Alcon Acquires Majority Stake in Aurion Biotech to Advance Corneal Cell Therapy
Alcon, a global leader in eye care, has announced the acquisition of a majority interest in Aurion Biotech, Inc., a clinical-stage company specializing in advanced cell therapies for eye diseases. This strategic move enhances Alcon’s ophthalmic pharmaceutical portfolio and supports the development of innovative treatments for corneal endothelial disease.
Aurion’s Continued Independence and Strategic Support from Alcon
Aurion Biotech will continue to operate as a separate entity while benefiting from Alcon’s extensive resources, including research and development, regulatory expertise, medical ophthalmic support, and commercial capabilities. This partnership aims to accelerate the clinical advancement of Aurion’s allogeneic cell therapy asset, AURN001, which is expected to enter Phase 3 clinical trials for corneal edema secondary to corneal endothelial disease in the second half of 2025.
As part of this transition, Aurion’s Board has appointed Arnaud Lacoste, PhD, formerly the company’s Chief Scientific Officer, as its new Chief Executive Officer, effective immediately.
Alcon’s Commitment to Innovation in Ophthalmology
“Alcon is dedicated to developing and delivering innovative treatments for global unmet needs in eye care, including vision-threatening corneal endothelial disease, which affects millions of people worldwide,” said David Endicott, CEO of Alcon. “Dr. Lacoste and the Aurion team have done tremendous work, and their technology is a natural fit as we continue to expand our ophthalmic pharmaceutical portfolio. We recognize the exciting potential of cell therapies in ophthalmology, particularly given the shortage of available corneal tissue globally, and look forward to assisting Aurion in this promising area of patient care.”
Advancing AURN001 Through Clinical Development
Aurion Biotech’s lead investigational therapy, AURN001, has received Breakthrough Therapy Designation and Regenerative Medicine Advanced Therapy (RMAT) Designation from the U.S. Food and Drug Administration (FDA). AURN001 is a novel combination cell therapy consisting of allogeneic human corneal endothelial cells (neltependocel) and a rho kinase inhibitor (Y-27632). This innovative therapy is designed to address corneal edema caused by corneal endothelial disease, a condition that currently has limited treatment options. AURN001 is still under investigation and has not been approved by the FDA.
“As the global leader in eye care, Alcon will help Aurion optimize the development of AURN001,” said Dr. Lacoste. “Since Aurion’s formation in 2022, we’ve achieved significant clinical, regulatory, and CMC milestones to bring this much-needed therapy to patients. Given the chronic global shortage of corneal tissue, our manufacturing innovations allow us to expand cells from a single donor to produce up to 1,000 doses. We look forward to leveraging Alcon’s global resources and commercial expertise as we initiate our U.S. Phase 3 trials later this year.”
Clinical Progress and Global Expansion
Aurion Biotech has completed enrollment and dosing for a prospective, multi-center, randomized, double-masked, parallel-arm dose-ranging Phase 1/2 clinical trial of AURN001, known as the CLARA trial. This study enrolled 97 patients with corneal edema secondary to corneal endothelial dysfunction across multiple sites in the U.S. and Canada. The results of the trial support the continued development of AURN001 as it moves into Phase 3.
Additionally, Aurion Biotech achieved a significant milestone with the first global commercial launch of its technology in September 2024. Under the brand name Vyznova™ (which includes neltependocel), the therapy was introduced in Japan for the treatment of bullous keratopathy of the cornea. This sight-threatening condition damages endothelial cells, leading to fluid accumulation and blister formation on the cornea, often causing severe pain.
