US-based ophthalmic medical device company Avedro has received approval from the South Korean Ministry of Food and Drug Safety (MFDS), for its KXL Cross-Linking System.
The KXL system, which includes the VibeX family of riboflavin formulations, has been developed to perform Lasik Xtra and accelerated cross-linking for keratoconus and post-Lasik ectasia.
Avedro CEO David Muller said: "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."
According to Avedro, 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.
To achieve accelerated corneal cross-linking, the procedure combines riboflavin ophthalmic solution with UVA irradiation from Avedro’s KXL device.
Accelerated cross-linking holds the ability to halt progression of the condition in the early stages, for keratoconus and ectasia patients.