What’s on the Horizon for Keratoconus?
The number of keratoconus treatment options is growing, with new techniques and devices in development.
Excerpt Below
Various studies have suggested that the incidence rate of keratoconus is between 0.2 and 4,760 per 100,000 people and 1.5 and 25 per 100,000 people/year.¹ Previous treatment options for the masses included cornea transplant, penetrating keratoplasty, Intacs and various types of lenses-rigid gas permeable lenses, scleral lenses and soft contact lenses for milder cases. But what if every keratoconus patient had a host of novel treatment options available to them?
Corneal collagen cross-linking has been the cutting-edge treatment option for keratoconus,² and a number of ophthalmic medical technology and pharmaceutical companies have been pioneering the latest advancements in corneal cross-linking, and, in some cases, researchers have been developing management techniques in tandem with this technology. To appreciate the scope of the developments in keratoconus management, here’s a list of devices and techniques that may eventually come to your practice.
EpiSmart’s EpiPrep disposable wand (Top) and disposable loading sponge (Bottom).
EpiSmart (Epion Therapeutics)
According to their website, Phase III FDA trials (Apricity A and Apricity B) for Epion’s minimally invasive keratoconus treatment, EpiSmart, commenced in 2023. They plan on enrolling 800 subjects from across the United States, including patients as young as 8 years old, as long as they’ve met the enrollment criteria.
This epi-on platform includes RiboStat, a high concentrated riboflavin/sodium iodide solution. This is administered using EpiPrep, a two-part system including a disposable wand to enhance epithelial permeability and a disposable loading sponge to sustain high drug concentration during stromal loading. This is when the EpiSmart UV-A device is introduced to perform epi-on corneal cross-linking.
This epi-on platform includes RiboStat, a high concentrated riboflavin/sodium iodide solution. This is administered using EpiPrep, a two-part system including a disposable wand to enhance epithelial permeability and a disposable loading sponge to sustain high drug concentration during stromal loading. This is when the EpiSmart UV-A device is introduced to perform epi-on corneal cross-linking.
EpiSmart’s corneal collagen cross-linking system uses an epi-on approach.
During Phase II FDA trials,⁷ Epion researchers enrolled 2,228 subjects who were assessed at six and 12 months postoperatively. The subjects were randomly divided into three different treatment groups, each receiving various doses of UV-A treatment. The doses administered were 2.4 J/cm² over 20 minutes, 3.6 J/cm² over 20 minutes and 3.6 J/cm² over 30 minutes. The primary endpoint observed by the researchers was logMAR CDVA, while secondary endpoints included logMAR UCVA, Kmax and minimum corneal thickness.
Researchers reported that 1,922 subjects were diagnosed with keratoconus and the other subjects had postsurgical or other ectasias. The primary endpoint was achieved and resulted in a significant improvement in CDVA for all groups. UCVA and Kmax secondary endpoints were significant as well, but minimum corneal thickness remained unchanged. Although no serious adverse events were reported, 195 cases (8.7 percent) had at least one adverse event. The most prevalent complication was a mild corneal epithelial defect, which was found in 31 cases (1.4 percent).
Sources
1. Santodomingo-Rubido J, Carracedo G, Suzaki A, et al. Keratoconus: An updated review. Contact Lens and Anterior Eye 2022;45:3.
2. Feldman BH, Halfpenny C, Bernfeld E, et al. Corneal collagen cross-linking. https://eyewiki.aao.org/Corneal_Collagen_Cross-Linking. Accessed on March 28, 2024.
7. Epstein RJ, Belin MW, Gravemann D, et al. EpiSmart crosslinking for keratoconus: A Phase 2 study. Cornea 2023;42:7:858-866.