FDA panel affirms Kamra inlay’s efficacy and benefits, votes “no” on safety

GAITHERSBURG, Md. — Amid concerns about safety and study methodology, the U.S. Food and Drug Administration’s Ophthalmic Devices Panel of the Medical Devices Advisory Committee voted June 6 on three questions concerning the Kamra inlay. Although more panel members voted “no” on a question of the device’s safety, a majority voted “yes” on efficacy and a slim majority voted “yes” on whether the device’s benefits outweigh the risks. The Kamra inlay (AcuFocus) is indicated for the improvement of near and intermediate vision in presbyopic patients. The inlay is placed intrastromally (Read more...)

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