FDA Sets Decision Date For Glaukos' Keratoconus Treatment Without The Need Of Surgery

Core Insights - Glaukos Corporation received FDA notification for the New Drug Application (NDA) of Epioxa, a next-gen corneal cross-linking therapy for keratoconus, allowing for substantive review [1] - The FDA's review completion goal date for Epioxa is set for October 20, 2025 [1] - The acceptance of the NDA is a significant step towards providing the first FDA-approved, non-invasive corneal cross-linking drug therapy for keratoconus patients [2] Clinical Data - The NDA submission includes data from two Phase 3 pivotal trials that met primary efficacy endpoints and showed favorable safety and tolerability profiles [3] - Epioxa employs a proprietary drug formulation designed to penetrate the corneal epithelial layer, along with a stronger UV-A irradiation protocol and supplemental oxygen to enhance cross-linking [4] Market Reaction - Following the news, Glaukos' stock price increased by 25%, reaching $157.36 in premarket trading [4]