Print 10 November 2015
Marks Important Milestone in U.S. Market Approval Process
LAKE FOREST, Calif.--(BUSINESS WIRE)--ReVision Optics, Inc. (RVO®), a leader in implantable presbyopia-correcting corneal inlay technology, announces that the U.S. Food and Drug Administration (FDA) has accepted and deemed fileable the company’s premarket approval (PMA) submission for the Raindrop® Near Vision Inlay. The Raindrop is a microscopic hydrogel inlay designed to correct presbyopia, thus reducing or eliminating the need for reading glasses. Acceptance and filing of the submission means the FDA has made a threshold determination that the Raindrop PMA submission is sufficiently complete to move forward in the FDA review and approval process.
The date that the FDA deems a PMA submission fileable marks the initiation of a 180-day period, during which the Agency conducts an in-depth scientific, regulatory and quality system review of the submission. During the review period, ReVision Optics will work with the FDA to answer any questions and fulfill any requests related to the submission. Based on the timing of obtaining FDA fileability status, ReVision Optics expects the “Day 100 Meeting” with the FDA to occur in the first quarter of 2016. At that time, the FDA will determine the need for an advisory “panel” committee meeting before moving forward with its decision regarding U.S. marketing approval.
“The FDA’s determination of fileability marks an important advancement in the Agency’s process, John Kilcoyne, RVO President and Chief Executive Officer, “based on our regulatory process to date, we are optimistic about reaching our goal of FDA approval for Raindrop in 2016.”
About the Raindrop Near Vision Inlay
The Raindrop Near Vision Inlay is placed in the cornea of the non-dominant eye during a 10-minute procedure. It is comprised of approximately 80% water and has a refractive index very similar to the cornea. It is as transparent as natural tears, therefore not restricting the amount of light reaching the retina. The gentle reshaping of the anterior curvature of the cornea by the Raindrop Near Vision Inlay is designed to provide near and intermediate vision.
About ReVision Optics
ReVision Optics, Inc. 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 to improve near and intermediate vision in patients who have presbyopia, the loss of near vision due to the eye’s natural aging process. The Raindrop Inlay has received CE Mark approval.
CAUTION: Investigational device. Limited by U.S. (Federal) law to investigational use.
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