Avedro Initiates Keraflex KXL Clinical Trials

Avedro has presented encouraging early clinical results for treating keratoconus, during the 5th International Congress of Corneal Cross Linking for Keratoconus in Leipzig, Germany on December 5th. Keraflex KXL, is non-incisional and reshapes the cornea without removing any tissue.

Keratoconus or KC, is a cone-shaped protrusion and distortion of the cornea that typically begins in the teenage years or 20’s and afflicts millions of people around the world, severely affecting their vision. KC is a progressive condition which can lead to cornea transplantation in some patients.

Initial treatment results from the first group of Keraflex KXL patients, treated by Prof. Omer Faruk Yilmaz, MD of Beyoglu Eye Research and Training Hospital in Istanbul, Turkey, were presented in Leipzig by Prof John Marshall, Emeritus Professor of Ophthalmology King’s College London; and Dr Peter Hersh, Professor of Ophthalmology UMDNJ – New Jersey Medical School and Director, Cornea and Laser Eye Institute – CLEI Center for Keratoconus in New Jersey.

In their presentations, Dr. Marshall and Dr. Hersh reported corneal flattening and improved corneal smoothness and regularity in all keratoconus subjects.

Dr. Hersh said: “Keraflex KXL is a promising new technology to decrease the protruding cone of keratoconus and make the irregular cornea smoother. Our early experience shows improvements in the keratoconic cornea that we have not seen with past technologies. This should help improve vision in patients with keratoconus, a cornea problem that is difficult to correct, as well as improve contact lens wear and vision with glasses. We hope that Keraflex can help avoid cornea transplants in many patients who otherwise might have no other alternative.”

Dr. Marshall added: “I am extremely excited by Avedro’s technology. It has particularly important consequences for the treatment of keratoconus whereby not only can it flatten the cornea, it also has the potential for correcting associated refractive errors without any biomechanical weakening and most unexpectedly, it strengthens the cornea and should prevent or delay any further corneal distortion.”

David Muller, president and CEO of Avedro, said: “It was clear that the discerning conference attendees universally welcomed the new data and were equally excited about the promise of the technology for their keratoconus patients who are currently faced with limited refractive treatment options. While Keraflex KXL has been under clinical study for the correction of myopia since the beginning of the year, the data presented in Leipzig is from a separate keratoconus study that began in November.

“The visually debilitating nature of keratoconus and the lack of refractive correction alternatives for keratoconus patients have prompted the company to accelerate its efforts to make Keraflex KXL commercially available for treating keratoconus patients in Europe as soon as the company receives its CE Mark.”