PHOTREXA VISCOUS IN DEXTRAN 20% (riboflavin 5'-phosphate)
**EPIOXA HD** and **EPIOXA** (riboflavin 5’-phosphate ophthalmic solutions) are photoenhancers indicated for use in epithelium-on corneal collagen cross-linking for the treatment of keratoconus. They are approved for use in adults and pediatric patients aged 13 years and older and must be used in conjunction with the O2n System and Boost Goggles. The treatment helps manage keratoconus by facilitating the strengthening of corneal collagen fibers.
How PHOTREXA VISCOUS IN DEXTRAN 20% Works
EPIOXA HD and EPIOXA contain riboflavin 5'-phosphate, which functions as a photoenhancer during the cross-linking procedure. When exposed to specific clinical conditions (UVA light and oxygen), the riboflavin generates singlet oxygen. This reactive oxygen species is responsible for creating the covalent cross-links within the corneal collagen stroma, thereby increasing the biomechanical stability of the cornea.
Details
- Status
- Prescription
- First Approved
- 2016-04-15
- Routes
- OPHTHALMIC
- Dosage Forms
- SOLUTION/DROPS
PHOTREXA VISCOUS IN DEXTRAN 20% Approval History
What PHOTREXA VISCOUS IN DEXTRAN 20% Treats
1 indicationsPHOTREXA VISCOUS IN DEXTRAN 20% is approved for 1 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Keratoconus
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03245853 | 20170265 | Ph 4 | completed | Epi-On Corneal Crosslinking for Keratoconus |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PHOTREXA VISCOUS IN DEXTRAN 20% FDA Label Details
Indications & Usage
FDA Label (PDF)PHOTREXA VISCOUS IN DEXTRAN 20% is indicated for the treatment of Keratoconus.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.