IMPORTANT SAFETY INFORMATION

Contraindications

EPIOXA™ HD and EPIOXA™ are contraindicated in patients with known hypersensitivity to benzalkonium chloride (BAC) or any ingredients in EPIOXA HD and EPIOXA. Epithelium-on corneal collagen cross-linking is contraindicated in aphakic and pseudophakic patients without a UV-blocking intraocular lens.

Warnings and Precautions

Corneal collagen cross-linking should be used with caution in patients with a history of herpetic keratitis due to the potential for reactivation of herpes keratitis.

Adverse Reactions

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.

Dosage and Administration

EPIOXA HD and EPIOXA are for topical ophthalmic use. NOT for injection or intraocular use.
EPIOXA HD and EPIOXA are supplied in single-dose syringes. Discard opened syringes after use.
EPIOXA HD and EPIOXA are for use with the O₂n System and Boost Goggles only.
Refer to the O₂n System Operator’s Manual and Boost Goggles User Guide for device instructions.

INDICATIONS AND USAGE

EPIOXA™ HD (riboflavin 5’-phosphate ophthalmic solution) 0.239% and EPIOXA™ (riboflavin 5’-phosphate ophthalmic solution) 0.177% 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 O₂n™ System and the Boost Goggles^®.

Please see full Prescribing Information for EPIOXA HD and EPIOXA at www.Epioxa.com.
You are encouraged to report all side effects to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
You may also call Glaukos at 1-888-404-1644.