Glaukos Corporation announced positive three-year results from its GLK-202-03 extension study evaluating Epioxa, an epithelium-on corneal cross-linking therapy for keratoconus. Following a single treatment, patients demonstrated a sustained 1.9 diopter improvement in maximum corneal curvature and meaningful visual acuity gains, with 29% of eyes gaining two or more lines. The therapy maintained a favorable safety profile with no serious adverse events reported over the three-year period.
Epioxa three-year extension study
- ▪In the Glaukos Corporation three-year extension study, 29% of treated eyes gained two or more lines of best-corrected visual acuity from baseline, and 20% gained three or more lines.
- ▪The Glaukos Corporation GLK-202-03 extension study followed 38 eyes from 35 subjects for three years after a single Epioxa treatment, with 92% of eyes completing the year 3 visit.
- ▪Glaukos Corporation reported that Epioxa maintained a favorable safety profile through three years, with no serious adverse events, treatment-related adverse events, or discontinuations due to adverse events.
- ▪In a three-year extension study of Glaukos Corporation's Epioxa treatment, treated eyes demonstrated a sustained 1.9 diopter improvement in maximum corneal curvature from baseline at three years.
About Epioxa therapy
- ▪Epioxa is indicated for epithelium-on corneal collagen cross-linking to treat keratoconus in adults and pediatric patients aged 13 years and older.
- ▪Epioxa is an epithelium-on corneal cross-linking therapy that does not require removal of the corneal epithelium, utilizing an oxygen-supplemented topical therapeutic activated by pulsed UV light.
Epioxa adverse reactions
- ▪Other adverse reactions to Epioxa occurring in 5% to 25% of eyes included corneal opacity, photophobia, punctate keratitis, and eye pain.
- ▪The most common adverse reaction associated with Epioxa in clinical trials was conjunctival hyperemia, which occurred in 31% of cases.
Debatable claims
- ▪A single Epioxa treatment provides sufficient long-term stabilization for progressive keratoconus
- ▪Epithelium-on corneal cross-linking should replace traditional epithelium-off procedures as the standard of care
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