CXL Ophthalmics Publishes Data Demonstrating Benefits of Ribostat™ for Transepithelial Cross-linking
Patented Riboflavin and Sodium Iodide combination results in adequate and sufficient riboflavin delivery into the corneal stroma without epithelial removal
Encinitas, CA, May 28, 2021 – CXL Ophthalmics, LLC, a clinical-stage company, today announced the publication of Ribostat™ data in the journal Clinical Ophthalmology. “The Effect of Sodium Iodide on Stromal Loading, Distribution and Degradation of Riboflavin in a Rabbit Model of Transepithelial Corneal Crosslinking”, describes an investigation into the effect of sodium iodide during transepithelial cross-linking. Sodium Iodide was found to increase the concentration of riboflavin in corneal stroma before and during the cross-linking procedure, helping to enable cross-linking without disruption or removal of the epithelium.
Cross-linking is an established method to strengthen the corneas of keratoconus patients using riboflavin (vitamin B-2) and ultraviolet-A (UV-A) light. Traditionally, the corneal epithelium is removed so riboflavin solution can pass into the corneal stroma, where protein crosslinks are formed to strengthen the cornea. More solution is applied during the cross-linking process to replenish riboflavin which degrades upon exposure to UV-A. Ribostat is an investigational fixed-dose combination drug that contains iodide ions to protect riboflavin from breakdown during cross-linking. If approved, Ribostat would be the first drug to use this mechanism to enable trans-epithelial (“epi-on”) cross-linking.
The paper describes the mechanism by which Ribostat preserves riboflavin concentration in the cornea. It goes on to describe controlled experiments that show statistically significant (p<0.001) overall improvements in corneal stromal riboflavin during corneal cross-linking.
The full text is available at https://doi.org/10.2147/OPTH.S300886.
About EpiSmart, Cross-linking and Keratoconus
The patented EpiSmart system, including Ribostat, is designed to optimize cross-linking therapy for keratoconus, allowing minimally-invasive treatment via simultaneous bilateral application of UV light without the need for surgical removal of the corneal epithelium. The safety and efficacy of EpiSmart was investigated in a recently concluded 2,258-subject phase 2 trial, and CXL Ophthalmics is preparing to initiate phase 3 clinical trials for the treatment of keratoconus with EpiSmart.
Corneal collagen cross-linking is a process used to strengthen corneas affected by keratoconus and halt disease progression. Riboflavin (vitamin B2) and ultraviolet light interact to cause new bonds to form between proteins, fortifying the structure of weakened corneas. The currently approved treatment approach is called “epi-off cross-linking” and involves a painful recovery, delayed return of vision and significant risk of scarring or infection. CXL Ophthalmics has developed a system for “epi-on cross-linking” (without removal of epithelium) that could allow for earlier, safer and more convenient treatment, potentially saving vision for millions of patients.
Keratoconus is a bilateral, progressive corneal degenerative disease accompanied by corneal thinning. In later stages, the cornea takes on a bulging, conical shape, leading to irregular astigmatism that is difficult or impossible to correct and results in loss of functional vision. Typical onset of symptoms occurs in the late teens to early twenties but can be manifest in children younger than 10 years old. Based on global epidemiological research, estimates of keratoconus prevalence range from 1:2000 to 1:100. The recent Raine study, performed in Australia, showed a prevalence at 1.2%, which implies a US prevalence of more than 3 million.
About CXL Ophthalmics
CXL Ophthalmics is an ophthalmology-focused medical device and pharmaceutical company dedicated to the discovery, development, and commercialization of innovative treatments for corneal diseases. CXL Ophthalmics’cross-linking system, EpiSmart, functions by photochemically strengthening the cornea. EpiSmart is not approved for commercial use and is currently in clinical trials supervised under an IND on file with the U.S. Food and Drug Administration (FDA). For more information, please visit www.cxlophthalmics.com.
Contact:
CXL Ophthalmics
Edward Parsons, VP Strategy & Business Development
info@cxlophthalmics.com