Treats keratoconus. NDA 219910, held by Glaukos. Riboflavin 5'-Phosphate Sodium.
As of Nov 13, 2026, NDA 219910 (Epioxa Hd/Epioxa Kit), held by Glaukos, was first approved by FDA on Oct 17, 2025, with 0 approved supplements and 0 published complete response letters.
EPIOXA HD and EPIOXA are indicated 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 O 2 n System and the Boost Goggles. EPIOXA HD and EPIOXA are photoenhancers indicated 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 O 2 n System and the Boost Goggles.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 17, 2025 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Epioxa Hd/Epioxa KitEQ 0.239% BASE/ML;EQ 0.177% BASE/ML · solution/drops;ophthalmic | Riboflavin 5'-Phosphate Sodium | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
