Glaukos Achieves Pipeline Milestone with Enrollment Completion in Phase 3 Confirmatory Trial for Epioxa (Epi-on)
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Monday, June 5, 2023
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“We appreciate the commitment and dedication of the clinical investigators, who played a vital role in helping to achieve this enrollment milestone ahead of our original timing expectations.
Key Points:
- “We appreciate the commitment and dedication of the clinical investigators, who played a vital role in helping to achieve this enrollment milestone ahead of our original timing expectations.
- The study eyes were randomized in a 2:1 ratio to receive Epioxa therapy or placebo and sham procedure control treatment.
- Results from this second Phase 3 confirmatory pivotal trial together with the already-completed first Phase 3 pivotal trial are expected to support Glaukos’ targeted NDA submission for Epioxa by the end of 2024.
- As a reminder, the U.S. FDA has confirmed Glaukos’ first Phase 3 pivotal trial for Epioxa, which met the pre-specified primary efficacy endpoint, would be adequate to support the submission and review of an eventual NDA, in conjunction with this second Phase 3 trial.