AcuFocus receives KFDA approval for KAMRA inlay to treat presbyopia
Published on May 2, 2012 at 12:19 AM
AcuFocus is pleased to announce they received approval from the Korean
Food and Drug Administration (KFDA) for the KAMRA™ inlay, making this
revolutionary treatment option for near vision loss available to the
Korean population. The majority of people experience loss of near
vision, or presbyopia, as they age. The KAMRA corneal inlay is designed
to only permit focused light rays to enter the eye, allowing patients to
see near and intermediate objects more clearly without glasses. Patients
who have undergone this procedure are once again seeing details such as
mobile devices, labels, and time on a wristwatch with ease.
As a novel technology, the KAMRA inlay went through a very rigorous
approval process. The KFDA required extensive data on clinical results,
safety, device design and biocompatibility. "We are extremely thrilled
to be able to offer this advanced vision correction technology in
Korea," said Ed Peterson, AcuFocus President and Chief Executive
Officer. "The approval from the KFDA is a testament to the excellent
global results achieved with the device."
Over one third of the Korean population is currently struggling with
vision loss associated with presbyopia, and that is projected to
increase to over 42% by the year 2020 [MarketScope]. Until now,
presbyopia could only be treated with reading glasses, contact lenses or
monovision LASIK, all of which compromised distance and intermediate
vision. "The KAMRA inlay is a unique solution, providing presbyopic
patients with visual freedom and less dependency on reading glasses,"
said In-Bum Choi, CEO of Woo Jeon Medical, distributor for the KAMRA
inlay in Korea. "We are confident that the Korean market will be eager
to take advantage of this advanced treatment option and we are excited
to facilitate that process."
To date, the KAMRA inlay has been implanted in more than 11,000 patients
and is now available in 35 countries worldwide. The inlay is available
in select markets across Europe, Asia-Pacific, Middle East and South
America. The KAMRA inlay has received CE mark for use in the European
Union and is an investigational device under FDA Investigational Device
Exemption (IDE) in the United States.