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FDA Approves Raindrop® Near Vision Inlay

FDA Approves Raindrop® Near Vision Inlay

Created on: Thursday, July 21, 2016
Author: Coastal Vision Medical Group

ReVision Optics, Inc., a leader in implantable presbyopia-correcting corneal inlay technology, announces receipt of U.S. Food and Drug Administration (FDA) approval for the Raindrop® Near Vision Inlay, a novel corneal inlay for the surgical correction of presbyopia. The Raindrop Near Vision Inlay is indicated to improve near vision by reshaping the anterior curvature of the cornea in presbyopic patients who have emmetropic refractions (+1.00 D to -0.50 D).

Results from the study submitted to the FDA in showed clinically significant improvement in near visual performance, including:

  • Average uncorrected near visual acuity improved by 5 lines on a standard eye chart (at 40 cm) in the treated eye. There was no loss in binocular distance vision.
  • 98% of patients achieved uncorrected near visual acuity (UCNVA) of 20/40 or better and 88% of patients achieved UCNVA of 20/25 or better at 24 months in the treated eye.
  • The mean uncorrected visual acuity for both eyes exceeded 20/20 at all distances; near, intermediate, and distance.

"The outstanding clinical results that supported FDA approval of the Raindrop Near Vision Inlay clearly show that patients who have difficulty with near vision due to presbyopia now have a new option to obtain excellent uncorrected vision at all distances," said John Kilcoyne, ReVision Optics President and Chief Executive Officer.

The Raindrop Near Vision Inlay approval was based on the results of 373 patients treated at 11 investigational sites in the U.S. Dr. Dan B. Tran, with Coastal Vision, participated in the study. Patients in the clinical study experienced an average improvement in near vision of 5.0 lines between their preoperative examination and the 24-month post-operative follow-up visit.

Information provided in the PMA submission confirmed that the Raindrop Near Vision Inlay is removable and that patients return to their baseline (preoperative) visual acuities if the device is removed. For the Raindrop Near Vision Inlay, refractive stability was achieved at 6 months unlike other presbyopic corneal inlays that may take up to 18 months, or longer, to achieve refractive stability.

View source version on businesswire.com


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