Alcon announced it has acquired a majority interest in Aurion Biotech, Inc., giving the global company access to a potentially groundbreaking corneal cell therapy currently under clinical investigation.
No intro needed on Alcon, so let’s talk about Aurion.
Formed in 2022, the Seattle, Washington-based, clinical-stage biotech company is focused on restoring vision loss (partial and total) among patients diagnosed with corneal endothelial disease (CED).
To fulfill this goal: The company has developed a proprietary, multi-step, and open cell therapy process that operates as a platform for advanced regenerative cell therapies.
- Its first clinical candidate: AURN001, an allogeneic cell therapy.
So what does this investment mean for Aurion, exactly?
Two major updates:
- The company will continue operating as a separate entity from Alcon
- Aurion now has access to Alcon’s broader research and development, regulatory, medical ophthalmic, and commercial capabilities
On the executive level, the company is also seeing a major change: Alcon has removed Aurion founder Greg Kunst as CEO and named former Chief Scientific Officer Arnaud Lacoste, PhD, as Aurion’s new leader—effective immediately.
That’s a pretty major change … what led us to this point?
Lots of legal developments, to say the least.
While Alcon Research was one of the original inventors (owning 36% in shares) of Aurion back in 2022 (when Aurion launched), the two companies have faced down in court over Aurion’s desire to turn public.
Most recently: A judge ruled in favor of Aurion in January 2025, determining that Aurion did not need Alcon’s approval to move forward with debuting on the public market.
- In response, Alcon had said it would appeal the decision (and see here for reports of what also happened after).
Interesting. Now to this majority stake: Any monetary details?
No, the company did not disclose any value in its announcement.
Alrighty then. Let’s circle back to Aurion’s cell therapy.
First, a rundown on its process: The platform is designed to culture and regenerate healthy cells from a single donor cornea in one minimally-invasive procedure, after which the regenerated cells are then manufactured to produce a therapeutic treatment for +1,000 recipient eyes.
- To note: The procedure is intended for rapid performance, with the patient recovery period estimated to be around 2 to 3 hours.
And this investigational candidate?
AURN001 is a combination cell therapy intended to be administered as a one-time intracameral injection into the anterior chamber of the eye for the treatment of corneal edema secondary to CED.
Its “combination” component includes:
- Neltependocel (allogeneic human corneal endothelial cells)
- Y-27632 (an inhibitor of Rho-associated, coiled-coil-containing protein kinase [ROCK])
Where is it in the clinical development process?
Already granted Breakthrough Therapy Designation (BTD) and Regenerative Medicine Advanced Therapy (RMAT) by the FDA, AURN001 is currently undergoing a phase 1/2 ABA-1 (CLARA) clinical study.
About the study: AURN001 is being evaluated in three cell doses (low, medium, and high) versus each of its individual components (neltependocel and Y-2763) randomized among patients with corneal edema secondary to CED.
- For more details on the setup and design of this trial (NCT06041256), see here.
Any data so far?
Aurion released topline findings in January 2025.
The crux of that data: The study met its primary endpoint, with the company reporting a dose-dependent response in the three AURN001 arms and statistically significant improvements in the high-dose AURN001 arm at 6 months.
In announcing the findings, Chief Medical Officer Michael Goldstein, MD, shared the company's intent to bring the high dose of AURN001 forward into proposed phase 3 pivotal trials.
So that’s the plan moving forward?
Indeed. With additional findings from the CLARA trial to be released in the coming months, the company plans to use its data to initiate phase 3 trials in the U.S. later in 2025.
And to support these developments, new CEO Dr. Lacoste stated that Aurion will leverage Alcon’s global resources and commercial expertise.