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Aurion Biotech Announces the Treatment Trial for IOTA Cell Therapy

Aurion Biotech, whose mission is to cure blindness by developing a differentiated platform of advanced therapies to treat ocular diseases, has released preliminary results from its IOTA trial. It took place at the Clinica Quesada in San Salvador, El Salvador, in November 2020 and May of this year. Professor Shigeru Kinoshita and colleagues at the Kyoto Prefecture University of Medicine devised a transformative cell treatment approach used on 50 patients with corneal endothelial dysfunction in the IOTA trial (KPUM).

Drs. Gabriel and Rodrigo Quesada, as well as U.S. surgeons Drs. Edward Holland, Elizabeth Yeu, John Berdahl, Matt Giegengack, John Vukich, and Kevin Waltz participated as investigators in the IOTA trial, the first corneal endothelial cell therapy procedure performed outside of Japan. The IOTA study was designed to demonstrate the feasibility of prior investigations of Professor Kinoshita’s and his KPUM colleagues’ cell treatment method.

Dr. Holland, chief medical advisor and medical advisory board chair at Aurion Biotech, said, “This is a landmark moment for the treatment of corneal endothelial disease. We achieved what we set out to accomplish: in IOTA-Part 1, we were able to treat 16 patients from a single donor. In IOTA-Part 2, we treated 34 patients from a single donor. Equally important: we confirmed that this procedure is accessible for surgeons and minimally invasive for patients.”

According to protocol recommendations, patients in the IOTA experiment will be monitored for safety and efficacy of treatment over a year, according to protocol recommendations, and beyond the trial’s conclusion. Aurion Biotech plans to publish crucial discoveries in the future to help advance medical and scientific knowledge about corneal endothelial cell treatment. Corneal edoema is a serious, vision-threatening, and debilitating condition that affects millions of people worldwide. Endothelial cells in the cornea do not renew when they die or degenerate. Corneal endothelial cell loss can eventually result in corneal edoema and vision loss.

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