Industry News
Alcon Acquires Majority Stake in Aurion Biotech to Advance Cell Therapy for Eye Diseases
Alcon has acquired a majority interest in Aurion Biotech, a clinical-stage company pioneering advanced cell therapies to treat eye diseases. The move underscores Alcon’s commitment to developing innovative treatments for conditions such as corneal endothelial disease, which affects millions worldwide.
Under the agreement, Aurion Biotech will continue to operate as a separate entity while benefiting from Alcon’s extensive R&D, regulatory, medical ophthalmic, and commercial expertise. This partnership aims to accelerate the clinical development of Aurion’s lead asset, AURN001, a promising allogeneic cell therapy designed to address corneal edema secondary to corneal endothelial disease. Aurion is set to initiate Phase 3 trials in the second half of 2025.
In conjunction with the transaction, Aurion Biotech’s Board of Directors has appointed Arnaud Lacoste, PhD, as Chief Executive Officer, effective immediately. Dr. Lacoste previously served as Aurion’s Chief Scientific Officer and played a key role in advancing its clinical and regulatory milestones.
“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.”
Aurion Biotech’s lead candidate, AURN001, has received both Breakthrough Therapy Designation and Regenerative Medicine Advanced Therapy Designation from the U.S. Food and Drug Administration (FDA). AURN001 is a combination therapy comprising allogeneic human corneal endothelial cells (neltependocel) and a rho kinase inhibitor (Y-27632). Although still investigational, the therapy represents a significant step toward addressing the chronic global shortage of corneal tissue. Through manufacturing innovations, a single donor’s cells can be expanded to produce up to 1,000 doses.
Aurion has already completed enrollment and dosing in its Phase 1/2 CLARA trial, a prospective, multi-centre, randomized study involving 97 patients across the U.S. and Canada. The trial’s findings have laid the groundwork for the upcoming Phase 3 development.
Further validating its innovative approach, Aurion launched its first commercial product, Vyznova™, in Japan in September 2024 for the treatment of bullous keratopathy. This condition, which affects corneal endothelial cells, leads to painful fluid accumulation and vision impairment. The success of Vyznova™ in Japan signals the potential for broader global adoption of Aurion’s cell therapy solutions.
“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, because we know there is a chronic global shortage of corneal tissue. With our manufacturing innovations, we can 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.”
By integrating Aurion Biotech’s cutting-edge cell therapy into its portfolio, Alcon strengthens its position as a leader in ophthalmic innovation, reinforcing its commitment to addressing the critical need for new vision-restoring therapies worldwide.
