Print 28 September 2015
LAKE FOREST, Calif. (September 28, 2015) – ReVision Optics, Inc. (RVO®), a leader in implantable presbyopia-correcting corneal inlay technology, announces the submission to the U.S. Food and Drug Administration (FDA) of the fourth and final module of the company’s Premarket Approval (PMA) application for the Raindrop® Near Vision Inlay. The Raindrop is a microscopic hydrogel inlay designed to correct presbyopia, thus reducing or even eliminating the need for reading glasses. The fourth module includes clinical data from more than 300 subjects who have been followed for at least 24 months post-procedure.
“Completion of the PMA submission is clearly our most significant milestone to date in advancing the Raindrop toward FDA approval and expanding our commercial footprint into the U.S. market,” said John Kilcoyne, RVO President and Chief Executive Officer. “The PMA submission consists of four modules, two of which have been accepted and closed by FDA. We anticipate FDA closing the third module (manufacturing) after it completes our on-site Good Manufacturing Practices inspection later this year, which would suggest a Raindrop approval in the second half of 2016.”
“The Raindrop provides a simple solution to the millions of Americans who require eyeglasses to perform everyday activities such as reading a computer screen or dialing a cell phone,” said Kilcoyne. “The Raindrop approach to correcting presbyopia involves placing an inlay in the non-dominant eye during a quick, ten-minute procedure. The Raindrop Inlay changes the anterior curvature of the cornea, allowing for a natural restoration of near vision. Because the Inlay is approximately 80% water, it is as transparent as a natural water droplet and does not restrict the amount of light reaching the retina. Clinical data reported to date shows the Raindrop Inlay produces the strong visual acuity and high patient satisfaction that lead to what we call the WOW factor.”
The prospective, multicenter clinical trial evaluated the safety and effectiveness of the Raindrop Near Vision Inlay in improving near and intermediate vision in subjects with presbyopia under an Investigational Device Exemption (IDE). In July 2013, RVO announced that the subjects required for trial completion had been enrolled and had undergone the Raindrop procedure. The trial endpoints require that 75% of subjects achieve uncorrected near vision acuity of 20/40 or better in the treated eye at 24 months post-procedure, as well as the IDE safety parameters.
Presbyopia is considered to be a natural part of the aging process and is believed to be caused by the gradual loss of elasticity of the eye’s lens, which decreases the ability to focus up close. The first symptoms usually occur between the ages of 40 and 50.
ReVision Optics focuses on the development and commercialization of innovative optical solutions dedicated to presbyopic vision correction. RVO’s Raindrop Near Vision Inlay offers a unique, patented refractive surgery solution. The inlay is designed to improve near vision that has been lost by the eye’s natural aging process called presbyopia. The Raindrop Inlay provides an ideally suited surgical option for near and intermediate vision enhancement. The Raindrop is covered by approximately 50 issued patents around the world and has CE Mark approval.
CAUTION: Investigational device. Limited by U.S. (Federal) law to investigational use.
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