Seattle, Wash. — Aurion Biotech has completed enrollment in its U.S. Phase 3 ASTRA pivotal study evaluating AURN001, an investigational regenerative cell therapy for corneal edema caused by corneal endothelial dysfunction.
The company said the study enrolled patients at 12 U.S. sites and represents a key step toward a planned Biologics License Application submission in the United States.
AURN001 is designed as a single-administration treatment and combines unmodified human corneal endothelial cells, known as neltependocel, with the rho-kinase inhibitor Y-27632. The therapy is administered through an intracameral injection and is intended to restore corneal clarity and improve vision.
“Completing enrollment in ASTRA is a shared achievement. Dosing our final patient in this study reflects the work of our investigators and site teams who executed with conviction, the patients who trusted us with their vision, and the cross-functional teams here at Aurion who cleared every obstacle along the way,” said Eris P. Jordan, OD, Chief Development Officer of Aurion Biotech.
Jordan said patient input helped shape the study design, including trial feasibility and endpoints considered important to people living with corneal endothelial disease.
The Phase 3 study is evaluating the efficacy and safety of AURN001 compared with vehicle control. Its primary endpoint is the percentage of participants achieving an improvement of at least 15 letters, or three lines, from baseline in Best Corrected Visual Acuity at six months.
Secondary endpoints include changes from baseline in central corneal thickness and Best Corrected Visual Acuity at six months.
Aurion said AURN001 could provide an alternative to treatments that depend on donor corneal tissue and more complex surgical procedures. The therapy is being studied for corneal endothelial disease, including Fuchs dystrophy.
“Completing enrollment in our U.S. pivotal study marks a major milestone for Aurion and an important step toward our planned BLA submission,” said Arnaud Lacoste, Ph.D., MBA, Chief Executive Officer and Chief Scientific Officer of Aurion Biotech. “This achievement reflects the strength of the foundation established across our regulatory, quality, manufacturing, and clinical teams from the outset of the program.”
Aurion Biotech is a regenerative cell therapy company focused on treatments intended to restore vision.
