IRVINE, CA – June 9, 2014 – AcuFocus (www.acufocus.com) the global leader in corneal inlay technology, announced today that deliberations of the U.S. Food and Drug Administration (FDA) Ophthalmic Devices Advisory Panel resulted in a determination that the benefits of the KAMRA inlay outweigh the risks for patients suffering vision loss as a result of presbyopia. The vote was cast last Friday after the panel reviewed clinical data on 508 patients implanted monocularly with the inlay in the US IDE clinical trial. The FDA will consider the advisory panel outcome as part of its own determination of the benefit-risk of AcuFocus' Pre-Market Approval (PMA) submission for the KAMRA inlay.
Presbyopia is the age-related loss of near vision that occurs when the natural crystalline lens loses its ability to accommodate. Presbyopia currently impacts more than 100 million people in the United States. The KAMRA inlay is implanted into the patient’s non-dominant eye and uses the principle of small-aperture optics to improve near vision with minimal change in distance vision. Several KAMRA patients spoke before the panel about their reduced dependence on reading glasses and renewed ability to perform regular daily tasks -- reading, tying a fly-fishing lure, working on a computer, and driving -- with ease and without glasses. In addition, John Vukich, M.D., Jay Pepose, M.D., Vance Thompson, M.D., and Dan Durrie, M.D., spoke about their experience with the KAMRA inlay.
“The KAMRA inlay represents more than a decade of research, development and clinical evaluation and we appreciated the opportunity to present the KAMRA data to the Ophthalmic Devices Advisory Panel,” said Nick Tarantino, O.D., Chief Clinical and Regulatory Officer for AcuFocus. “We now look forward to continuing to work with the FDA on advancing the KAMRA inlay PMA submission.”
About Presbyopia
Presbyopia occurs as part of the normal aging process and 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
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. More than 20,000 KAMRA inlays have been implanted and it is available for sale in over 50 countries worldwide. The AcuFocus KAMRA inlay is a 2012 Medical Design Excellence Awards® Finalist. For more information about the KAMRA inlay from AcuFocus visit www.AcuFocus.com. KAMRA® is a trademark of AcuFocus, Inc.
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Allison Potter
Pascale Communications, LLC
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