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Approval of intracorneal inlays is good for everyone
In a nearly split decision by the U.S. Food and Drug Administration’s 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 — the 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 inlay, both also undergoing clinical trials prior to approval.
For three reasons, corneal inlays are a great, new modality of vision correction that will undoubtedly bring excitement back to keratorefractive surgery.
- Inlays address a market that has been woefully underserved by the existing technologies of monovision LASIK and presbyopia-correcting lenses. Although these modalities have their strengths, they are simply not appropriate for many emmetropic presbyopes before cataracts develop.
- Inlays won’t interfere with future cataract surgery. Whether small-aperture like the Acufocus or multifocal like the other developing technologies, a corneal inlay could be coupled with a monofocal or toric lens implant in the future, giving the patient satisfactory distance and near.
- Inlays work. In studies of patient-reported outcomes, satisfaction with all these products is in the 95%+ range. This rivals LASIK among young patients and is a benchmark we have still yet to reach with any IOL technology.
I am excited about the FDA panel’s vote and eagerly look forward to approval of the Kamra inlay.