FDA panel recommends approval of Kamra with some reservations

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 to recommend approval of the Kamra inlay.The Kamra inlay is indicated for the improvement of near and intermediate vision in presbyopic patients. The inlay is placed intrastromally in the cornea on the visual axis through a femtosecond laser-created pocket using a spot/line separation of 6 x 6 µ or less. The inlay should be placed at a depth equal to or greater than 180 µ.

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