CXL Ophthalmics Granted Patents on UV-A Device for Transepithelial (Epi-on) Corneal Cross-linking
Proprietary light cycling features are optimized for cross-linking of intact, undisturbed cornea
Encinitas, CA – CXL Ophthalmics, LLC, a clinical-stage company developing treatments for corneal ectasia, today announced the issuance of its 8th US Patent related to its EpiSmart™ system for Epi-on cross-linking, and the allowance of claims in a related application. U.S. Patent No. 11,033,429 was issued on June 15th, 2021. A Notice of Allowance was received earlier this month for application 16/128,303, which is expected to result in an issued patent later this year. Together, these patents cover CXLO’s technologies for optimal cycling of UV-A light, projection onto the eye with a convenient working distance, and compensating visible-spectrum lights for eye fixation and patient comfort through the EpiSmart treatment light cycles.
The IP was invented by CXLO’s founders and is assigned to, and wholly owned by CXLO.
The EpiSmart system comprises devices for non-disruptive cleansing of the corneal surface without epithelial disruption and homogeneous drug delivery; RiboStat™ (riboflavin 5’-phosphate 0.5% and sodium iodide 0.015%); and a bilateral, simultaneous cycling UV-A light device. All three are now patent-protected technologies. Together, these allow for optimal photochemical cross-linking to strengthen the corneal stroma without invasive removal of the corneal epithelium. Other available techniques surgically remove the epithelial layer to allow in riboflavin and oxygen. With EpiSmart, iodide ions prevent the breakdown of riboflavin, and optimized light cycling allows for oxygen to diffuse through the epithelium when UV-A is dimmed, and to mediate the cross-linking reactions when UV-A is up-cycled.
The company believes its portfolio of patents fully covers the core features of EpiSmart, the most optimal minimally-invasive corneal treatment for keratoconus and other corneal ectasias. This method is under clinical investigation for the treatment of keratoconus to restore visual acuity and prevent vision loss.
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 UV-A 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