Avedro Announces the Start of Two New US FDA Trials for Accelerated Cross-linking

Avedro Announces the Start of Two New US FDA Trials for Accelerated Cross-linking

November 12, 2013

Lasik with Cross-linking and Pulsed Accelerated Cross-linking

WALTHAM, Mass.--(BUSINESS WIRE)--Avedro Inc., a Boston-based ophthalmic medical device and pharmaceutical company, announces today that the first patients have been treated in two new US clinical trials: Lasik with Cross-linking and Pulsed Accelerated Cross-linking.

Lasik with cross-linking is a two minute procedure performed in conjunction with a standard Lasik procedure to investigate if 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.

Rajesh K. Rajpal, MD, of See Clearly Vision in the Washington, DC area and a member of Avedro’s Medical Advisory Board stated, “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. 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 US.” 

“Outside of the United States, Lasik Xtra is becoming increasingly embraced by refractive surgeons and patients alike,” said David Muller, PhD, CEO of Avedro. “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 new FDA trial for Pulsed Accelerated Cross-linking investigates pulsed UVA light to treat keratoconus. Avedro’s science team discovered that pulsed, rather than continuous UVA light, is important when using higher power accelerated cross-linking, such as that available with Avedro’s KXL® System.

“I am pleased to be the first US surgeon to begin enrolling keratoconus patients with Avedro’s pulsed accelerated cross-linking using its KXL System,” said Michael Raizman, MD, Ophthalmic Consultants of Boston, and a member of Avedro’s Medical Advisory Board. “Avedro’s pulsed accelerated cross-linking is already being routinely used internationally with excellent outcomes.”

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

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

About Avedro, Inc.

Avedro is a privately held medical device and pharmaceutical company advancing the science and technology of corneal cross-linking and refractive correction. Avedro’s products include capital equipment and related single dose pharmaceuticals. Those products are currently used in a procedure known as Lasik Xtra. Over 75,000 surgeries have been successfully performed outside the US using Avedro’s KXL System. The KXL System’s accelerated cross-linking, in combination with its pharmaceuticals, is also used to treat several important and debilitating ophthalmic pathologies outside the United States.

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 proprietary single dose pharmaceutical formulations.

Avedro’s KXL System and single dose pharmaceutical products are currently being used in three Phase III US clinical trials involving over 100 US clinical sites. Avedro products are not for sale in the US.