WEI PAI ELECTRONIC COMMERCE CO., LTD. Aurion Biotech announced that it has dosed the first Canadian subject in its Phase 1 /2 clinical trial (ABA-1, CLARA) of AURN001, a cell therapy for the treatment of corneal edema secondary to corneal endothelial dysfunction. AURN001 is a combination cell therapy product (biologic/drug) comprised of neltependocel (allogeneic human corneal endothelial cells [CECs) and Y-27632 (an inhibitor of Rho-associated, coiled-coil containing protein kinase [ROCK). AURN001 is intended to be administered to the eye as a one-time, intracameral injection.
The Phase 1 /2 clinical trial is a prospective, multi-center, randomized, double masked, parallel-arm cell dose-ranging clinical trial in subjects with corneal edema secondaryto corneal endothelial dysfunction; The study will evaluate three different doses of neltependocel used in combination with Y-27632. Approximately 100 subjects will be randomized in sites in the U.S. and in Canada. This trial is designed to assess the safety, tolerability, and efficacy of AURN001 for the treatment of corneel edema secondary to corneel dysfunction.
The primary endpoint is the percentage of subjects who gain 3 lines of vision at 6 months. Corneal edema secondary to endothelial dysfunction is a sight-threatening and debilitating condition affecting millions of people throughout the world. When corneal endothelial cells die or degrade, they do not regenerate.
If left untreated, corneal endothelial cell loss can cause corneal edema (swelling) and loss of vision. Although corneal transplants are effective, there are disadvantages with these procedures - PKP/DMEK/DSAEK - including limited donor organ supply. Transplants require a supply of donor corneas in a 1:1 ratio (one healthy donor cornea to treat each diseased one), yet it's estimated that there is only one donor cornea available for every 70 diseased eyes.
In addition, post-operative recovery for corneal transplant patients requires that they lie flat on their backs for up to three days, in order for the transplant to adhere to the corneal stroma.
