Epi-off cross-linking performed with Photrexa® Drug Formulations, Photrexa® Viscous, Photrexa® and KXL® System is the only cross-linking procedure approved by the FDA.
FDA-Approved Cross-linking for Keratoconus is performed with drug products that have been rigorously tested and are specifically controlled and manufactured in an FDA-registered facility and in compliance with FDA guidelines.
Corneal collagen cross-linking is an innovative therapy that has transformed the treatment of progressive keratoconus. Historically, as many as 1 in 5 patients with progressive keratoconus have required a corneal transplant, with more than half needing multiple transplants within 20 years.1, 2
Photrexa® Viscous, Photrexa® and the KXL® System are the first and only therapeutic products for corneal crosslinking which have been FDA approved to treat progressive keratoconus, offering an effective treatment for patients who had no therapeutic options to limit the progression of this sight-threatening disease. The epi-off cross-linking procedure with Photrexa® Viscous, Photrexa® and the KXL® System is FDA-approved, clinically proven, safe and effective.
As with most procedures, adverse events such as corneal haze can occur, and your doctor should monitor you for risks of infection.
1Pramanik S, Musch DC, Sutphin JE, Farjo AA. Extended long-term outcomes of penetrating keratoplasty for keratoconus. Ophthalmology 2006;113(9):1633-8.
2Maharana PK, Agarwal K, Jhanji V, Vajpayee RB. Deep anterior lamellar keratoplasty for keratoconus: a review. Eye Contact Lens 2014;40(6):382-9.
Differences Between FDA-Approved, Off-Label, and Unapproved Cross-Linking for Keratoconus
Epi-off cross-linking requires the removal of the epithelium, the outermost layer of the cornea, to assure penetration of the prescription eye drops. This protocol has been rigorously tested and is the only cross-linking procedure approved by the US Food and Drug Administration (FDA) when performed with Photrexa Viscous, Photrexa and the KXL System.
NOT FDA APPROVED
Epi-on cross-linking is a procedure where the epithelium is left intact. In the U.S., there are currently no epi-on cross-linking procedures that are FDA approved.
The use of any drug(s) other than Photrexa® Viscous and Photrexa® or any device other than the KXL® System for corneal cross-linking is not FDA approved, except as part of an investigational new drug (IND) study.