Glaukos Corporation announced that it has started enrolling participants for the second phase 3 confirmatory of Epioxa (Epi-on), its next-generation corneal crosslinking (CXL) therapy for keratoconus treatment.
Tell me more about Epioxa.
The CXL therapy has already undergone a first phase 3 pivotal trial that met its pre-specified primary efficacy endpoint. The FDA also confirmed those trial results would allow for a submission and review of a potential new drug application (NDA)—coinciding with a second phase 3 trial.
Let’s talk more about that first trial.
The Epi-on multi-center, randomized, placebo-controlled, phase 3 pivotal trial evaluated the safety and efficacy of Glaukos’s iLink (Epi-on) therapy in reducing the progression of maximum corneal curvature (Kmax) in 279 eyes with progressive keratoconus.
The primary efficacy endpoint was a difference of ≥ 1 diopter (D) between treatment and control arms in the mean change in Kmax from baseline to Month 6. (via)
What did they find?
Results demonstrated a statistically significant improvement in Kmax at 6 months from baseline between the treated and placebo-controlled arms, with a Kmax treatment effectiveness of -1.0D (p = 0.0004).
The treatment was generally well-tolerated; the majority adverse events observed were mild, while the most common included conjunctival hyperemia, corneal opacity, photophobia, dry eye, and eye irritation. See here for more.
What do we know about this new trial?
Glaukos expects to finish patient enrollment—with an estimated 290 participants, randomized to receive corneal CXL therapy—by the end of 2023. Stay tuned for more details!