ReVision Optics said today the FDA accepted its premarket approval application for the 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.
The inlay is placed in the cornea of the patient’s non-dominant eye during a 10-minute procedure to gently reshape the anterior curvature of the cornea to provide near and intermediate vision, ReVision said.
“The FDA’s determination of fileability marks an important advancement in the Agency’s process, based on our regulatory process to date, we are optimistic about reaching our goal of FDA approval for Raindrop in 2016,” CEO John Kilcoyne said in a press release.
Last month, ReVision Optics said it submitted the final module of its premarket approval application for its Raindrop near vision inlay.
Data for the 4th and final module submitted came from more than 300 patients with 24 months of post-procedure monitoring. The data came from a multi-center clinical trial which evaluated the safety and effectiveness of the inlay under FDA investigational device exemption.