LAKE FOREST, Calif.--(BUSINESS WIRE)--ReVision Optics®, Inc. (RVO), the leader in implantable inlay technology to treat presbyopia, has received conditional approval from the U.S. Food and Drug Administration (FDA) to continue and complete enrollment in its Phase III clinical trial with its Raindrop™ Near Vision Inlay (formerly the PresbyLens®). The prospective, multicenter Phase III clinical trial is evaluating the safety and effectiveness of the patented, proprietary Raindrop Near Vision Inlay in improving near vision in subjects with presbyopia under an Investigational Device Exemption (IDE).
In early January 2013, RVO submitted six-month follow-up data to the FDA from 75 of 100 subjects enrolled in the first portion of the Phase III clinical trial. Highlights of the submitted data include:
- 100% of subjects had an uncorrected near visual acuity of 20/25 (J1) or better in the treated eye. All subjects (100%) achieved 20/25 (J1) or better when tested bilaterally.
- 97% of subjects had an uncorrected intermediate visual acuity of 20/32 or better in the treated eye. 99% of subjects achieved 20/32 or better when tested bilaterally
- 96% of subjects had an uncorrected distance visual acuity of 20/40 or better in the treated eye. All subjects (100%) achieved 20/20 or better when tested bilaterally.
- 91% of subjects gained 4 lines or more of uncorrected near visual acuity in the treated eye as measured on a standard eye chart
- None of the subjects had a loss of ≥2 lines best corrected distance vision compared to their pre-operative measurements
- 94% of subjects were satisfied with the correction they received following the Raindrop inlay implant
“These data are clearly very impressive and we are particularly gratified by the high rate of satisfaction with the Raindrop,” said John T. Kilcoyne, RVO President and Chief Executive Officer. “We also are extremely pleased with the FDA’s timely review of the submitted data. We expect enrollment to be completed during the third quarter of this year.”
In addition to ReVision Optics’ success in its efforts to complete Phase III of its U.S. IDE, the company recently initiated a controlled commercial launch of the Raindrop Near Vision Inlay in both Europe and Asia.
About the Raindrop Near Vision Inlay
The Raindrop Near Vision Inlay is designed to reduce or even eliminate the need for reading glasses. The Raindrop Near Vision Inlay is placed just beneath the surface of the non-dominant eye during a 10-minute procedure. It is comprised of approximately 80% water and therefore has a refractive index very similar to the cornea. The inlay gently produces a smooth variation in focal power across the pupil by microscopically altering the surface shape of the cornea. It is as transparent as natural tears, therefore not restricting the amount of light reaching the retina. The gentle reshaping of the anterior curvature of the cornea provides for a natural restoration of near and intermediate vision.
Presbyopia is considered to be a natural part of the aging process and is believed to be caused by the gradual loss of elasticity of the eye’s lens, which decreases the ability to focus up close. The first symptoms usually occur between the ages of 40 and 50.
Participation in Raindrop Near Vision Inlay Clinical Trial
The Phase III Raindrop Near Vision Inlay clinical trial is being conducted at a number of specialized ophthalmology centers across the U.S. Subjects interested in participating in the IDE trial and to be referred to a participating treatment center are requested to complete a pre-screening questionnaire available on the ReVision Optics website at http://www.nearvisiontrial.com/pages/Do_You_Qualify.htm.
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.