Aurion Biotech: Cell Therapy AURN001 Improves Vision in Patients with Corneal Endothelial Disease

1. AURN001 demonstrates improvement of visual acuity in patients with corneal endothelial dysfunction.
2. The CLARA trial demonstrates favorable safety profiles across all treatment arms.

The Latest

The CLARA Phase 1/2, prospective, multi-center, randomized, double-masked, parallel-arm dose-ranging clinical trial designed to assess the safety, tolerability and efficacy of AURN001 for the treatment of corneal edema secondary to corneal endothelial dysfunction. Ninety-seven subjects were randomized at US and Canadian sites to one of five treatment arms of the study which included three increasing doses of the regenerative medicine. The baseline best corrected visual acuity (BCVA) was 53.5 letters using the Early Treatment Diabetic Retinopathy Standard visual acuity. The primary endpoint was the proportion of responders with a >15-letter improvement from baseline in BCVA at six months. A dose-dependent response was observed in the all three dosages, with a statistically significant improvement in the high-dose AURN001 arm. Additionally, improvement in patient reported quality of life was assessed with the Visual Function Questionnaire (VFQ-25) with a greatest benefit seen in the high dose AURN001 arm. All doses were reported to be well tolerated with favorable safety profiles.

Physicians Perspective

Corneal endothelial dysfunction occurring secondary to corneal edema is a sight-threatening condition affecting millions of people throughout the world. When corneal endothelial cells die, they do not regenerate. As a result, corneal endothelial cell degradation can eventually lead to loss of vision. The current treatment option is a corneal transplant. However, this procedure is complex, invasive and time-consuming. Furthermore, there is only one health donor cornea available for every 70 diseased eyes. Therefore, there is a significant unmet need for patients with corneal endothelial dysfunction to receive alternative therapy that is minimally invasive and not limited by lack of donor cornea supply. AURN001 does not require surgery and is delivered through straightforward injection that can be performed by any ophthalmologist or cataract specialist. AURN001 replicates cells from one healthy cornea to treat up to 100 eyes, which dramatically increases the supply ratio for patients.

Molecular Targets

AURN001 is a combination cell therapy product comprised of allogeneic human corneal endothelial cells (neltependocel) and a rho kinase inhibitor (Y-27632). Neltependocel functions to modulate the immune system through targeting specific cytokines and immune cells that play a role in inflammation and immune response. When neltependocel binds to these targets, it reduces the production of pro-inflammatory cytokines and alters the activity or immune cells. The combination therapy works to restore corneal thickness as well as maintain immunological homeostasis of the eye.

Company History

Aurion Biotech is headquartered in Seattle, Washington and is focused on advanced therapies to treat diseases of the eye. The company most recently developed and launched the first commercially available corneal endothelial cell therapy in Japan.

Further Reading: https://aurionbiotech.com/aurion-biotech-announces-positive-data-for-phase_1-2_trial/

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