The KAMRA™ Inlay Receives FDA Approval

This month, the United States Food and Drug Administration has approved the groundbreaking treatment by AcuFocus, the KAMRA inlay. This represents the first major advancement in the surgical correction of presbyopia in well over a decade.

The KAMRA inlay improves near vision by extending depth of focus in presbyopic patients who have emmetropic refractions (+0.50 D to #0.75 D). Presbyopia is the age related loss of near vision that affects virtually everyone over the age of 50. Currently, many people rely on reading glasses to see objects up close.

“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.” said Jim Mazzo, Chairman and CEO of AcuFocus, Inc.

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. Meanwhile, 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.

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. 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.

Read more about the KAMRA Inlay available at LaserVision’s Guildford hospital.

About AcuFocus
AcuFocus Inc. is a privately held ophthalmic medical device company that develops and markets breakthrough technologies for the improvement of near vision. For more information, visit www.AcuFocus.com.