Avedro, Inc. Announces CE Approval for Lasik Xtra™

WALTHAM, Mass.--(BUSINESS WIRE)-- Avedro, Inc. announced today that the Company’s proprietary Lasik Xtra procedure has received CE Approval. Lasik Xtra is a two minute procedure used in conjunction with standard Lasik to restore the biomechanical integrity and strength to the cornea after a Lasik procedure. Lasik Xtra has been successfully used in thousands of Lasik surgeries outside the US.

“Cross-linking within a LASIK procedure using Lasik Xtra is simple, fast and safe,” said A. John Kanellopoulos, MD, a leading refractive surgeon and member of Avedro’s Medical Advisory Board. “In studies we’ll be reporting at ASCRS in April we’ve found that after almost two years of follow-up, hyperopes appear to have a completely different clinical course if we employ prophylactic cross-linking in their LASIK procedures. Hyperopic LASIK typically regresses more than myopic LASIK.”

Lasik Xtra combines VibeX™ (riboflavin ophthalmic solution) with its KXL™ System (UVA irradiation) to achieve accelerated corneal cross-linking during a Lasik procedure. "Avedro has the only cross-linking products specifically CE approved for performing Lasik Xtra and we are pleased to offer those products to a growing number of ophthalmologists and their Lasik patients outside the US,” said David Muller, CEO of Avedro.

About Avedro, Inc.

Avedro is a privately held medical device and pharmaceutical company advancing the science and technology of corneal cross-linking. Avedro recently completed its US-based, multi-centered, Phase III studies of corneal cross-linking for the treatment of progressive keratoconus and corneal ectasia following refractive surgery. Outside the United States, Avedro has commercialized both VibeX and its KXL System for performing Lasik Xtra and accelerated cross-linking. Additionally, Avedro is developing the science of Thermo-biomechanics for therapeutic medical applications. The Keraflex® refractive correction procedure is the first technology developed from the Thermo-biomechanics platform and is a non-invasive, incision-less ophthalmic procedure for flattening the cornea without the removal of tissue. Keraflex offers the unique ability to induce refractive change without weakening the cornea’s biomechanical integrity, as happens with Lasik and other refractive correction procedures. Keraflex is commercially available outside of the United States.

Contact:

Avedro, Inc.

Kristen Gleason, 781-768-3400

kgleason@avedro.com