AcuFocus, Inc. Gets Mixed FDA Panel Review For Presbyopia Device
Published: Jun 09, 2014
The FDA's Ophthalmic Devices Panel issues a mixed vote on the efficacy of AcuFocus's Kamra intraocular implant in improving near-vision in patients with presbyopia. A panel of FDA experts today was divided on whether the federal watchdog agency should approve the AcuFocus Kamra Inlay, a 1st-of-a-kind permanent corneal implant for the improvement of near and intermediate vision in patients with presbyopia, a form of age-related far-sightedness. Of the 8 panelists 7 voted that Kamra is effective, the panel was evenly split on the question of safety, with the chairman breaking the tie and voting against.
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