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    What’s new in corneal surgery in 2015

    Collagen crosslinking led discussions, but corneal transplant techniques were a close second

    Corneal surgeons thought 2015 would be the year that collagen crosslinking (CXL) for the treatment of keratoconus would be approved in the United States, but the FDA’s decision on Avedro’s KXL system is not expected until April 2016.

    “I’m hopeful we’ll see an FDA approval for crosslinking in the next year,” said Jonathan H. Talamo, MD, of Mass. Eye and Ear, Boston. Part of the difficulty in getting a de

    vice for keratoconus approved is that keratoconus itself is an orphan condition and there are not a lot of companies pursuing it, he said.

    The company, however, seems determined to work with the FDA to get the KXL—under review for not only progressive keratoconus, but corneal ectasia following refractive surgery—approved and in the hands of surgeons, he noted. The company received support for approval in both indications in February, but the FDA had concerns about the design of the device.

    News: CA-CXL now including candidates with thin corneas

    “There were no clinical questions on the safety or efficacy of the procedure as demonstrated in the U.S. multicenter clinical trial,” said Peter S. Hersh, MD, of The Cornea and Laser Eye Institute-Hersh Vision Group, Teaneck, NJ, who serves as medical monitor for Avedro.

    “It’s hard to believe that crosslinking is not approved yet in this country,” said Ernest W. Kornmehl, MD, of Kornmehl Laser Eye Associates, Brookline, MA, as crosslinking is already approved in several European countries and in China. He believes the data with results that support the need for approval will make 2016 the year a device enters the U.S. market.

    “Clearly, ophthalmology, corneal surgeons, and keratoconus patients all are awaiting this with great eagerness, especially our patients,” Dr. Hersh said. “From having done a lot of crosslinking and being monitor of these trials, this is clearly a procedure that is efficacious for the patients and the one thing that we would now have to decrease disease progression in these patients.”

    Next: Crosslinking in the United States

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