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 in the world for corneal cross-linking with an estimated 1.4 million keratoconic eyes and more than 1000 refractive centers. This represents a virtually untapped opportunity for Avedro,” CEO David Muller said in a press release.
In April, Avedro said the FDA wanted more data on its corneal cross-linking technology, leaving the Boston-based medical device company with a longer U.S. approval timeline.
The FDA’s complete response letter for Avedro’s new drug application for its KXL system outlines “a number of small areas” that need new information, the company said. Avedro didn’t offer details, other than noting that regulators did not seek added information regarding clinical study safety or efficacy data included in the NDA.
The FDA’s move comes despite a late February joint meeting of its Dermatologic & Ophthalmic Drugs and its Ophthalmic Devices advisory panels, which recommended approval for the treatment for both conditions.