Favorable clinical results build support for treatment with the Raindrop
LAKE FOREST, Calif.--(BUSINESS WIRE)-- ReVision Optics®, Inc. (RVO), a leader in implantable inlay technology to treat presbyopia, announced that favorable results from clinical studies with its proprietary, patented Raindrop™ Near Vision Inlay (formerly the Vue+® and PresbyLens®) were featured in two presentations at the prestigious ESCRS 2012 (XXX Congress of the European Society of Cataract and Refractive Surgeons Conference) held in Milan, Italy.
The presentations were as follows:
“The EuroKLEAR trial: Early results using an aspheric corneal inlay to improve near and intermediate vision in emmetropic presbyopes” was presented by Béatrice Cochener, M.D., Professor of Ophthalmology and Head of the Eye Clinic at the University of Brest, France, Vice President of the French Implant and Refractive Surgery Association, and President of the Société Française d'Ophtalmologie. Dr. Cochener reviewed the Raindrop technology and EuroKLEAR study design, and presented data from 27 patients who participated in the EuroKLEAR and predecessor studies. Near vision for 75% of these patients was J2 (20/32) or better on first day following treatment. By one week post-treatment, near vision capability was stable and 90% of patients were J1 (20/25) or better. The study showed little change in patients’ visual symptoms from pre-treatment to 12 months post-treatment.
|“Subjects in these studies had stable vision at six months and beyond, and overall showed improvement in near and intermediate visual acuity with binocular vision that remained very good,” said Dr. Cochener. “These clinical results combined with other past study data provide clear support for the use of the Raindrop as a viable surgical option in treating presbyopia.”|
|“Vue+ corneal inlay results” was presented by Vinod Gupta, MBBS, DO, FRCOphth, Consultant Ophthalmologist Ultralase Clinics, United Kingdom. One- to six-month follow-up data from 45 subjects implanted with the Raindrop Near Vision Inlay by three surgeons showed all subjects able to read 10 point type face commonly found in novels, magazines, and instructions. A patient satisfaction rate of 96% was reported in this commercial setting.|
“These favorable clinical results with our Raindrop were presented by leaders in the field of presbyopia at arguably the most important annual ophthalmic conference held outside the United States,” said John T. Kilcoyne, RVO President and Chief Executive Officer. “We are building a growing body of clinical evidence verifying improvements in near and intermediate vision with the Raindrop, as well as exceptionally high levels of satisfaction. By sharing these results at the ESCRS, we have gained greater awareness of and acceptance for the Raindrop with ophthalmologists from around the world.”
Raindrop Near Vision Inlay
The Raindrop Near Vision Inlay has received CE Mark authorization and is available in the European Union, and is currently in a Phase III clinical trial in the United States. The Raindrop Near Vision Inlay is comprised of approximately 80% water. During a 10-minute procedure, the inlay is placed just beneath the surface of the eye. The Raindrop is as transparent as natural tears and is less than half the thickness of a human hair. The 2 mm diameter by 30 µm thick inlay resembles a water droplet and adds no power nor restricts the amount of light reaching the retina. It is simply designed to gently reshape the anterior curvature of the cornea providing for a more natural restoration of near and intermediate vision.
About ReVision Optics
ReVision Optics, Inc. focuses on the development and commercialization of custom optical solutions dedicated to presbyopic vision correction. RVO’s Raindrop™ Near Vision Inlay (formerly the Vue+® and PresbyLens®) offers a unique, patented refractive surgery solution. The inlay is designed to improve near vision that has been lost by the eye’s natural aging process called presbyopia. The Raindrop inlay provides an ideally suited surgical option for near and intermediate vision enhancement.
The Company is actively pursuing regulatory approvals and market opportunities for the Raindrop Near Vision Inlay worldwide. The Raindrop has received CE Mark authorization and is available for sale in Europe.
CAUTION: Investigational device. Limited by U.S. (Federal) law to investigational use.
Source: ReVision Optics, Inc.