Aurion Biotech completes enrollment in phase 1/2 corneal edema cell therapy trial
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Key takeaways:
- AURN001 is an allogeneic cell therapy being evaluated for corneal edema secondary to corneal endothelial dysfunction.
- The therapy is intended to be administered as a one-time intracameral injection.
Subject dosing is complete in a phase 1/2 clinical trial of an allogeneic cell therapy for the treatment of corneal edema secondary to corneal endothelial dysfunction, according to a press release.
AURN001 (Aurion Biotech) is a combination cell therapy made from neltependocel, or allogeneic human corneal endothelial cells, and Y-27632, an inhibitor of Rho-associated coiled-coil containing protein kinase. It is administered as a one-time intracameral injection.
Image: Adobe Stock
In the CLARA trial, three different doses of neltependocel used in combination with Y-27632 are being evaluated in 97 subjects. The primary endpoint of the trial, designed to assess the safety, tolerability and efficacy of AURN001, is the percentage of subjects who gain three lines of vision at 6 months.
“Aurion Biotech is delighted that both enrollment and dosing in our phase 1/2 trial are now complete, and that it happened more rapidly than we expected,” Michael Goldstein, MD, MBA, president and chief medical officer of Aurion Biotech, said in the release. “We enrolled and dosed subjects in 6 months, which speaks to the deep interest among physicians and patients for our allogeneic cell therapy, as well as the potentially large, unmet need for our elegant, minimally invasive procedure to treat this sight-threatening disease.”
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