Alcon Acquires Majority Interest in Aurion Biotech, Inc. to Advance Innovative Cell Therapy for Corneal Endothelial Disease

Rhea-AI Summary

Alcon (ALC) has acquired a majority stake in Aurion Biotech, a clinical-stage company developing advanced cell therapies for eye diseases. The key asset, AURN001, has received Breakthrough Therapy and Regenerative Medicine Advanced Therapy Designations from the FDA for treating corneal edema.

Aurion will operate independently with Alcon's support to advance AURN001 into Phase 3 trials in the second half of 2025. The therapy can produce up to 1,000 doses from a single donor, addressing the global shortage of corneal tissue. Aurion has completed a Phase 1/2 clinical study (CLARA trial) with 97 subjects across the US and Canada.

The company has already achieved its first global commercial launch with Vyznova™ in Japan for treating bullous keratopathy. Dr. Arnaud Lacoste, formerly Chief Scientific Officer, has been appointed as Aurion's CEO.

Positive

• FDA granted Breakthrough Therapy and Regenerative Medicine Advanced Therapy Designations for AURN001
• Technology can produce up to 1,000 doses from a single donor cornea
• Successfully completed Phase 1/2 trial with 97 subjects
• Already achieved commercial launch of Vyznova™ in Japan

Negative

• Phase 3 trials won't begin until second half of 2025
• AURN001 still requires FDA approval with no guaranteed success

Insights

Pharmaceutical Industry Analyst

Alcon's acquisition of a majority stake in Aurion Biotech represents a strategically significant expansion into advanced cell therapies for ophthalmology. This move goes beyond simply adding a new product candidate - it positions Alcon at the frontier of regenerative medicine in eye care with potentially transformative technology.

What makes this acquisition particularly compelling is the regulatory momentum behind Aurion's AURN001 therapy, having secured both Breakthrough Therapy and Regenerative Medicine Advanced Therapy designations from the FDA. These designations aren't merely ceremonial - they typically accelerate development timelines and signal the FDA's recognition of both significant unmet medical need and promising preliminary clinical data.

The fact that this technology has already achieved commercial launch in Japan (as Vyznova) provides real-world validation that derisks the development pathway in the US. This isn't merely a speculative early-stage asset but rather a clinically advanced therapy with proof-of-concept in a major regulated market.

From a manufacturing perspective, Aurion's ability to produce up to 1,000 doses from a single donor addresses the critical global shortage of corneal tissue while potentially creating favorable economics at scale. This acquisition aligns perfectly with Alcon's stated strategy of expanding its pharmaceutical portfolio while leveraging its global infrastructure to accelerate development of innovative therapies.

Ophthalmology Specialist

The clinical significance of this acquisition cannot be overstated from a patient care perspective. Corneal endothelial disease represents a major unmet need affecting millions globally, with traditional treatments to invasive corneal transplantation procedures that rely on scarce donor tissue.

AURN001's completion of the Phase 1/2 CLARA trial with 97 subjects across multiple centers provides a substantial clinical foundation for the upcoming Phase 3 program. The double-masked, randomized, dose-ranging design of the completed trial suggests methodological rigor that strengthens confidence in the results supporting advancement.

The technology itself represents a paradigm shift in corneal disease management. Rather than replacing the entire cornea, this cell therapy aims to restore the critical endothelial layer responsible for maintaining corneal clarity. For patients with bullous keratopathy - a condition causing painful blisters on the cornea - this could offer relief without the complications and recovery time associated with full transplantation.

The structure of keeping Aurion as a separate entity while providing access to Alcon's resources creates an ideal environment for continued innovation. Dr. Lacoste's transition from CSO to CEO maintains scientific leadership continuity while leveraging Alcon's commercial expertise - a thoughtful approach to preserving the innovation culture while accelerating development and eventual commercialization.

• 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

GENEVA--(BUSINESS WIRE)-- 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 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.

“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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Investor Relations

Daniel Cravens, Allen Trang

+ 41 589 112 110 (Geneva)

+ 1 817 615 2789 (Fort Worth)

investor.relations@alcon.com

Media Relations

Steven Smith

+ 41 589 112 111 (Geneva)

+ 1 817 551 8057 (Fort Worth)

globalmedia.relations@alcon.com

Source: Alcon Inc. Swiss

FAQ

What is the significance of Alcon's acquisition of Aurion Biotech for ALC stock?

The acquisition positions Alcon at the forefront of ophthalmic cell therapy, expanding their portfolio with AURN001, an FDA-designated breakthrough therapy that could address the global corneal tissue shortage.

When will Alcon (ALC) begin Phase 3 trials for AURN001?

Phase 3 trials for AURN001 are scheduled to begin in the second half of 2025.

How many doses can Aurion's cell therapy produce from a single donor for ALC?

The technology can produce up to 1,000 doses from a single donor cornea.

What regulatory designations has AURN001 received for Alcon (ALC)?

AURN001 has received both Breakthrough Therapy Designation and Regenerative Medicine Advanced Therapy Designation from the FDA.

Has Alcon's (ALC) new cell therapy been approved in any markets?

Yes, the technology has been commercially launched in Japan under the brand name Vyznova™ for treating bullous keratopathy.