- Leverages Alcon's global scale with Aurion's cell therapy expertise to accelerate U.S. Phase 3 development in fall of 2025
- Aurion's lead asset received Breakthrough Therapy Designation and Regenerative Medicine Advanced Therapy Designation from the U.S. Food and Drug Administration (FDA)
- Positions Alcon at the leading edge of biopharma applications in ophthalmology with the potential to advance the first-ever corneal cell therapy candidate
Regulatory News:
Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated to helping people see brilliantly, today announced it has acquired a majority interest in AurionBiotech, 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.
"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.
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About Alcon
Alcon helps people see brilliantly. As the global leader in eye care with a heritage spanning over 75 years, we offer the broadest portfolio of products to enhance sight and improve people's lives. Our Surgical and Vision Care products touch the lives of more than 260 million people in over 140 countries each year living with conditions like cataracts, glaucoma, retinal diseases and refractive errors. Our more than 25,000 associates are enhancing the quality of life through innovative products, partnerships with Eye Care Professionals and programs that advance access to quality eye care. Learn more at www.alcon.com.
About Aurion Biotech, Inc.
Aurion Biotech's mission is to restore vision to millions of patients with life-changing regenerative therapies. It received the prestigious Prix Galien award for best start-up in biotech in 2022. Aurion Biotech is advancing AURN001, an investigational single administration, allogeneic cell therapy to treat corneal edema secondary to corneal endothelial dysfunction. Aurion Biotech developed and has launched the first commercially available corneal endothelial cell therapy in Japan. To learn more, visit www.aurionbiotech.com.
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