Eyeworld

WINTER 2024 | EYEWORLD | 63 C About the physicians Albert Jun, MD, PhD Vernah Scott Moyston Professor and Chair Department of Ophthalmology University of Virginia School of Medicine Charlottesville, Virginia Ula Jurkunas, MD Professor of Ophthalmology Harvard Medical School Boston, Massachusetts Ellen Koo, MD Associate Professor of Ophthalmology Bascom Palmer Eye Institute University of Miami Health System Miami, Florida W. Barry Lee, MD, FACS Cornea Fellowship Director Eye Consultants of Atlanta Atlanta, Georgia C urrently, corneal cell therapy is being investigated as a new approach for patients in need of corneal trans- plantation and treatment for corneal diseases. EyeWorld spoke to several physicians who have experience in this area to hear about specific approaches being developed, current status and results, and the future of these options. Aurion Biotech injectable cell therapy W. Barry Lee, MD, discussing Aurion Biotech injectable cell therapy, said the exact science behind it is proprietary and unknown. The com- pany takes a donor cadaver cornea and harvests the endothelial cells. The cells are transported to a laboratory where they are expanded in vitro. Once the expansion protocols are complet- ed, the cell may potentially be used for treating up to 100 patients with endothelial dysfunction, Dr. Lee said. "Cells are delivered to the surgeon on the morning of the surgery and drawn up in a syringe. The patient is prepared in a sterile environment, and the cells are injected into the anterior chamber of the eye after the anteri- or chamber has been decompressed. A suture is placed in the incision site, and the patient immediately turns over to lie face down for 3 hours. They go home after that time has elapsed with a protective shield over the eye." Aurion Biotech has completed their first U.S. clinical trial aimed at treating corneal edema secondary to endothelial dysfunction, Dr. Lee said. The trial combined neltependocel, expanded human allogeneic endothelial cells, with Y-27632, a ROCK inhibitor, in a prospec- tive, multicenter, randomized, double-masked, parallel-arm, cell dose-ranging study. The medi- cations were administered as a one-time intraca- meral injection in the eye with the primary end- point representing an improvement of 3 lines of visual acuity at 6 months. While all patients have been treated, the company is awaiting final 6-month results for reporting to the FDA. Dr. Lee said it's likely the FDA will review the results of the trial and recommend a Phase 3 clinical trial with the same type of study design. "This trial will likely begin in the second or third quarter of 2025," he said. "While it is diffi- cult to predict FDA recommendations, it may be 2026 or 2027 before the technique is available or at least approved by the FDA. However, the same technology did receive approval in Japan for clinical use in early 2024." The trial for this therapy included pa- tients with endothelial dysfunction with the requirement of pseudophakia and no history of glaucoma, Dr. Lee said. Additionally, he said the majority of patients had Fuchs endothelial corneal dystrophy followed by pseudophakic bullous keratopathy. "The current standard of care for patients with intractable corneal endothelial cell dys- function is a cornea transplant, specifically an endothelial keratoplasty (EK)," Dr. Lee said. "The Eye Bank Association of America Statistical Report showed that EK was the most common cornea transplant done in the U.S. in 2023, with 33,715 EK procedures completed, and Fuchs was the most common disease that required a transplant in 2023. If cell therapy works, the need for this number of transplants in the U.S. and across the world would significantly diminish and potentially could replace the need for EK. This could have a major global impact throughout the world." Dr. Lee said there are other companies currently developing endothelial cell therapies. He noted that Aurion Biotech is slightly further by Ellen Stodola Editorial Co-Director EVOLVING Corneal cell therapy: current status and looking to the future continued on page 64 Brushing technique to remove endothelial cells prior to Aurion Biotech injectable cell therapy in a patient with Fuchs dystrophy Source: W. Barry Lee, MD

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