Riboflavin 5'-Phosphate

Sold as Photrexa Viscous In Dextran 20%. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 1 application for Riboflavin 5'-Phosphate (sold as Photrexa Viscous In Dextran 20%), first approved Jul 15, 2016, with 0 new uses approved and 0 published complete response letters.

First approved: Jul 15, 2016
Applications: 1
New uses approved: 0
Complete response letters: 0

Orphan Designations (FDA)

2 designations, 1 approved for the designated use; see all orphan designations

Treatment of corneal ulcersGlaukos Corporation · designated Sep 21, 2021
Treatment of keratoconusGlaukos Corporation · designated Sep 2, 2011 · approved Oct 17, 2025

Shortages

FDA's drug shortage list, as of Nov 13, 2026

Shortage	Status	First posted	Updated
Riboflavin 5-phosphate Ophthalmic Solution	To Be Discontinued	Jan 20, 2026	Jan 20, 2026

Clinical Trials

4 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Viability Assessment Using FMN Measured in Perfusate and Bile During Normothermic Machine PerfusionLiver Transplant Disorder · The Cleveland Clinic	—	Recruiting	Jan 2, 2026
Pretreatment to Promote Graft Survival After Subsequent High-risk Corneal Transplantation [CrossCornealVision]Corneal Transplantation · Claus Cursiefen	Not applicable	Recruiting	May 23, 2023
B-Complex: A Nutraceutical SANS CountermeasureOptic Disc Edema, Endothelial Dysfunction · National Aeronautics and Space Administration (NASA)	Phase 1	Recruiting	May 9, 2022
A Randomized Clinical Trial of Ex Vivo Corneal Cross-Linking of Donor Keratoplasty Tissue for Keratoconus Used for Keratoplasty in Keratoconus PatientsKeratoconus · Joseph B. Ciolino, MD	Not applicable	Not yet recruiting	Oct 12, 2020

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Jul 15, 2016	Photrexa Viscous In Dextran 20%/Photrexa, Photrexa Viscous In Dextran 20%NDA 203324 · Efficacy (new indication or use)	Glaukos	3	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA