44 EyeWorld Asia-Pacific | March 2025 Currently, corneal cell therapy is being investigated as a new approach for patients in need of corneal transplantation 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 company 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 completed, 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 anterior 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 prospective, multicenter, randomized, double-masked, parallel-arm, cell dose-ranging study. The medications were administered as a one-time intracameral injection in the eye with the primary endpoint 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 difficult 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.” CORNEA by Ellen Stodola, Editorial Co-Director Corneal Cell Therapy: Current Status And Looking To The Future 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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