Alcon Acquires Aurion Biotech to Advance Cell Therapy for Corneal Diseases

Introduction

In a significant move within the ophthalmology sector, Alcon, a global leader in eye care, has acquired a majority stake in Aurion Biotech, a clinical-stage company specializing in advanced cell therapies for eye diseases. This acquisition aims to accelerate the development of innovative treatments for corneal endothelial diseases, addressing a critical global need.

Aurion Biotech’s Innovative Cell Therapy: AURN001

Aurion Biotech’s flagship product, AURN001, is an allogeneic cell therapy designed to treat corneal edema secondary to corneal endothelial disease. This therapy involves the use of donor-derived corneal endothelial cells combined with a rho kinase inhibitor, Y-27632, to promote cell adhesion and proliferation. Notably, AURN001 has received both Breakthrough Therapy Designation and Regenerative Medicine Advanced Therapy Designation from the U.S. Food and Drug Administration (FDA), underscoring its potential to address unmet medical needs.

Strategic Fit and Operational Independence

Post-acquisition, Aurion Biotech will operate as an independent entity, benefiting from Alcon’s extensive resources in research and development, regulatory affairs, medical ophthalmology, and commercialization. This structure aims to preserve Aurion’s innovative culture while leveraging Alcon’s global infrastructure to expedite the development and potential commercialization of AURN001.

David Endicott, CEO of Alcon, expressed enthusiasm about the acquisition, stating, “Aurion’s 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.”

Leadership Transition

Concurrent with the acquisition, Aurion Biotech’s Board has appointed Dr. Arnaud Lacoste, formerly the Chief Scientific Officer, as the new CEO. Dr. Lacoste’s leadership is expected to drive the company’s mission to restore vision to millions through regenerative therapies. He commented, “With Alcon’s support, we are one giant step closer to delivering on our goal to eliminate a form of blindness that affects millions of patients worldwide.”

Advancements in Clinical Development

Aurion Biotech has completed enrollment and dosing in a Phase 1/2 clinical trial (the CLARA trial) involving 97 subjects with corneal edema secondary to corneal endothelial dysfunction across sites in the U.S. and Canada. The positive outcomes from this study support the advancement of AURN001 into Phase 3 development, anticipated to commence in the latter half of 2025.

Furthermore, Aurion achieved a significant milestone with the commercial launch of Vyznova™ in Japan in 2024, marking the first global introduction of its cell therapy for treating bullous keratopathy, a severe corneal condition.

Addressing the Global Shortage of Corneal Tissue

A critical advantage of Aurion’s technology is its ability to expand cells from a single donor cornea to produce up to 1,000 doses of AURN001. This scalability addresses the chronic global shortage of corneal tissue, offering a sustainable solution to a pervasive healthcare challenge. Dr. Lacoste highlighted, “With our manufacturing innovations, we can expand cells from a single donor to produce up to 1,000 doses.”

Conclusion

Alcon’s acquisition of a majority stake in Aurion Biotech represents a strategic advancement in the field of ophthalmology, particularly in addressing corneal endothelial diseases. By integrating Aurion’s pioneering cell therapy solutions with Alcon’s global capabilities, this collaboration holds the promise of transforming treatment paradigms for patients worldwide, offering hope to millions affected by vision-threatening conditions.