EPIOXA CROSS-LINKING
riboflavin 5-phosphate ophthalmic · KIT · Glaukos Corporation
EPIOXA CROSS-LINKING is a kit containing riboflavin 5-phosphate ophthalmic, taken ophthalmic. Manufactured by Glaukos Corporation.
Key Facts
- Brand Name
- EPIOXA CROSS-LINKING
- Generic Name
- riboflavin 5-phosphate ophthalmic
- NDC Code (Product)
25357-024- Manufacturer
- Glaukos Corporation
- Dosage Form
- KIT
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- NDA219910
- Marketing Start
- 01/16/2026
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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 ( 1 ).
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Apply topical anesthetic and insert a lid speculum ( 2 ). Using a cellulose spear sponge soaked with EPIOXA HD, remove the mucin layer from the corneal surface without debriding the corneal epithelium (epithelium-on) by swiping the sponge 4 to 10 times horizontally and vertically ( 2 ). Apply two drops of EPIOXA HD topically on the eye every 60 seconds for 4 minutes (STEP 1), followed by two drops of EPIOXA topically on the eye every 30 seconds for 6 minutes (STEP 2) ( 2 ). Gently rinse the corneal surface with approximately 5 mL of balanced salt solution (BSS) ( 2 ). Perform ultrasound pachymetry. If corneal thickness is less than 325 microns, irradiation should not be performed ( 2 ). Apply the Boost Goggles and turn on the oxygen flow. Refer to the Boost Goggles User Guide ( 2 ). Center the optical head of the O 2 n System over the cornea and irradiate the eye as per the instructions in the O 2 n System Operator's Manual . The O 2 n System automatically delivers irradiation to the eye for 11 minutes 6 seconds at 30 mW/cm 2 with an on/off cycle of 1 second UV-A on/ 1 second UV-A off at a wavelength of 365 nm ( 2 ). Instill BSS on the cornea every 2 min…
Contraindications
4 CONTRAINDICATIONS Hypersensitivity ( 4.1 ) Aphakic and pseudophakic patients without a UV-blocking intraocular lens ( 4.2 ) 4.1 Hypersensitivity EPIOXA HD and EPIOXA are contraindicated in patients with known hypersensitivity to benzalkonium chloride or any ingredients in EPIOXA HD and EPIOXA. 4.2 Aphakic and Pseudophakic Patients Epithelium-on corneal collagen cross-linking is contraindicated in aphakic patients and pseudophakic patients without a UV-blocking intraocular lens.
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Herpetic keratitis [see Warnings and Precautions (5.1) ] The most common adverse reaction was conjunctival hyperaemia (31%). Other adverse reactions, occurring in 5% to 25% of eyes included: corneal opacity (haze), photophobia, punctate keratitis, eye pain, eye irritation, increased lacrimation, corneal epithelium defect, eyelid oedema, corneal striae, visual acuity reduced, dry eye, and anterior chamber flare ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact GLAUKOS CORPORATION at 1-888-404-1644 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of EPIOXA HD and EPIOXA in the epithelium-on corneal collagen cross-linking procedure with UV-A irradiation and supplemental oxygen was evaluated in two randomized, parallel-group, sham procedure/vehicle-controlled tria…
Frequently Asked Questions
What is EPIOXA CROSS-LINKING used for?
EPIOXA CROSS-LINKING contains riboflavin 5-phosphate ophthalmic. It is a kit taken ophthalmic. Consult your doctor for specific uses.
Is EPIOXA CROSS-LINKING a controlled substance?
EPIOXA CROSS-LINKING is not classified as a controlled substance by the DEA.
What is the generic name for EPIOXA CROSS-LINKING?
The generic name for EPIOXA CROSS-LINKING is riboflavin 5-phosphate ophthalmic. There are 1 other brand versions of riboflavin 5-phosphate ophthalmic.
What is the NDC code for EPIOXA CROSS-LINKING ?
The NDC (National Drug Code) for EPIOXA CROSS-LINKING is 25357-024, listed by Glaukos Corporation.