Avedro said today that it won FDA approval for its KXL corneal cross-linking eye treatment and a pair of photo enhancers used with the procedure.
The pre-market approval nod for Photrexa Viscous, Photrexa and the KXL System is for the treatment of progressive keratoconus, a gradual thinning and distortion of the cornea. Boston-based Avedro said the treatment is the 1st and only FDA-approved therapy for the condition.
“This approval marks a tremendous milestone for the treatment of progressive keratoconus,” COO/CFO Brian Roberts said in prepared remarks. “We’re excited to provide ophthalmologists in the United States with these tools to treat this orphan disease. We thank the FDA for their diligent efforts as we worked towards approval. We plan to begin taking orders for the KXL System immediately, and plan to begin shipping our Photrexa products in the next few months as we ramp up our drug manufacturing.”
“Avedro and I look forward to working with U.S. ophthalmologists to raise awareness of our new FDA-approved treatment for progressive keratoconus. Avedro is hosting an evening event during the ASCRS meeting in New Orleans in early May. This will be an opportunity for U.S. ophthalmologists to learn what approval of Photrexa Viscous, Photrexa and the KXL system means to their keratoconic patients,” added chief medical officer Dr. Rajesh Rajpal.