Print 01 August 2016
Findings Published in ARVO Journal IOVS
LAKE FOREST, Calif.--(BUSINESS WIRE)-- ReVision Optics, Inc., a leader in implantable presbyopia-correcting corneal inlay technology, announces clinical results indicating that structural changes induced by the corneal shape-changing Raindrop Near Vision Inlay leads to significantly improved near and intermediate vision in subjects with presbyopia, with no loss of distance binocular acuity. The [Company-sponsored] study was published in a special issue of the peer-reviewed ARVO journal Investigative Ophthalmology and Visual Science (IOVS) (Invest. Ophthalmol. Vis. Sci. 2016; 57(9):OCT154-OCT161. doi: 10.1167/iovs.15-18858) and is available at http://www.ncbi.nlm.nih.gov/pubmed/27409467.
The Raindrop Near Vision Inlay is a microscopic hydrogel corneal inlay placed in the non-dominant eye to correct presbyopia. It received U.S. Food and Drug Administration (FDA) approval on June 29, 2016 and ReVision Optics expects to begin U.S. commercial activity in the third quarter of this year.
The study, “Structural Changes Induced by a Corneal Shape-Changing Inlay, Deduced from Optical Coherence Tomography and Wavefront Measurements” (Lang, et al), is based on an analysis of 30 presbyopic subjects enrolled in a prospective clinical investigation of the Raindrop Near Vision Inlay. Changes to the eye’s connective tissue framework, known as the stroma, were calculated at one-year post-procedure by measuring the anterior corneal surface using wavefront techniques and the thinning of the epithelium (the thin layer of surface cells coating the cornea) using tomography. Study results indicate that the stroma predominately takes on the curvature shape of the inlay.
“This newly published study shows that changes in the eye’s structure were greatest in regions where the Raindrop Near Vision Inlay induces the most pronounced changes to the surface curvature, thus leading to the outstanding improvement in near and intermediate visual acuity which we have repeatedly demonstrated in our clinical trials,” said John Kilcoyne, ReVision Optics President and Chief Executive Officer. “This study further showed no adverse corneal conditions associated with epithelial thinning that can occur with other refractive procedures or corneal pathologies. We extend thanks to the clinicians who participated in this study for elucidating these important insights regarding the mechanism of epithelial remodeling with the Raindrop Near Vision Inlay.”
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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