Avedro Announces Preparation for Anticipated Hyperopic Lasik Xtra® US Clinical Trial

Avedro Announces Preparation for Anticipated Hyperopic Lasik Xtra® US Clinical Trial

March 13, 2013

WALTHAM, Mass.--()--Avedro today announced that in preparation for its US clinical trial, a select group of US refractive surgeons have just completed Lasik Xtra procedure training under Gustavo Tamayo, MD, at the Bogota Laser Center in Bogota, Colombia. Lasik Xtra is a two minute procedure used in conjunction with standard LASIK to provide added strength and stability to the cornea during and after a Lasik procedure. Already in use throughout the world, Avedro’s Lasik Xtra combines riboflavin (vitamin B2) ophthalmic solution with Avedro’s KXL® System (UVA irradiation) to achieve accelerated corneal crosslinking during LASIK.   

“I have seen the results that my international colleagues are obtaining, and I am enthusiastically awaiting the opportunity to perform hyperopic Lasik Xtra in Avedro’s clinical study,” said Peter Hersh, MD, Hersh Vision Group, Teaneck, NJ and Avedro Medical Monitor.

“I now offer Lasik Xtra to my myopic and hyperopic LASIK patients,” said Gustavo Tamayo, MD, Bogota Laser Center, Bogota, Colombia. “Crosslinking adds stability to my results and does not change the final result.”

A. John Kanellopoulos, MD, Laservision.gr Institute, Athens, Greece, and New York University Medical School, New York, NY, USA stated, “I have found that after two years of follow-up, hyperopes appear to have a more positive clinical course if we employ prophylactic Lasik Xtra in their LASIK procedures.”

“Internationally there is rising momentum for Lasik Xtra among surgeons and patients,” said David Muller, PhD, CEO of Avedro. “Refractive surgeons and Lasik patients are realizing that in only a few minutes, during a standard LASIK procedure, Lasik Xtra can provide added stability to the LASIK correction.”

The group of refractive surgeons who underwent training with Dr. Tamayo included: Peter Hersh, MD; Michael Gordon, MD, Gordon-Weiss-Schanzlin Vision Institute, San Diego, CA; Michael Raizman, MD, Ophthalmic Consultants of Boston; Raj Rajpal, MD, SeeClearly Vision, Washington, DC; and Vance Thompson, MD, Vance Thompson Vision, Sioux Falls, SD.

Over 50,000 Lasik Xtra procedures have been performed world-wide, and the Company’s technology is currently being used in three Phase III clinical studies in the US involving over 100 clinical treatment sites.

About Avedro, Inc.

Avedro is a privately held medical device and pharmaceutical company advancing the science and technology of corneal crosslinking. The Company’s products include capital equipment and related pharmaceutical products. The products are currently used to treat several pathologies as well as to improve Lasik procedure outcomes in a procedure known as Lasik Xtra®. In 2012 there were almost 50,000 Lasik Xtra procedures performed outside the US with Avedro’s products. The Company is preparing to launch a new device platform which will open up significant new procedure opportunities that the Company has already demonstrated in early trials. Outside the US, Avedro has obtained CE Mark for its KXL System and its family of riboflavin products. The Company’s technology is currently being used in three Phase III clinical studies in the US involving over 100 sites. Avedro products are not for sale in the US.

Contacts

Avedro, Inc.
Kristen Gleason, 781-768-3400
kgleason@avedro.com