NDA 203324, held by Glaukos. Riboflavin 5'-Phosphate Sodium, Riboflavin 5'-Phosphate.
As of Nov 13, 2026, NDA 203324 (Photrexa Viscous In Dextran 20%/Photrexa, Photrexa Viscous In Dextran 20%), held by Glaukos, was first approved by FDA on Jul 15, 2016, with 3 approved supplements and 0 published complete response letters.
PHOTREXA VISCOUS and PHOTREXA are indicated for use in corneal collagen cross-linking in combination with the KXL System for the treatment of PHOTREXA VISCOUS and PHOTREXA are photoenhancers indicated for use with the KXL System in corneal collagen cross-linking for the treatment of progressive keratoconus and corneal ectasia following refractive surgery. 1.1 Progressive Keratoconus 1.2 Corneal Ectasia Following Refractive Surgery
| Jul 15, 2016 | Original applicationEfficacy (new indication or use) · Priority review | Approved | |
| Apr 15, 2016 | Original applicationNew dosage form · Priority review | Approved |
| Photrexa Viscous In Dextran 20%/PhotrexaEQ 0.146% BASE/ML;EQ 0.146% BASE/ML · solution/drops;ophthalmic | Riboflavin 5'-Phosphate Sodium | RxReference drug |
| Photrexa Viscous In Dextran 20%0.146% · solution/drops;ophthalmic | Riboflavin 5'-Phosphate | RxReference drug |
| Feb 7, 2025 | Supplement 10Labeling · Standard review | Approved | |
| Jan 25, 2019 | Supplement 6Labeling · Standard review | Approved | |
| Oct 29, 2018 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Jul 15, 2016 | Original applicationEfficacy (new indication or use) · Priority review | Approved | |
| Apr 15, 2016 | Original applicationNew dosage form · Priority review | Approved |
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
