Epi-on cross-linking treatment meets primary efficacy endpoint in phase 3 trial
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Epi-on, a next-generation corneal cross-linking iLink therapy for the treatment of keratoconus, demonstrated significant improvement in maximum corneal curvature at 6 months from baseline, according to a Glaukos press release.
Epi-on is designed to reduce procedure time, improve comfort and shorten recovery time. It uses a proprietary novel drug formulation to penetrate the epithelial layer of the cornea to enhance cross-linking. According to the release, Epi-on has a stronger UVA irradiation protocol and delivers increased levels of supplemental oxygen.
A phase 3 pivotal trial was designed to evaluate the safety and efficacy of the iLink Epi-on therapy in slowing the progression of and/or reducing maximum corneal curvature (Kmax) in progressive keratoconus. The study included 189 eyes randomly assigned to the treatment arm and 90 eyes randomly assigned to the control arm. The primary efficacy endpoint was a difference of 1 D or greater between treatment and control arms in the mean change in Kmax from baseline to month 6.
After 6 months, eyes in the placebo group were able to cross over and receive the Epi-on treatment, and then all patients were followed for another 6 months.
Data from the trial showed Epi-on reached its primary efficacy outcome by demonstrating a Kmax treatment effect of –1 D (P = .0004). This effect showed improvement in Kmax by 0.2 D in the treatment arm and worsening in Kmax by 0.8 D in the placebo arm, according to the release.
After 6 months, 98% of placebo patients crossed over to the Epi-on treatment. These patients demonstrated a mean Kmax improvement of 0.3 D at 6 months.
No patient discontinued the trial early due to adverse events.
The trial results are expected to support a new drug application submission in 2022, with Glaukos targeting FDA approval in 2023.
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