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).
“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.”
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."
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