Glaukos completes enrollment in second phase 3 epi-on cross-linking trial
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Key takeaways:
- The primary endpoint is the mean change in maximum corneal curvature from baseline to 12 months.
- Results will support a new drug application by the end of 2024.
Glaukos completed enrollment in the second phase 3 confirmatory pivotal trial for Epioxa, its epi-on corneal cross-linking therapy, according to a press release.
In the multicenter, randomized trial, 312 eyes with progressive keratoconus were randomly assigned to receive Epioxa therapy or placebo and sham control treatment. The primary endpoint is the mean change in maximum corneal curvature from baseline to month 12.
Image: Adobe Stock
Per an agreement with the FDA, the trial will be a success if the difference between the treatment arm and the control arm in the primary efficacy endpoint is statistically significant and the difference is at least 1 D.
Glaukos will use results from the phase 3 confirmatory trial along with the results of a previous phase 3 pivotal trial to support a new drug application submission for Epioxa by the end of 2024.
“The expeditious enrollment completion in the Epioxa phase 3 confirmatory trial, which only commenced earlier this year, is a testament to the favorable risk-benefit profile of this next-generation therapy as well as our team’s hard work in bringing this important therapy one step closer to patients suffering from keratoconus, a sight-threatening corneal disease,” Thomas Burns, Glaukos chairman and CEO, said in the release.
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