Glaukos Corp (GKOS) said Monday that the US Food and Drug Administration has accepted its corneal disease drug Epioxa for review, with a goal date of Oct. 10.
Epioxa is a corneal cross-linking iLink therapy for the treatment of keratoconus, a sight-threatening corneal disease.
The application includes data from two phase 3 pivotal trials of Epioxa, which both successfully achieved the pre-specified primary efficacy endpoints and demonstrated favorable tolerability and safety profiles, the company said.
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