURN001, an innovative allogeneic cell therapy aimed at treating corneal edema resulting from corneal endothelial dysfunction.

About AURN001 Therapy

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

Details of the CLARA Trial

The CLARA trial is a prospective, multicenter, randomized, double-masked, parallel-arm study that explores the efficacy of three varying doses of neltependocel combined with Y-27632. It has enrolled 97 subjects across various sites in the United States and Canada. The objective of the trial is to evaluate the safety, tolerability, and effectiveness of AURN001 in treating corneal edema due to corneal endothelial dysfunction.

A key measure of success for the trial is the percentage of subjects who achieve a three-line gain in vision at six months. The drug product used in the CLARA trial was supplied by Aurion’s contract development and manufacturing organization (CDMO) partner, Charles River Laboratories, from their facility in Memphis, Tennessee.

Executive Insights

Michael Goldstein, MD, MBA, President and Chief Medical Officer at Aurion Biotech, expressed his satisfaction with the trial's progress: “Aurion Biotech is delighted that both enrollment and dosing in our phase 1/2 trial are now complete, and that it happened more rapidly than we expected,” he stated in a press release. “We enrolled and dosed subjects in 6 months, which speaks to the deep interest among physicians and patients for our allogeneic cell therapy, as well as the potentially large, unmet need for our elegant, minimally invasive procedure to treat this sight-threatening disease.”

Corneal Edema due to Corneal Endothelial Dysfunction

Corneal edema resulting from corneal endothelial dysfunction is a medical condition where the cornea, the clear front layer of the eye, swells due to dysfunction of the endothelial cells. These cells line the inner surface of the cornea and are crucial for maintaining its clarity by pumping excess fluid out of the tissue. When these cells are damaged or their function is impaired, fluid begins to accumulate within the corneal layers, leading to swelling (edema). This can result in blurred vision, halos around lights, eye pain, and severe visual impairment. The condition can be caused by aging, genetic disorders, surgical damage, or diseases such as Fuchs' dystrophy.