Aurion Biotech has introduced AURN001, a novel treatment developed for addressing corneal oedema resulting from corneal endothelial disease.
The completion of enrolment and dosing in the Phase 1/2 CLARA trial across the United States and Canada has been achieved.
The CLARA trial is a prospective, multi-centre, randomised, double-masked study aimed at evaluating varying doses of neltependocel in combination with Y-27632. A total of ninety-seven subjects have been randomised at sites in the US and Canada.
The trial's primary objectives include assessing the safety, tolerability, and effectiveness of AURN001 in managing corneal oedema secondary to corneal endothelial dysfunction.
Corneal oedema secondary to endothelial dysfunction is a significant condition that threatens vision and impacts millions globally.
The loss or degradation of corneal endothelial cells, which do not regenerate, can lead to swelling and vision loss if untreated. While corneal transplants like PKP, DMEK, and DSAEK are effective, they are hindered by limitations such as a shortage of donor organs.
The U.S. Food and Drug Administration (FDA) has awarded breakthrough therapy designation (BTD) and regenerative medicine advanced therapy (RMAT) designation to AURN001, a cell therapy candidate developed for treating corneal oedema resulting from corneal endothelial disease.
