Aurion Biotech completes dosing in a major clinical trial testing a novel cell therapy for treating corneal endothelial dysfunction, offering potential new treatment avenues beyond traditional corneal transplants.
In a significant step forward for the treatment of corneal diseases, Aurion Biotech has recently completed dosing the last patient in its groundbreaking Phase 1 / 2 clinical trial, known as CLARA, testing a novel allogeneic cell therapy named AURN001. This innovative therapy aims to treat corneal edema caused by corneal endothelial dysfunction, a condition that affects millions globally and can lead to severe vision impairment.
Corneal endothelial dysfunction occurs when the endothelial cells on the inner layer of the cornea die or degrade and fail to regenerate, potentially causing corneal edema and significant visual loss. Current treatments largely depend on corneal transplants like PKP, DMEK, and DSAEK procedures, which, despite their efficacy, are limited by the availability of donor corneas and require complex post-operative care, including patients needing to remain immobile for extended periods.
Responding to the urgent need for more accessible treatments, AURN001 was developed by Aurion Biotech as a less invasive alternative. This therapy combines neltependocel, consisting of allogeneic human corneal endothelial cells, with Y-27632, a compound that inhibits Rho-associated, coiled-coil containing protein kinase (ROCK), promoting cell survival and adhesion. Unlike traditional corneal transplants, AURN001 is administered via a single intracameral injection, directly into the eye, simplifying the procedure and potentially reducing recovery times.
The CLARA trial enrolled 97 subjects across multiple sites in the US and Canada within a remarkably short span of six months. This rapid enrollment underscores the strong interest from both the medical community and patients and highlights the substantial demand for new solutions in this area of ophthalmology.
The primary goal of the trial is to evaluate the safety, tolerability, and efficacy of three different doses of neltependocel combined with Y-27632. A key outcome measure for AURN001 is the improvement in vision, quantified by the ability of treated patients to gain three lines of vision at the six-month mark.
The successful completion of enrollment and dosing in this pivotal trial marks a crucial phase in Aurion Biotech’s efforts to develop an effective alternative treatment option that could potentially benefit millions of patients worldwide. It reflects significant progress in the field of regenerative medicine and cell therapy applied to ophthalmology.
Aurion Biotech, recognised for its innovative work in the field including a prestigious Prix Galien award for best start-up, continues to push the frontier of what’s possible in eye care. The results from the CLARA trial will be highly anticipated as they could herald a new era of treatment for corneal endothelial dysfunction, moving away from dependency on donor tissues and towards a more sustainable, scalable therapeutic approach.
