Print 06 October 2015
ReVision Optics announced the submission to the FDA of the fourth and final module of the company’s premarket approval (PMA) application for the Raindrop near vision inlay, according to a company news release. 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 US market,” John Kilcoyne, RVO President and Chief Executive Officer, said in the news release. “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,” Mr. Kilcoyne added. “The Raindrop approach to correcting presbyopia involves placing an inlay in the non-dominant eye during a quick, 10-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.”
Raindrop Inlay Clinical Trial
The prospective, multicenter clinical trial evaluated the safety and effectiveness of theRaindrop 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.
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