JUN 11, 2014
The U.S. Food and Drug Administration’s ophthalmic devices advisory panel has determined that the benefits of AcuFocus’ Kamra inlay outweigh the risks for presbyopic patients.
Of the eight panelists, seven voted that the Kamra is effective, but the panel was evenly split on the question of safety, with the chairman breaking the tie and voting against it. The panel was also divided on the question of whether the benefits outweigh the risks, with four voting yes, three no, and one abstaining.
The vote was cast after the panel reviewed clinical data on 508 patients with the inlay implanted monocularly in the U.S. Investigational Device Exemption clinical trial.
Several inlay patients spoke before the panel about their reduced dependence on reading glasses and renewed ability to perform regular daily tasks.
The inlay is indicated for the improvement of near and intermediate vision in presbyopic patients and is placed intrastromally through a femtosecond laser-created pocket. It’s been approved in 50 countries in Europe, Asia-Pacific, the Middle East and the Americas and an estimated 20,000 have been implanted.