FDA
9th June 2014

FDA Panel Narrowly Recommends Approval of KAMRA Inlay

During this meeting, the Ophthalmic Devices Panel of the Medical Devices Advisory Committee discussed information related to the premarket approval application for the KAMRA Inlay (Model ACI 7000) (KAMRA Inlay) submitted by applicant AcuFocus, Inc.  The KAMRA Inlay is a permanent corneal implant that is placed intrastromally in a corneal pocket or under a corneal flap. 

FDA Panel Narrowly Recommends Approval of KAMRA Inlay

During this meeting, the Ophthalmic Devices Panel of the Medical Devices Advisory Committee discussed information related to the premarket approval application for the KAMRA Inlay (Model ACI 7000) (KAMRA Inlay) submitted by applicant AcuFocus, Inc.  The KAMRA Inlay is a permanent corneal implant that is placed intrastromally in a corneal pocket or under a corneal flap.  The opaque annulus of the inlay reduces the aperture of the eye, which improves near vision by providing an increased depth of focus in the implanted eye.  The proposed indication for use states that the KAMRA Inlay is indicated for the improvement of near and intermediate vision in presbyopic patients who require near or intermediate correction.  The KAMRA Inlay is intended to be placed intrastromally in the cornea, on the visual axis, by way of a femtosecond laser-created pocket using a spot/line separation of 6×6 microns (µ) or less.  The KAMRA Inlay should be placed at a depth equal to or greater than 180 µ.

During this meeting, there were several discussion questions and three primary voting questions. For the question regarding whether the implant was safe in patients meeting the criteria specified in the proposed indication, four panelists voted yes and five voted no.

Regarding whether the implant was effective in patients meeting the proposed indication’s criteria, seven panelists voted yes and one voted no.

Lastly, four panelists voted yes, three voted no, and one abstained when they were asked whether the benefits outweigh the risks when using the device as indicated.

Panelists expressed some reservations about approval, particularly about missing data and methodologies used during the study of the device. Janine A. Clayton, MD, a temporary voting member for the Ophthalmic Devices Panel, noted that despite her concerns, she still felt there was adequate evidence to support a yes vote for each of the voting questions presented.

In 2005, the KAMRA Inlay medical device received CE Mark approval in the European Union.

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