We are committed to keeping you informed about the latest advancements in keratoconus treatment. In our
last newsletter
,
we discussed the value of clinical trials, outlining who conducts them, their purpose, and potential benefits of participating. Moving forward, we will be highlighting notable clinical trials currently underway. For those interested in identifying and exploring
local trials, you can always search
ClinicalTrials.gov
for more information. Our team of experts regularly reviews newly published clinical trials, and we will continue to share update we believe are significant. The first clinical trial we'd like to highlight is on Epion Therapeutics' ongoing Phase 3 clinical
trial, now recruiting at over 20 ophthalmic sites across the U.S. However, we'd first like to give you some background and updates as it pertains to cross-linking.
FDA-Approved Cross-Linking
Currently, Glaukos iLink is the only FDA-approved corneal cross-linking procedure, which means the procedure has proven safety and efficacy. Because the outer layer of the cornea (the epithelium) serves as a protective
barrier, this procedure requires the removal of the corneal epithelium for the riboflavin solution to be applied, followed by ultraviolet light. This is called epi-off crosslinking and it is considered the gold standard for treatment of progressive keratoconus
by the Cornea Society.
1
More than 100,000 eyes in the U.S. have been treated with the FDA-approved iLink epi-off cross-linking to date. Long-term studies show that eyes treated with epi-off cross-linking remain stable 10 years after treatment.
2
New Cross-Linking Clinical Trials
Leaving the epithelium in place requires different solutions and treatment protocols, but transepithelial (also called epithelium on cross-linking may have the potential to be a more comfortable and less invasive treatment,
with faster recovery of vision afterwards. Two companies in the U.S. are in the process of conducting clinical trials of this type of cross-linking.
Glaukos
Beginning in April of 2018, Glaukos began the first of two Phase 3 studies of its Epioxa transepithelial cross-linking treatment. Enrollment in those studies has already been completed with a total of 591 subjects and the two Epioxa studies
have successfully met their safety and efficacy endpoints. Collection and analysis of 1-year results from the second study is ongoing and the company expects to submit that data for FDA review by the end of this year. Epioxa could potentially be the first
transepithelial cross-linking treatment approved in the U.S. Click below to read the most recent press release regarding its Epioxa status.
