KAMRA™ Inlay Receives KFDA Approval

Revolutionary presbyopia treatment will now be available to the Korean market

IRVINE, Calif. - Tuesday, May 1st 2012 [ME NewsWire]

(BUSINESS WIRE)-- 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.

About Presbyopia

Presbyopia, a part of the normal aging process, reduces the ability of the eye to focus on near objects. This condition occurs when the crystalline lens of the eye loses its flexibility, making it difficult to focus on close objects. Presbyopia may seem to occur suddenly, but the actual loss of flexibility takes place over a number of years, usually becoming noticeable in the early to mid-40s. Presbyopia is not a disease and it cannot be prevented. Traditionally, most people with presbyopia use reading glasses to improve their near vision.

About AcuFocus and the KAMRA™ inlay

AcuFocus, Inc., a privately held company located in Irvine, California, developed the KAMRA inlay for the treatment of near vision loss (presbyopia). The KAMRA inlay is an intra-corneal inlay designed to create a small aperture effect, allowing the eye to see near and intermediate objects more clearly while maintaining distance vision. By applying the “depth-of-focus” principle commonly used in photography, the KAMRA inlay controls light transmission, allowing only central rays to reach the retina through a fixed 1.6mm aperture. For more information about the AcuFocus KAMRA inlay please visit www.AcuFocus.com.

About Woo Jeon Medical

Woo Jeon Medical Co., Ltd. is a leading ophthalmic medical device and equipment company in Korea. Woo Jeon Medical has been importing medical devices and equipment from renowned manufacturers in the US, Switzerland, Japan, and Austria for over 20 years and has established exclusive distribution to domestic clinics and hospitals through their nationwide network. For more information about Woo Jeon Medical please visit www.wjm.co.kr.

Contacts

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