IMPORTANT SAFETY INFORMATION
Photrexa® Viscous (riboflavin 5’-phosphate in 20% dextran ophthalmic solution) and Photrexa® (riboflavin 5’-phosphate ophthalmic solution) are indicated for use with the KXL System in corneal collagen cross-linking (CXL) for the treatment of progressive keratoconus and corneal ectasia following refractive surgery.
LIMITATIONS OF USE
The safety and effectiveness of CXL has not been established in pregnant women, women who are breastfeeding, patients who are less than 14 years of age and patients 65 years of age or older.
Photrexa Viscous and Photrexa should be used with the KXL System only.
WARNINGS AND PRECAUTIONS
Ulcerative keratitis can occur. Patients should be monitored for resolution of epithelial defects.
In progressive keratoconus patients, the most common ocular adverse reactions in any CXL treated eye were corneal opacity (haze), punctate keratitis, corneal striae, corneal epithelium defect, eye pain, reduced visual acuity, and blurred vision. In corneal ectasia patients, the most common ocular adverse reactions were corneal opacity (haze), corneal epithelium defect, corneal striae, dry eye, eye pain, punctate keratitis, photophobia, reduced visual acuity, and blurred vision.
These are not all of the side effects of Photrexa® Viscous, Photrexa® and the CXL treatment. For more information, see Prescribing Information.
You may report an adverse event to Avedro by calling 1-844-528-3376, Option 1 or you may contact the U.S. Food and Drug Administration (FDA) directly at 1-800-FDA-1088.