Epioxa meets primary efficacy endpoint in second phase 3 confirmatory trial
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Glaukos announced that Epioxa, its next-generation corneal cross-linking iLink therapy for the treatment of keratoconus, demonstrated statistically significant improvement from baseline vs. placebo in maximum corneal curvature at 12 months.
According to a company press release, this second multicenter, phase 3 confirmatory trial randomly assigned 312 eyes in a 2:1 ratio to receive Epioxa therapy or placebo/sham procedure to assess the treatment’s safety and efficacy in progressive keratoconus.
Topline results showed that Epioxa demonstrated a Kmax treatment effect of –1.00 D at 12 months (P < .0001), the release stated. In addition, the treatment was well-tolerated, with 91.5% of treatment participants completing the trial compared with 90.9% of control participants. No ocular serious adverse events were reported and no treatment participants discontinued due to an adverse event.
“These results further underscore our view that Epioxa may provide the ophthalmic community and keratoconus patients with the first FDA-approved, noninvasive, bioactivated drug treatment alternative designed to reduce procedure time, improve patient comfort and shorten recovery time,” Thomas Burns, Glaukos chairman and CEO, said in the release.
The company noted that these results, in addition to those from the first completed phase 3 pivotal trial, are expected to support an NDA submission for Epioxa by the end of this year. Glaukos recently completed a pre-NDA meeting with the FDA, after which the agency agreed that the company’s two phase 3 trials would support an NDA submission and review.
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