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BLOG: Approval of intracorneal inlays is good for everyone
In a nearly split decision by the FDA Ophthalmic Devices Panel on Friday, June 6, the Acufocus Kamra inlay was recommended for approval. This inlay, made of an opaque, fenestrated polyvinylidene, uses small aperture optics (pinhole effect) to assist near vision in implanted patients.The Kamra inlay, which is implanted in one eye, met its primary endpoint of achieving uncorrected near acuity of 20/40 or better in nearly 85% of eyes at 12 months. Similar results have been seen with other inlays, such as the ReVision Optics Raindrop and Presbia’s Flexivue (Read more...)