Research and Development
Clinical Studies
Phase III Program
Epion is preparing to launch Phase III studies to support registration of the EpiSmart™ cross-linking system in the United States. Building on the largest set of clinical studies ever done in corneal cross-linking, these randomized controlled trials will carefully study the clinical benefit of the first optimized Epi-On cross-linking system. The goal is to establish the safety and efficacy of EpiSmart CXL for patients diagnosed with ectasia, so that future patients can be treated before disease robs them of vision.
Phase II Program
CXL-005 completed the enrollment of 2,258 patients in June of 2019. An interim analysis in 2018 showed that EpiSmart-treated keratoconus patients showed statistically significant improvements in best-corrected distance vision at 6 and 12 months post-treatment. The Phase 2 study was conducted under an Investigational New Drug Application (#124062) with the US FDA. It accomplished the final optimization of our cross-linking procedure, and provided data to aid in the design of pivotal trials for product registration.
Of the 784 patients with keratoconus who were followed for 12 months, over 80% had stable or improved vision following EpiSmart treatment.
The results were published in the journal Cornea in July 2023.
CXL-USA Consortium Trials
The CXL-USA consortium conducted a series of IRB-approved clinical studies between 2009 and 2016. Over 13,000 eyes were treated in these studies, first using available cross-linking methods, and then innovating and improving them. The result is EpiSmart, the world’s first complete Epi-On cross-linking system optimized for patient comfort and safety as well as clinical efficacy. Clinical results using the final EpiSmart protocol have shown long-term vision stability in patients.
Doyle Stulting, MD and collaborators analyzed patients studied at the Woolfson Eye Institute in Atlanta, Georgia. 592 eyes in 388 patients with keratoconus or post-LASIK ectasia were studied after EpiSmart treatment. The patients showed statistically significant improvements in visual acuity and other signs of ectasia at one and two years post-treatment.
Results were published in the Journal of Cataract and Refractive Surgery in November 2018.
Laboratory Science
Ribostat and EpiPrep™ applicators allow for homogenous trans-epithelial loading
The first challenge encountered after the discovery of corneal collagen cross-linking was the impermeability of the corneal epithelium to riboflavin, the photocatalyst necessary for cross-linking to occur. Earlier techniques remove the epithelium in order for the riboflavin to pass into the corneal stroma. EpiSmart uses a novel drug formulation and applicator system to accomplish this without the pain and complication of surgical removal of the epithelium.
Experiments were performed at an independent laboratory to compare the absorption of riboflavin using two cross-linking methods. The advantages of RiboStat are seen in an increased rate of riboflavin absorption and uniform loading of the stroma.
Ribostat and EpiPrep™ applicators allow for homogenous trans-epithelial loading
The first challenge encountered after the discovery of corneal collagen cross-linking was the impermeability of the corneal epithelium to riboflavin, the photocatalyst necessary for cross-linking to occur. Earlier techniques remove the epithelium in order for the riboflavin to pass into the corneal stroma. EpiSmart uses a novel drug formulation and applicator system to accomplish this without the pain and complication of surgical removal of the epithelium.
Experiments were performed at an independent laboratory to compare the absorption of riboflavin using two cross-linking methods. The advantages of RiboStat are seen in an increased rate of riboflavin absorption and uniform loading of the stroma.
EpiSmart is an investigational drug-device combination product. EpiSmart and its components (Epiprep, Ribostat, and UVA Device) are not yet approved by the Food and Drug administration or by other regulatory bodies.
Results were presented at ASCO on May 1, 2019 in Vancouver, Canada, and published in Clinical Ophthalmology.