43 EyeWorld Asia-Pacific | March 2025 CORNEA The trial for this therapy included patients 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 dysfunction 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 along in the number of patients treated. Aurion Biotech uses ROCK inhibitors as an addition to the expanded endothelial cells. “Expanded endothelial cells remain the most exciting new technology for endothelial disease,” Dr. Lee said. “Other devices are in development for countries where tissue is not readily available. These devices are in their infancy but could potentially block edema from entering a diseased cornea, preventing bullous keratopathy and corneal decompensation in countries devoid of tissue for transplantation.” Emmecell Injectable Endothelial Cell Therapy Ellen Koo, MD, said, with Emmecell, the cells are isolated from donor corneas, and they are expanded in a GMP manufacturing facility in the U.S. Magnetic nanoparticles render the cells magnetic, and they are shipped overnight in syringes to the clinical site. This cell therapy is a simple injection that can be performed at the slit lamp with topical anesthesia and does not require access to an OR, she said. EO2002 cells are injected into the anterior chamber, and a magnetic patch is placed over the eye for a short period of time. Patients are able to resume normal activities within a few hours. Emmecell has completed enrollment of its randomized controlled clinical trial testing three doses of EO2002, magnetic human corneal endothelial cells. Topline data is expected before the end of this year, and a pivotal trial will launch early next year, Dr. Koo said. She added that there have been no significant safety concerns, and early analysis shows strong signs of efficacy in both BCVA gain and CCT reduction. With the pivotal trial slated to launch in 2025, Dr. Koo said EO2002 will soon reach many more patients. Availability for use outside of research trials would come after the pivotal trial and FDA approval. Dr. Koo said the targeted patient population for this therapy are patients with corneal edema due to endothelial dysfunction, secondary to conditions such as Fuchs dystrophy or pseudophakic bullous keratopathy. “These subjects may be candidates for DMEK, DSAEK, DSO, or PKP, but they don’t want the risk associated with these invasive surgeries, or they may not have access to a cornea specialist,” she said. “EO2002 injections will be able to treat patients at an earlier stage of disease, and by a wider provider base of general ophthalmologists or cornea specialists, delaying or even preventing the need for transplant.” She added that Emmecell’s magnetic cell therapy does not require the surgical step of removing the existing endothelial layer. “This simple injection can be done by any ophthalmologist (not just a cornea specialist), and it can be performed at the slit lamp,” she said. “The recovery is quick with potential for visual gain as early as 1 week. Other treatments require a more invasive surgical procedure, which may result in a slower visual recovery.” In comparison to current options available for these patients, Dr. Koo said that Emmecell’s magnetic cell therapy is a minimally invasive procedure, requiring no access to an OR, as there is no surgical component. “Patients can resume normal activity the same day and are not required to position for days following the procedure, as is required with current treatments,” she said. Injection of endothelial cells in a patient with Fuchs dystrophy using Emmecell injectable cell therapy. Source: W. Barry Lee, MD
RkJQdWJsaXNoZXIy Njk2NTg0