Aurion Biotech begins phase 1/2 US clinical trial of cell therapy for corneal edema
Aurion Biotech announced that the first participant has been dosed in its phase 1/2 trial of AURN001, an investigational cell therapy for treatment of corneal edema secondary to corneal endothelial dysfunction.
According to a company press release, AURN001 is a combination of neltependocel — allogenic human corneal endothelial cells — and Y-27632, a Rho kinase inhibitor.
“There are very few moments of true game-changing innovation in any lifetime, so I feel privileged to be a part of the development of corneal endothelial cell therapy,” Edward J. Holland, MD, director of cornea services at Cincinnati Eye Institute, told Healio. “This is a tremendous breakthrough for surgeons and patients throughout the world.”
The retrospective, multicenter, randomized study of approximately 100 participants will examine three different doses of neltependocel with Y-27632, with the primary outcome of percentage of participants who gain three lines of vision at 6 months. The treatment will be administered as a one-time intracameral injection.
“On the heels of our recent approval in Japan, we are very pleased to have begun dosing subjects in this trial in the United States,” Michael Goldstein, MD, MBA, Aurion’s president and chief medical officer, said the release. “The start of this trial is another important milestone in our goal of bringing this corneal endothelial cell therapy to millions of patients in need throughout the world.”
Editor's note: This article was updated Oct. 24, 2023, to include additional comments.
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