The KAMRA™ inlay from Acufocus received FDA approval on April 17, 2015.
“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 approval was based on the results of 508 patients treated at 24 global investigational sites. 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.