Aurion Biotech Initiates Phase 1/2 Clinical Trial with First Canadian Patient Treated

Aurion Biotech, a biotech firm with a vision to restore sight to millions through regenerative therapies, has commenced a Phase 1/2 clinical trial for AURN001, a novel cell therapy addressing corneal edema due to endothelial dysfunction. The first Canadian participant has been administered the treatment, marking a significant step in the company's clinical development. Michael Goldstein, Aurion's President and Chief Medical Officer, expressed enthusiasm for the trial's expansion to Canada, highlighting the potential global impact of their therapy.
AURN001 is a unique cell therapy product that includes neltependocel, which are allogeneic human corneal endothelial cells, and Y-27632, an inhibitor of a specific protein kinase. The treatment is designed for a single intracameral injection into the eye. The clinical trial, known as CLARA, is a multi-center, randomized, double-masked study that will assess three varying doses of the therapy in approximately 100 subjects across the U.S. and Canada.
The primary goal of the trial is to evaluate the safety, tolerability, and effectiveness of AURN001, with a focus on the improvement in vision measured by the gain of three lines at six months post-treatment. Corneal endothelial dysfunction, which leads to corneal edema and potential vision loss, is a serious condition affecting millions. Current treatments, such as corneal transplants, have limitations, including a shortage of donor corneas and the requirement for a lengthy post-operative recovery period.
Aurion Biotech, with locations in Seattle, Cambridge, and Tokyo, is a clinical-stage company that has received the esteemed Prix Galien award for its work in biotech. The company's first candidate, targeting corneal edema, has already received regulatory approval in Japan and is now under clinical evaluation in North America. Aurion Biotech is supported by prominent investors and is dedicated to providing innovative solutions for corneal care. 

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