Alcon Acquires Majority Interest in Aurion Biotech

Alcon announced it has acquired a majority interest in Aurion Biotech, a clinical-stage company developing cell therapies to treat eye diseases.

Financial terms of the deal were not disclosed. 

According to Alcon, Aurion will operate as a separate company with support from Alcon to advance its clinical-stage allogeneic cell therapy asset, AURN001, into phase 3 for corneal edema secondary to corneal endothelial disease during the second half of 2025.

"Aurion will have access to the broader R&D, regulatory, medical ophthalmic and commercial capabilities of Alcon," Alcon stated in a news release. 

In conjunction with this transaction, the Aurion Board has appointed Arnaud Lacoste, PhD, formerly Chief Scientific Officer, to the role of CEO of Aurion effective immediately. Dr. Lacoste will replace Greg Kunst as CEO. The announcement comes after Alcon sued Aurion in November after Aurion announced its intent to go public. Alcon, which was Aurion's largest shareholder at the time with a 40.5% ownership, claimed it needed to first consent to an initial public offering before Aurion could pursue the IPO. Aurion challenged the claim in January and won a court decision in Delaware’s Court of Chancery.  Alcon vowed to appeal the decision at the time. 

Aurion received Breakthrough Therapy Designation and Regenerative Medicine Advanced Therapy Designation from the FDA for AURN001, which is a combination cell therapy product candidate comprised of allogeneic human corneal endothelial cells (neltependocel) and a rho kinase inhibitor (Y-27632). 

“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.”

“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," Dr. Lacoste said in a news release. "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." 

Aurion has completed enrollment and dosing of a prospective, multicenter, randomized, double-masked, parallel-arm dose-ranging, phase 1/2 clinical study of AURN001 (the CLARA trial). Ninety-seven subjects with corneal edema secondary to corneal endothelial dysfunction were randomized into five dosing arms at sites in the US and Canada. The results of this study support the advancement of AURN001 into phase 3 development.

In September 2024, Aurion announced the first global commercial launch of this technology, Vyznova (which includes neltependocel), in Japan for the treatment of bullous keratopathy of the cornea. 

The announcement comes just days after Alcon announced its plans ot acquire Lensar in a deal worth up to 430 million.