ReVision Optics said Monday it submitted the final module of its premarket approval application for its Raindrop near vision inlay.
The Raindrop is a microscopic hydrogel inlay for treating presbyopia, which the Lake Forest, Calif.-based company said could reduce or eliminate the need for reading glasses. Data for the 4th and final module submitted came from more than 300 patients with 24 months of post-procedure monitoring.
“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. The PMA submission consists of 4 modules, 2 of which have been accepted and closed by FDA. We anticipate FDA closing the 3rd 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,” CEO John Kilcoyne said in a press release.
The data came from a multi-center clinical trial which evaluated the safety and effectiveness of the inlay under FDA investigational device exemption.
Endpoints for the trial are an improvement of visual acuity to 20/40 or better at 24 months post-procedure in 75% of the patients, as well as IDE safety parameters, the company said.
“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. 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,” Kilcoyne said in prepared remarks.