EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.
Issue link: https://digital.eyeworld.org/i/1529000
66 | EYEWORLD | WINTER 2024 C ORNEA we did the trial without the support of industry," she said. She added that it was the first trial of this kind using epithelial cells that are autolo- gous, so there isn't any rejection. Dr. Jurkunas said that next step will be to go to the FDA to determine if a Phase 3 clinical trial is needed. Most therapies require a Phase 3 trial, she said, adding that the therapy has so far shown that it's safe and feasible. One key factor still to be determined is where manufacturing for this therapy would occur—at one center or multiple centers in the country. It does require quite a lot of resources to manufacture it, she said. Dr. Jurkunas noted that this therapy is dif- ferent from a standard corneal transplant. With the disease, a standard corneal transplant is going to fail right away because you don't have healthy stem cells, so patients in need of this therapy may need a regular transplant and this transplant together. Looking to future developments with this treatment, Dr. Jurkunas said a next step could be investigating how to do this with allogeneic cells, for patients who have bilateral LSCD. A treatment like this would take cells from a ca- daveric donor and culture, possibly with similar methods or with modifications. This would be helpful, she said, because of the prevalence of bilateral cases, but by using another donor, you would need to factor in the possibility of rejec- tion as well. This is a stepping stone for cell therapy in the U.S., she said. "Our regulatory requirements are stringent, and this is the first time we're using stem cell therapy in cornea." She's interested to see the other therapy options being developed for endothelial cells as well. If you have a cell therapy for endothelial cells, you wouldn't need as many corneal cells or cadaveric donors. "There are regulatory hurdles that one has to overcome, but once we have one product, it's always easier for other products to get approved and other technologies to be developed, so I think it's definitely a stepping stone for that," she said. continued from page 65 You might not carry this magazine with you everywhere, but EyeWorld is always at your fingertips. Full issues Online Exclusives Weekly updates WWW.EYEWORLD.ORG