Keraflex Clinical Trial Starts in the US

*August 2012

Keraflex KXL is the newest procedure under investigation for the treatment of keratoconus. The Keraflex® procedure, performed with the Vedera® System is non-incisional and reshapes the cornea without removing any tissue; preserving the biomechanical integrity of the cornea. The Vedera System, for performing the Keraflex KXL procedure, is a CE marked product in Europe.   A US FDA clinical trial using the Vedera System to perform Keraflex KXL for treating Keratoconus just started in New Jersey in August, 2012. (See the Clinical Trials website)

The Keraflex procedure involves the delivery of a single low energy microwave pulse to the cornea lasting less than one second. 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 to decrease the cone in keratoconus and to re-establish to corneal sphericity without compromising the biomechanical integrity of the cornea. In order to improve the stability of the cornea Keraflex KXL includes accelerated corneal collagen crosslinking. After the actual corneal flattening with microwave energy from the Vedera System, riboflavin drops are administered over the treatment area and ultraviolet light is administered using Avedro’s KXL System to crosslink the corneal collagen to lock-in the corneal flattening.

 

In addition to the possibility of improved visual acuity, Keraflex KXL improves corneal sphericity, which 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.

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.

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

Learn more about the newest procedure under investigation for the treatment of keratoconus: keraflex (KXL).