The procedure involves the delivery of a single low energy microwave pulse lasting less than one second to the cornea. Energy is applied to the cornea using a dielectrically shielded microwave emitter which contacts the epithelial surface. Through capacitive coupling, the single pulse raises the temperature of the selected region of corneal stroma to approximately 65°C, forming a doughnut-shaped area of collagen shrinkage in the upper 150 microns of the stroma.

Using a patent pending evaporative cooling technique, the Vedera KXS cools the surface of the cornea during the treatment to isolate and protect Bowman’s membrane from the thermal effects of the microwave energy. The lesion created during Keraflex is intended to flatten the central cornea both to decrease the cone in keratoconus and to achieve myopic correction without compromising the biomechanical integrity of the cornea. In order to improve the stability of the cornea with Keraflex, Keraflex KXL includes focal corneal collagen crosslinking.  After the actual Keraflex procedure, riboflavin drops are administered over the treatment area, a mask is applied to protect the central and peripheral areas of the cornea, and ultraviolet light is admistered to crosslink the collagen in the annulus of the Keraflex treatment.

Avedro presented encouraging early clinical results At the 5^thInternational Congress of Corneal Cross Linking for Keratoconus in Leipzig, Germany on December 5^th. Their 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, PhD, FRCPath, FRCOphthal (Hon), 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.

Keraflex KXL has been under clinical study for the correction of myopia since the beginning of the year; the data presented in Leipzig was 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. They also plan to file for an FDA IDE in the United States in mid-2010.

Drs. Marshall and Hersh reported significant corneal flattening and improved corneal smoothness and regularity in all keratoconus subjects. They stressed that these are early results and further analysis is necessary.  It is hoped that Keraflex can help avoid cornea transplants in many patients who otherwise might have no other alternative. In addition to the possibility of improved visual acuity, Keraflex KXL may potentially increase tolerance to contact lens wear and to improve vision correction with glasses among KC patients. Further, this procedure may ultimately help KC sufferers, with no alternative therapeutic options, avoid cornea transplants or at least delay the progression to transplant.

For more information on Avedro, visit www.avedro.com.