Alcon, the global leader in eye care dedicated to helping people see brilliantly, announced it has acquired a majority interest in Aurion Biotech, Inc., a clinical-stage company developing advanced cell therapies to treat eye diseases.
Aurion will operate as a separate company with full 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. 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.
“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 has received Breakthrough Therapy Designation and Regenerative Medicine Advanced Therapy Designation from the U.S. Food and Drug Administration (FDA) for AURN001, a novel cell therapy for the treatment of corneal edema secondary to corneal endothelial disease. AURN001 is a combination cell therapy product candidate comprised of allogeneic human corneal endothelial cells (neltependocel) and a rho kinase inhibitor (Y-27632). This investigational product has not been approved by the FDA.
Also Read: Loopback Analytics & Ballad Health Expand Specialty Rx
“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.”
Aurion has completed enrollment and dosing of a prospective, multi-center, 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 U.S. 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. Bullous keratopathy is a sight-threatening and debilitating condition affecting the endothelial cells of the cornea causing accumulation of fluid in the form of blisters on the cornea, which can cause severe pain.
Source: Businesswire