Aurion Biotech Doses First Patients in ASTRA Phase 3 Study, Evaluating AURN001 in Patients with Corneal Edema Secondary to Corneal Endothelial Dysfunction

U.S. pivotal trial to assess efficacy and safety of AURN001 compared to placebo

Potential first-in-class cell therapy to regenerate corneal clarity and restore vision with a single procedure

Excerpt from the Press Release:

SEATTLE & CAMBRIDGE, Mass. & TOKYO–(BUSINESS WIRE)–Aurion Biotech, Inc. (“Aurion Biotech”), a commercial-stage regenerative cell therapy company dedicated to restoring vision and working toward a future where blindness is eliminated, today announced that the first patients have been dosed in the U.S. ASTRA Phase 3 pivotal study of AURN001, a single-administration regenerative cell therapy for corneal edema secondary to corneal endothelial dysfunction. AURN001 has the potential to be the first cell therapy approved in the U.S. to treat this condition.

“Dosing the first ASTRA study participants marks an important milestone for patients, physicians, and Aurion as we work together to advance new solutions for vision loss from corneal endothelial disease,” said Edward J. Holland, MD, Chief Medical Officer, Aurion Biotech. “While modern endothelial keratoplasty procedures have transformed the treatment of the disease, there still is a need to reduce complications and improve our patient’s experience. AURN001 represents the potential next evolution by moving from donor tissue-based graft surgery toward a cultured cell therapy designed to restore corneal clarity and expand access to care for patients worldwide.”

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