Avedro said today it launched the KXL corneal cross-linking system in the U.S., touting the 1st commercial procedure performed with the system and the associated Photexa Viscous and Photexa drugs used with the system.
The company won FDA approval for the device and the associated drugs in April. The Photrexa Viscous, Photrexa and the KXL System are designed 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.
Avedro won a 2nd indication, for treating corneal ectasia following refractive surgery, in July.
“We were thrilled to treat our 1st patients after FDA approval last week in my practice. Avedro shipped the Photrexa products to over 50 locations in the U.S. over the last week, with more shipping each day, and practices are now treating patients. This marks a tremendous milestone and offers new hope to patients in the U.S., to help with their vision challenges and to treat these sight-threatening diseases,” chief medical officer Dr. Rajesh Rajpal said in a press release.
“Avedro’s product launch has been highly anticipated by the keratoconus community as patients can now receive the only FDA-approved cross-linking treatment available in the U.S. The timing is ideal as we prepare for the first World Keratoconus Day taking place on November 10th,” National Keratoconus Foundation exec director Mary Prudden said in a press release.
“This is an exciting time in ophthalmology. We are proud to announce that FDA approved cross-linking treatments are now a reality, and our Photrexa drug products are now available. Clinicians have already started to treat their patients in the U.S. who are suffering from progressive keratoconus or corneal ectasia,” CEO Reza Zadno said in a prepared statement.
Zadno replaces CFO/COO Brian Roberts, the former CFO at Insulet (NSDQ:PODD), who stepped in on an interim basis when David Muller bowed out shortly after Avedro closed a $32 million equity round in November 2015.