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Avedro Granted Korean Approval for its KXL® Cross-Linking System for Lasik Xtra®

2014年11月07日 PM02:01
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WALTHAM, Mass.

Avedro Inc., a Boston-based ophthalmic medical device and pharmaceutical company announces today that it has been granted approval from the South Korean Ministry of Food and Drug Safety (MFDS, formerly the KFDA) for the company’s KXL Cross-Linking System. The KXL System components include the VibeX family of riboflavin formulations. The KXL device is designed to perform Lasik Xtra and accelerated cross-linking for keratoconus and post-LASIK ectasia.

Lasik Xtra is a three minute procedure performed in conjunction with standard LASIK to restore biomechanical integrity and strength to the cornea after a LASIK procedure. The procedure combines riboflavin ophthalmic solution with UVA irradiation from Avedro’s KXL device to achieve accelerated corneal cross-linking. For keratoconus and ectasia patients, accelerated cross-linking has the ability to halt progression of the condition in its early phases.

Lasik Xtra offers the ability to ‘lock-in’ the treatment outcomes for both my LASIK and PRK patients, offering them additional peace of mind. As one of the early users of the technology in Korea, I’m excited to offer this improved procedure to my patients,” said David Sung Yong Kang, MD of the Eyereum Eye Clinic, Seoul, Korea. He added, “I’ve been asked to join the Avedro Medical Advisory Board and I’m looking forward to working with the Avedro team to develop new applications for corneal cross-linking.”

The approval of the KXL System is the culmination of a two-year effort working with the South Korean Ministry of Food and Drug Safety, which has one of the most comprehensive approval processes in the world.

David Muller, PhD, CEO of Avedro states, “Korea represents a significant market opportunity, with approximately 140,000 LASIK procedures performed annually. This approval allows us to continue to expand our footprint in Asia. We look forward to bringing Avedro’s new treatment options to doctors and patients in Korea.”

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.

Avedro distributes its products in 63 countries through 33 ophthalmic distributors with 115 sales and service representatives. Avedro products that have received CE Mark include: the IROC Innocross UV-X devices, the KXL System for performing Lasik Xtra and accelerated cross-linking, the KXL II™ System for performing PiXL™, and a portfolio of proprietary single dose pharmaceuticals such as the VibeX and MedioCROSS 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.

CONTACT

Avedro, Inc.
David Iannetta, 781-768-3400
diannetta@avedro.com

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