APPROVED USES Photrexa Viscous® (riboflavin 5’-phosphate in 20% dextran ophthalmic solution) and Photrexa® (riboflavin 5’-phosphate ophthalmic solution) are used with the KXL® System in corneal cross-linking (CXL) to treat eyes in which the cornea, the clear dome shaped surface that covers the front of the eye, has been weakened from the progression of the disease keratoconus or following refractive surgery, a method for correcting or improving your vision.
WHAT WARNINGS SHOULD I KNOW ABOUT CORNEAL CROSS-LINKING? Ulcerative keratitis, a potentially serious eye infection, can occur. Your doctor should monitor defects in the outermost corneal layer of the eye for resolution.
WHO SHOULD NOT RECEIVE CXL? The safety and effectiveness of CXL has not been syudied in pregnant women, women who are breastfeeding, patients who are less than 14 years of age and patients 65 years of age or older.
WHAT ARE THE SIDE EFFECTS OF CXL? TIn progressive keratoconus patients, the most common side effects in any CXL treated eye were haze, inflammation, fine white lines, disruption of surface cells, eye pain, reduced sharpness of vision, and blurred vision. In patients with corneal ectasia following refractive surgery, the most common side effects in any CXL treated eye were haze, disruption of surface cells, fine white lines, dry eye, eye pain, inflammation, light sensitivity, reduced sharpness of vision, and blurred vision.
These are not all of the side effects of the CXL treatment. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
You should report a side effect to Avedro by calling 1-844-528-3376, Option 1 or you should contact the U.S. Food and Drug Administration (FDA) directly at 1-800-FDA-1088.