FDA Trials for Accelerated Cross-linking Underway in U.S.

Avedro Inc., a Boston-based ophthalmic medical device and pharmaceutical company, have begun treating patients in two U.S. clinical trials studying accelerated cross-linking.

The first new trial will analyze Lasik with cross-linking, a two-minute procedure performed in conjunction with a standard Lasik procedure. The study, according to clinicians, is designed to determine whether cross-linking following Lasik reduces regression of refractive outcome in patients with hyperopia or hyperopic astigmatism. Lasik with cross-linking (Lasik Xtra) is currently approved outside the United States and has been used successfully in more than 75,000 Lasik procedures.

“During the past two years I’ve had the opportunity to perform Lasik Xtra with ophthalmic colleagues outside of the United States and have been impressed with the outcomes I witnessed,” said Rajesh K. Rajpal, M.D., of See Clearly Vision in the Washington, D.C., area and a member of Avedro’s Medical Advisory Board. “As the first refractive surgeon to perform Lasik Xtra in the United States in Avedro’s new FDA trial, I am looking forward to evaluating Lasik Xtra in this controlled clinical study in the U.S.”

“Outside of the United States, Lasik Xtra is becoming increasingly embraced by refractive surgeons and patients alike,” Avedro CEO David Muller, Ph.D, said. “Our international experience with Hyperopic Lasik has been very encouraging and we look forward to repeating those results in our new Lasik Xtra FDA trial.”

Avedro’s second trial for Pulsed Accelerated cross-linking will investigate pulsed ultraviolet A (UVA) light to treat keratoconus. Avedro’s science team discovered that pulsed rather than continuous UVA light is important in higher power accelerated cross-linking (which can be found in Avedro’s KXL System).

“U.S. surgeons are awaiting the possibility of both Accelerated Cross-linking and Lasik Xtra,” Peter Hersh, M.D., Hersh Vision Group, of Teaneck, N.J., and Avedro Medical Monitor. “We see the results that our international colleagues are obtaining, and we are pleased to have begun U.S. trials to provide access to these procedures for select U.S. patients.”

Further information about the Lasik Xtra trial and the Pulsed Accelerated Crosslinking trial can be found at www.clinicaltrials.gov.

Avedro is a privately held medical device and pharmaceutical company based in Waltham, Mass., that develops corneal cross-linking and refractive correction technology. Avedro’s products include capital equipment and related single dose pharmaceuticals. Those products currently are used in Lasik Xtra procedures. More than 75,000 surgeries have been performed outside the United States using Avedro’s KXL System.

Avedro distributes its products in 62 countries through 33 ophthalmic distributors with 115 representatives. Avedro products that have received CE Mark include the KXL II System for performing PiXL, the KXL System for performing Lasik Xtra and Accelerated Cross-linking, and the Avedro family of formulations.

Avedro’s KXL System and single dose products currently are being used in three Phase III U.S. clinical trials involving more than 100 U.S. clinical sites.