FDA Greenlights Glaukos’ Epioxa; Company Targets Q1 2026 Rollout
Glaukos’ FDA approval for Epioxa (riboflavin 5'-phosphate) under the 505(b)(2) pathway marks a novel groundbreaking advance in Keratoconus care.
Epooxa provides the ophthalmic community and patients with the first and only FDA approved incision-free topical drug therapy for Keratoconus. This breakthrough innovation brings us an epithelium-on alternative to the traditional corneal cross-linking procedures, which is set to launch in early 2026 with patient access programs.
The Food and Drug Administration (FDA) has approved Epioxa™ HD 0.239% / Epioxa™ 0.177% (riboflavin 5’-phosphate ophthalmic solution) for use in epithelium-on corneal collagen cross-linking for the treatment of Keratoconus in adults and pediatric patients aged 13 years and older, in conjunction with the O2n System and Boost Goggles to deliver oxygen to the eye.