Eyeworld

R EFRACTIVE Reference 1. Hafezi F, et al. Individualized corneal cross-linking with ribo- flavin and UV-A in ultrathin cor- neas: the sub400 protocol. Am J Ophthalmol. 2021;224:133–142. 48 | EYEWORLD | WINTER 2024 vision loss that could be prevented. He said these cases will often make it through insurance approval with an appeal. William Trattler, MD, said one of the major hurdles that came about after FDA approval of crosslinking was a change in mindset. Referring optometrists and comprehensive ophthalmolo- gists had to be educated on careful monitoring of keratoconus and quick referrals for cross- linking. "Our goal has always been to diagnose early to identify patients because if we treat them early we can prevent more significant vision loss," Dr. Trattler said. "If they are more advanced, we can still treat them so they don't get hydrops or more serious complications and need a transplant. It's really been a tremendous technology shift, and I think … the sooner that we can catch patients, the sooner we can treat them, the less morbidity will occur." In addition, Dr. Trattler said that under- standing of who can/should be crosslinked has evolved. "Patients with thin corneas and steep corneas can achieve successful strengthening of their corneas with crosslinking. In the past, there were some theoretical worries about corneas being too thin to undergo crosslinking, but studies have demonstrated that the pa- tients with very thin corneas (even under 300 microns) can safely undergo crosslinking. For example, the sub400 protocol by Farhad Hafezi, MD, has demonstrated that reducing the time for UV light exposure can safely and effectively allow for crosslinking to be performed in cor- neas in the 200 to 400 micron range, 1 " he said. Dr. Rubinfeld added that patients over 30, 40, 50, and even 60 can rapidly progress de- spite information in old textbooks. He empha- sized the need for continued monitoring even into older age. Next up: transepithelial In the U.S., transepithelial crosslinking proto- cols are in clinical trials. "Doctors have been interested in FDA-ap- proved transepithelial crosslinking for a long time because it has the potential to be a faster procedure that may be more comfortable for patients," said Brandon Ayres, MD, who was in- volved in Glaukos' trials. "Without the need for epithelial removal, we might expect more rapid post-treatment healing and visual recovery and a reduction in the already low risk of complica- tions from a less invasive procedure. However, we don't want these benefits to come at the cost of efficacy of the procedure, so I think we all have been awaiting the results of ongoing clini- cal trials with both caution and optimism." In October 2024, Glaukos reported positive topline results from its second, confirmatory Phase 3 pivotal trial for Epioxa, a system that uses a novel riboflavin formulation, a pulsed, higher-intensity UV-A irradiation protocol, and supplemental oxygen. This trial enrolled 312 eyes. According to the company's press release announcing topline results, Epioxa achieved its primary efficacy outcome, "demonstrating a Kmax treatment effect of –1.0 D determined as prospectively defined least square mean Kmax change from baseline in the Epioxa treated arm versus the sham/placebo-controlled arm at the month 12 study endpoint." A New Drug Appli- cation is expected to be submitted to the FDA by the end of 2024. In its first Phase 3 clinical trial for Epioxa, the treatment resulted in a statistically signif- icant 1 D or greater difference in Kmax from baseline to 6 months compared to the control group, demonstrating the ability to stop or reduce keratoconus progression. Epion Therapeutics completed a Phase 2 clinical trial, which enrolled 2,258 participants with corneal ectasia, for its EpiSmart system in 2021 and began a Phase 3 clinical trial in Octo- ber 2023. Michael W. Belin, MD, Chief Medical Officer for Epion Therapeutics, said recruitment continued from page 47 This is a patient undergoing crosslinking with the Glaukos UV light technology. The riboflavin in the cornea fluoresces with the UV light treatment. Source: William Trattler, MD

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