AcuFocus receives KFDA approval for KAMRA inlay to treat presbyopia

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.