LAKE FOREST, Calif.--(BUSINESS WIRE)--ReVision Optics, Inc., a leader in implantable presbyopia-correcting corneal inlay technology, announces that clinical data from its Raindrop® Near Vision Inlay for the treatment of presbyopia was the subject of two presentations at the 2015 OIS@AAO conference, held last month in Las Vegas.
At the conference, John Kilcoyne, ReVision Optics President and Chief Executive Officer, presented an overview of clinical data from 344 patients followed for 24 months post-treatment with the Raindrop. The data included a comparison of uncorrected visual acuity at 24 months post-treatment versus pre-treatment, in the treated eye as follows:
- 88% of post-treatment patients had near visual acuity of ≥20/25 in the treated eye; none of the patients had preoperative near visual acuity of ≥20/25.
- 76% of post-treatment patients had intermediate visual acuity of ≥20/25 in the treated eye, compared with ≤18% of preoperative patients.
- All post-treatment patients had binocular distance visual acuity of ≥20/25.
“We are clearly seeing outstanding visual results with the Raindrop inlay, with excellent near, intermediate and distance function. This improved vision has resulted in very high satisfaction rates with 87% of patients reporting that they were satisfied at two years post treatment,” said Kilcoyne. “As previously announced, we have received notice from the FDA that our PMA submission is fileable and we are having productive interactions with the Agency. We believe that this puts us on track for an advisory committee meeting in the second quarter of 2016 and an approval in late 2016.” A webcast of Mr. Kilcoyne’s presentation is available at http://ois.net/revision-optics-aao2015/.
In a second presentation, Douglas D. Koch, M.D., Professor and Allen, Mosbacher, and Law Chair of the Ophthalmology Department at Baylor College of Medicine in Houston, discussed three-month follow-up data from 188 Raindrop patients with preoperative refraction between -0.5 D to +1.5 D. In his presentation, entitled “Profocal Cornea Created by Transparent Hydrogel Corneal Inlay: Mechanism of Action and Clinical Implications,” Dr. Koch discussed the ability of the Raindrop to improve near-vision by reshaping the profile of the cornea. Study patients showed good near vision at three months post-treatment with a mean of 20/25 and an average gain of four lines in near visual acuity, with only a slight loss in distance vision in the treated eye. Distance and near binocular task performance improved equally across all groups in both good and dim light. The study results were published in the August 2015 issue of Journal of Cataract Refractive Surgery.
“We were delighted to showcase our Raindrop clinical data at this conference, which focused on innovation in ophthalmology and was attended by more than 900 physicians, industry executives and investors,” added Kilcoyne.
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 transparent and therefore does not restrict the amount of light reaching the retina. The reshaping of the anterior curvature of the cornea 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. The Inlay is designed to improve near vision that has been lost through the eye’s natural aging process called presbyopia. The Raindrop Inlay provides an ideally suited surgical option for near and intermediate vision enhancement. The Raindrop Inlay has received CE Mark approval.
CAUTION: Investigational device. Limited by Federal (United States) law to investigational use.