IOTA study: One donor cornea may help treat ‘hundreds of patients’
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LAS VEGAS — Instead of using one donor cornea for one patient, endothelial cell therapy may allow tissue from one donor to be used by as many as 100 patients, according to a study.
Edward J. Holland, MD, presented findings from the IOTA trial during the Richard L. Lindstrom, MD, Medal Lecture at the American Society of Cataract and Refractive Surgery meeting. The IOTA trial included the first successful injectable corneal endothelial cell therapy (Aurion Biotech) procedures performed outside of Japan, where it was first developed by Shigeru Kinoshita, MD, PhD, and colleagues at Kyoto Prefecture University of Medicine.
The procedure would help treat more patients with fewer corneas and help scale corneal transplants to more parts of the world, particularly developing countries, Holland said.
“One cornea can supply endothelium for possibly hundreds of patients,” he said. “We have 12 million blind people in the world from corneal disease and about 7 million are due to endothelium. We don’t have 7 million corneas, but we could probably come up with 40,000 to 60,000 and get cells from those patients.”
The study comprised 50 patients diagnosed with corneal endothelial disease who were treated with the cell therapy procedure and was broken up into two parts. In IOTA-Part 1, investigators were able to treat 16 patients with a single donor. In IOTA-Part 2, they treated 34 patients with a single donor.
Holland said the first patient treated went from a best corrected visual acuity of 20/500 to 20/40 6 months after the procedure, while central corneal thickness was reduced from 800 µm to 502 µm. Another patient experienced acuity and corneal thickness improvements from 20/2,000 to 20/30 and 891 µm to 557 µm, respectively.
Researchers will also assess patients over the course of 12 months to monitor the safety and efficacy of the treatment.
Holland said they are planning further clinical trials in the United States to move toward approval.
“It has the potential to be the treatment of choice for all endothelial disease,” he said. “What really excites us is this potential to be the solution to world corneal blindness, which we don’t have.”
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Holland EJ. The Richard L. Lindstrom, MD medal lecture: A cornea odyssey – challenges and triumphs. Presented at: American Society of Cataract and Refractive Surgery meeting; July 23-27, 2021; Las Vegas.
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