The initial launch plan calls for the company’s direct field force to focus on sites that participated in the U.S. IDE clinical trial, followed by a more broad-based expansion later in 2016.
“We are excited to kick-off our U.S. launch with procedures performed by an outstanding group of ophthalmologists including Drs. Stephen Slade, Jeffery Whitman, Greg Parkhurst, and Ralph Chu who treated patients on Tuesday, August 30th in Houston and San Antonio, Texas, and in Bloomington, Minnesota,” said John Kilcoyne, ReVision Optics President and Chief Executive Officer.
The Raindrop Near Vision Inlay is a novel corneal inlay for the surgical correction of presbyopia, which is a natural part of the aging process that decreases the ability of the eye to focus on near objects.
The Raindrop is a clear, biocompatible inlay that is placed in the non-dominant eye in a 10-minute outpatient procedure. It is about the size of a pinhead and is less than half the thickness of a human hair. It mimics the natural cornea by changing the central curvature of the eye to improve near vision.
The Raindrop Near Vision Inlay is placed in the cornea of the non-dominant eye during a 10-minute procedure.
The Raindrop is comprised of approximately 80% water and has a refractive index very similar to the cornea. It is transparent and therefore does not restrict the amount of light reaching the retina. The reshaping of the anterior curvature of the cornea improves near vision.
The Raindrop Near Vision Inlay has received approval by the U.S. Food and Drug Administration, authorization to affix the CE Mark for the European Union, license approval by the Ministry of Food and Drug Safety (South Korea), approval by the Therapeutic Goods Administration (Australia) and registration with the Medicines and Medical Safety Authority (New Zealand). Other country-specific registrations are pending.
