Non-surgical procedure Keraflex could cure keratoconus without damaging cornea: Avedro

Keraflex KXL, a non-surgical investigational treatment procedure against keratoconus by Avedro has shown encouraging results in clinical studies.

Keratoconus 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. Keratoconus is a progressive condition which can lead to cornea transplantation in some patients.

Keraflex is non-incisional procedure that reshapes the cornea without removing any tissue.

Initial treatment results from the first group of Keraflex KXL patients reported significant corneal flattening and improved corneal smoothness and regularity in all keratoconus subjects.

“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,” stated Prof. Ömer Faruk Yilmaz, MD of Beyoglu Eye Research and Training Hospital in Istanbul, Turkey.

Keraflex KXL procedure 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, he added hoping that Keraflex could help avoid cornea transplants in many patients who otherwise might have no other alternative.

Keraflex KXL treatment can not only 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.

Keratoconus patients are currently faced with limited refractive treatment options.

Keraflex KXL has been under clinical study for the correction of myopia since the beginning of the year, the data presented during the 5th International Congress of Corneal Cross Linking for Keratoconus in Leipzig, Germany on December 5th, 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, Avedro said in a press release.

Avedro plans to file for an FDA IDE in the United States in mid-2010.

Avedro, a privately held medical device company based in Waltham, MA, is developing the science of Thermo-biomechanics for therapeutic medical applications.

Keraflex KXL, a non-invasive, incision-less refractive correction procedure is the first technology that Avedro has developed from its Thermo-biomechanics platform.

Keraflex KXL is currently under clinical investigation in Europe for treating myopia and keratoconus.

Because it is non-incisional and preserves the biomechanical integrity of the cornea, Keraflex KXL is anticipated to substantially broaden the surgical vision correction market by appealing to people with low to moderate myopia who have never considered LASIK or who have opted out of LASIK.