AcuFocus
AcuFocus, Inc., the global leader in corneal inlay technology announced today that the United States Food and Drug Administration has approved its groundbreaking product, the KAMRA inlay. The KAMRA inlay is indicated to improve near vision by extending depth of focus in presbyopic patients who have emmetropic refractions (+0.50 D to -0.75 D). This approval represents the first major advancement in the surgical correction of presbyopia in well over a decade.
Presbyopia is the age-related loss of near vision that affects virtually everyone over age 50. Researchers estimate that more than 114 million people in the United States, including the entire Baby Boomer generation, have presbyopia.1 This estimate is expected to grow to more than 123 million by 2020. Today, most people with presbyopia must rely on reading glasses to see objects up close.
“The KAMRA inlay is the number one implanted corneal inlay globally,” said Jim Mazzo, Chairman and CEO of AcuFocus, Inc. “After a decade of research, development and clinical investigation, we are delighted to bring this innovative technology to surgeons and patients in the U.S.”
The KAMRA inlay approval was based on the results of 508 patients treated at 24 investigational sites worldwide. Patients in the clinical study experienced an average improvement in uncorrected near visual acuity of 3.0 lines between their pre-op exam and the 12-month follow-up visit. This improvement was maintained over the 5-year duration of the study. Mean pre-operative uncorrected distance visual acuity in the inlay-implanted eye was maintained across all follow-up exams, unlike other presbyopia correcting procedures where distance vision is compromised in order to improve near vision.
“Near-vision loss from presbyopia can be a significant challenge in the everyday lives of patients, especially those who are emmetropic, which means they previously enjoyed normal vision without the need for glasses, contacts or other correction,” said Daniel S. Durrie, MD, founder of Durrie Vision, Overland Park, Kansas. “With the approval of the KAMRA inlay, we now have a reliable solution for presbyopes who want to enjoy many daily activities without reading glasses.”
The KAMRA inlay is an ultra-thin opaque ring that is implanted monocularly into the patient’s non-dominant eye. The device utilizes the principle of small aperture optics, or pinhole effect, to extend depth-of-focus for patients suffering from age-related near vision loss. The inlay measures 3.8 mm in total diameter and has a 1.6 mm central aperture. As a result of this novel design, central focused light is allowed to reach the retina uninterrupted resulting in functional vision from near to far without reading glasses.
“Surgical options for patients frustrated with near vision loss have previously been limited and often required patients to accept compromises like loss of effect over time,” said John Vukich, MD, Associate Clinical Professor at the University of Wisconsin-Madison Medical School, Madison, Wisconsin. “With the KAMRA inlay now available in the United States, we have a safe, effective and long-term solution for presbyopes that is designed especially for their needs.”
The company will host an educational event on the KAMRA inlay at the upcoming American Society of Cataract and Refractive Surgeons (ASCRS) annual meeting in a company sponsored Corporate Morning symposium on Saturday, April 18th beginning at 8:30am at the San Diego Convention Center, Room 8. Wet lab and product demonstrations will be available at the AcuFocus exhibit booth #317. More information about these events is available at www.acufocusevents.com.