Aurion Biotech Advances to Phase III Trials with Promising Allogeneic Cell Therapy for Corneal Oedema

Clinical Trial Success:
The CLARA Phase I/II clinical trial showed positive outcomes for AURN001, an allogeneic cell therapy combining human corneal endothelial cells (neltependocel) and a rho kinase inhibitor (Y-27632), in treating corneal oedema secondary to corneal endothelial dysfunction12.

Phase III Advancement:
Based on the trial's favorable safety profile and efficacy, particularly in the high-dose arm, Aurion Biotech plans to advance AURN001 to Phase III pivotal trials15.

Efficacy:
Fifty percent of responders in the high-dose AURN001 arm achieved more than 15 letters of improvement in best-corrected visual acuity (BCVA) at six months, compared to those treated with Y-27632 alone1.

Secondary Endpoints:
Key secondary endpoints demonstrated statistically significant improvements in BCVA and central corneal thickness in the high-dose AURN001 arm at six months1.

Clinical Trial Design:
The CLARA trial was a multicenter, randomized, double-masked, dose-ranging study conducted in the US and Canada, with 97 patients enrolled across five treatment arms2.

Potential Impact:
AURN001 aims to provide a minimally invasive alternative to corneal transplantation, addressing the global shortage of donor corneal tissue and offering hope for patients with sight-threatening conditions2.

Sources:

1. https://www.europeanpharmaceuticalreview.com/news/240632/early-allogeneic-cell-therapy-trial-results-offer-hope-for-sight-condition/

2. https://www.cgtlive.com/view/aurion-biotech-evaluating-combination-cell-therapy-product-aurn001-alternative-corneal-transplant-aba-1-clara-clinical-trial

5. https://c.firstwordpharma.com/firstwordgroup/assets/images/eyemagnifyingglass.jpg?sa=X&ved=2ahUKEwjav-qtrLaKAxV0lokEHTpoG-cQ_B16BAgFEAI