Epioxa HD/Epioxa Kit

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 ).

Hypersensitivity ( 4.1 ) Aphakic and pseudophakic patients without a UV-blocking intraocular lens ( 4.2 )

4.1Hypersensitivity

EPIOXA HD and EPIOXA are contraindicated in patients with known hypersensitivity to benzalkonium chloride or any ingredients in EPIOXA HD and EPIOXA.

4.2Aphakic and Pseudophakic Patients

Epithelium-on corneal collagen cross-linking is contraindicated in aphakic patients and pseudophakic patients without a UV-blocking intraocular lens.

Herpetic keratitis : Use with caution in patients with a history of herpetic keratitis due to the potential for reactivation ( 5 ).

5.1Herpetic Keratitis

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.

8.1Pregnancy Risk Summary

Animal development and reproduction studies have not been conducted with EPIOXA HD and EPIOXA with the O 2 n System and Boost Goggles. Since it is not known whether the epithelium-on corneal collagen cross-linking procedure can cause fetal harm or affect reproduction capacity, it should not be performed on pregnant women.