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

On Monday, Glaukos Corporation GKOS received the “Day 74” notification from the U.S. Food and Drug Administration (FDA) acknowledging the previously submitted New Drug Application (NDA) for Epioxa (Epi-on), its next-gen corneal cross-linking iLink therapy for keratoconus, a sight-threatening corneal disease, is sufficiently complete to permit a substantive review.The Prescription Drug User Fee Act goal date for the completion of the FDA’s review of the Epioxa NDA is set for Oct. 20, 2025.Also Read: Glaukos ...