Avedro wins Chinese approval for KXL eye treatment

Avedro said today it won Chinese Food and Drug Administration approval for its KXL cross-linking eye treatment device for treating keratoconus and post-lasic ectasia. Avedro said the clearance made the KXL system the 1st and only corneal coss-linking device to win approval in the People’s Republic of China. “As the 1st ophthalmic surgeon in China to use the KXL System for corneal cross-linking, I have been clinically evaluating its safety and effectiveness for almost 3 years and found all related corneal parameters to be made more stable by cross-linking. I am very pleased with the approval of the KXL System because it now allows all patients in China who suffer from keratoconus and ectasia full access to corneal cross-linking,” Dr. Zhou Xing Tao, MD of Shanghai, China’s Eye & ENT Hospital of Fudan University said in a prepared statement. Chinese approval of the system was a joint, multi-year effort between Avedro and its Chinese distributor Shinesee Ophthalmic Technology Development, the company said. The cross-linking system combines UVA irradiation from the KXL device with riboflavin ophthalmic solution to treat both Keratoconus and post-lasik ectasia which are progressive conditions that can threaten patient’s eyesight. “Securing approval in China is a significant milestone accomplishment for the Avedro team, our ophthalmic clinical investigators in China and our China distribution partner. China is the largest potential market i...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Optical/Ophthalmic Regulatory/Compliance Avedro Inc. Source Type: news