US-based ophthalmic medical device firm Avedro has received approval from the South Korean Ministry of Food and Drug Safety (MFDS) for its KXL cross-linking system.
The KXL system, including the VibeX family of riboflavin formulations was developed to carry out Lasik Xtra and accelerated cross-linking for keratoconus and post-Lasik ectasia.
Lasik Xtra is a three minute procedure conducted in conjunction with standard Lasik. It restores biomechanical integrity and strength to the cornea after a Lasik procedure.
In order to achieve accelerated corneal cross-linking, Lasik Xtra combines riboflavin ophthalmic solution with UVA irradiation from the company's KXL device.
Clinic director of Eyereum Eye Clinic David Sung Yong Kang said: "Lasik Xtra offers the ability to 'lock-in' the treatment outcomes for both my Lasik and photorefractive keratectomy (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 patient.
"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."
Accelerated cross-linking has the ability to halt progression of the condition in the early stages, for keratoconus and ectasia patients.
The approval of KXL system is a result of the company's two-year effort working with the South Korean Ministry of Food and Drug Safety.
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."
The company's KXL system and single dose pharmaceutical products are currently being used in three Phase III US clinical trials, involving more than 100 US clinical sites.