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 epioxa is now FDA Approved

Introducing the first and only epithelium-on oxygen-enriched corneal collagen cross-linking therapy for keratoconus

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Frequently Asked Questions

  • What is keratoconus?

    Keratoconus is a progressive disease that causes the cornea to thin and become cone-shaped, leading to visual distortion and, in advanced cases, severe visual impairment.

  • How do I say Epioxa?

    E pee ox’ ah

  • What is Epioxa?

    Epioxa is the only FDA-approved, epithelium-on, corneal collagen cross-linking treatment for keratoconus.

  • How is Epioxa different from other treatments for keratoconus?

    Epioxa is the first and only epithelium-on, oxygen-enriched, corneal collagen cross-linking therapy, approved by the FDA to treat keratoconus.

  • Who is Epioxa for?

    Epioxa is approved to treat keratoconus in adults and pediatric patients aged 13 years and older.

  • Is Epioxa safe and effective?

    Yes, the safety and efficacy of Epioxa were studied in 2 prospective, multicenter, randomized 2:1 sham procedure/placebo-controlled clinical trials, and was approved by the FDA for the treatment of keratoconus in adults and pediatric patients aged 13 years and older. For complete information review full Prescribing Information.

  • What support programs are available for those interested in treatment with Epioxa?

    Glaukos is committed to ensuring all eligible patients have access to treatment with Epioxa. Beginning in January 2026, patient assistance programs will be available for eligible patients.

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.

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.

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.

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.

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.

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.