AMSTERDAM--(BUSINESS WIRE)--Presbia announced today that its Presbia Flexivue Microlens™ has received regulatory approval from the Korean Ministry of Food and Drug Safety (MFDS) making this new treatment option for the correction of near vision loss available to the South Korean population.
The Presbia Flexivue Microlens™ is a refractive intracorneal lens that treats presbyopia, the loss of near vision that the majority of adults experience as they age. It is designed to reduce or eliminate the need for reading glasses.
With this approval, the Presbia Flexivue Microlens™ is now available for commercial use in South Korea in addition to more than 40 other countries across Europe, Latin America, the Middle East, and Africa. Presbia is currently undergoing a Clinical Study under the United States Food and Drug Administration to gain approval in the U.S.
“This MFDS approval offers a new treatment option for presbyopia patients in South Korea and represents a milestone for the growing availability of our microlens around the world,” said Zohar Loshitzer, President of Presbia.
Presbia is being represented by Nevis Medical, a leading distributor of ophthalmic medical devices and products that will oversee the distribution of the Presbia Flexivue Microlens™ in South Korea.
ABOUT PRESBIA AND THE PRESBIA FLEXIVUE MICROLENS™
Presbia is a leading ophthalmic-device company focused on the development of solutions for presbyopia, the age-related loss of the ability to read or focus on near objects. Chief among these approaches is the Presbia Flexivue Microlens™, a 3mm-diameter lens implanted using femtosecond laser technology. The procedure requires no general anesthesia and typical recovery periods are only a few days. The Presbia Flexivue Microlens™ utilizes existing equipment and ophthalmic surgical techniques, and requires minimal additional staff training. CAUTION: Investigational device. Limited by Federal (or United States) law to investigational use.
An animated video of the procedure is available at www.presbia.com.