CLARA Phase 1/2 Trial explores new approaches to treating corneal edema

Aurion Biotech Inc. has released topline data from its Phase 1/2 CLARA clinical trial (NCT06041256) evaluating AURN001, an allogeneic cell therapy product candidate for the treatment of corneal edema secondary to corneal endothelial dysfunction.

In an interview with Ophthalmology Times, Zaina Al-Mohtaseb MD, a cataract, refractive, & cornea surgeon with Whitsett Vision Group, director of Research and clinical associate professor, Baylor College of Medicine, discusses the topline data. The therapy is designed to be administered as a one-time procedure into the anterior chamber of the eye.

Al-Mohtaseb pointed out that the CLARA Phase 1/2 clinical trial explored the safety and tolerability of corneal endothelial cell injection therapy combined with a rho kinase inhibitor for treating corneal edema. This randomized, multi-center, double-masked trial included five arms: 3 with varying doses of corneal endothelial cells and rho kinase inhibitor, 1 with only corneal endothelial cells, and 1 with only the inhibitor. The trial achieved a statistically significant improvement in visual acuity, specifically a 3-line gain (15 letters) on a vision chart at 6 months, alongside reductions in central corneal thickness.

The standout finding was the superior efficacy of high-dose combination therapy compared to the inhibitor alone. This is noteworthy as current treatments, like Descemet membrane endothelial keratoplasty (DMEK), involve challenging post-operative care, such as strict positioning, and carry risks like a 10% need for additional procedures (e.g., rebubbling). The new therapy significantly reduces patient burden, requiring minimal post-operative positioning and offering a simpler recovery.

Challenges included ensuring procedural consistency across surgeons, which was addressed through detailed training and standardized techniques. The streamlined procedure is anticipated to require minimal practice for proficiency, unlike the steep learning curve of DMEK.

This therapy could revolutionize treatment by using one donor cornea to treat up to 200 patients, significantly addressing global corneal tissue shortages. Its simplicity may allow general ophthalmologists, not just cornea specialists, to perform it, expanding access. Phase 3 trials and FDA regulatory processes are the next steps to bring this groundbreaking treatment to patients.