First corneal inlay for presbyopia treatment submitted to FDA
IRVINE, Calif. - Tuesday, March 19th 2013 [ME NewsWire]
(BUSINESS WIRE)-- AcuFocus (www.AcuFocus.com) has submitted the final module of their premarket approval application (PMA) for the KAMRA™ corneal inlay to the US Food and Drug Administration (FDA).
Over time, everyone will experience loss of reading vision and blurriness, or presbyopia, as they age. The KAMRA™ corneal inlay is designed to revive reading vision by allowing only focused light to enter the eye. Patients who have undergone this procedure may regain the vision that they had prior to the presbyopia, are once again performing daily tasks such as reading text messages, checking the time on a wristwatch, reading store shelf prices, working on a computer and driving with ease without glasses.
Ed Peterson, CEO and President of AcuFocus states, "After 10 years of development and thousands of patients treated globally, it is incredible to finally be able to submit this last module to the FDA for US approval.”
John Vukich, MD, an investigator in the US clinical trials, comments, "Patients, practitioners and the ophthalmic industry have all been in search of a reliable corneal solution for presbyopia and I believe the KAMRA inlay is that solution.”
As a novel technology with no similar precedent in the market, the KAMRA™ inlay has undergone rigorous approval processes in several countries. The inlay is now approved in 47 countries across Europe, Asia-Pacific, Middle East, and the Americas, with most recent approvals in Canada. To date, nearly 20,000 KAMRA inlays have been implanted worldwide and over 150 surgeons have been certified to offer KAMRA Vision™ to their patients.
"This is the first corneal inlay for treatment of presbyopia submitted for US approval,” states Corina van de Pol, OD, PhD, and Chief Clinical Officer at AcuFocus. "And, we look forward to working with the FDA throughout the review process.”
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.
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 47 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.
Pascale Communications, LLC
Allison Potter, 619-550-1867