Print 31 August 2016
LAKE FOREST, Calif.--(BUSINESS WIRE)--ReVision Optics, Inc., a leader in implantable presbyopia-correcting corneal inlay technology, announces the U.S. commercial launch of the Raindrop® Near Vision Inlay. 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. “All of these surgeons are driving forces behind commercialization of the Raindrop Near Vision Inlay, having served as investigators in our clinical study.”
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.
“It is highly gratifying to successfully perform the first U.S. commercial case with the Raindrop Near Vision Inlay,” said Dr. Slade. “Over the years in my practice I’ve continually heard from patients with presbyopia looking for an alternative to reading glasses. The Raindrop Near Vision Inlay provides that solution and brings what we call the ‘WOW’ factor to these patients with quickly enhanced near and intermediate vision, without impairing binocular distance vision.”
“I’m excited that this elegant solution for presbyopia is now available in the U.S.,” said Dr. Parkhurst. “Most patients see better immediately following the procedure, and the inlay is as transparent as a tear drop. The Raindrop Near Vision Inlay works well in both bright and dim light, and although we are confident in the clinical outcome, the inlay is removable with patients returning to their preoperative best-corrected vision following removal. Patient satisfaction with any corrective procedure is a critical consideration, and a recently published study reported an exceptionally high patient satisfaction rate of 92% one year following the procedure.”
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. 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.
About ReVision Optics
ReVision Optics, Inc. focuses on the development and commercialization of innovative optical solutions dedicated to presbyopic vision correction. The company’s Raindrop Near Vision Inlay offers a unique, patented refractive surgery solution. The Raindrop improves near vision that has been lost through the eye’s natural aging process called presbyopia. The Raindrop Near Vision Inlay provides an ideally suited surgical option for near-vision enhancement.
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