LAKE FOREST, Calif.--(BUSINESS WIRE)--ReVision Optics, Inc., a leader in implantable presbyopia-correcting corneal inlay technology, announces receipt of U.S. Food and Drug Administration (FDA) approval for the Raindrop® Near Vision Inlay, a novel corneal inlay for the surgical correction of presbyopia. The Raindrop Near Vision Inlay is indicated to improve near vision by reshaping the anterior curvature of the cornea in presbyopic patients who have emmetropic refractions (+1.00 D to -0.50 D).
Results from the study submitted to the FDA in ReVision Optics’ Premarket Approval (PMA) application showed clinically significant improvement in near visual performance, including:
- Average uncorrected near visual acuity improved by 5 lines on a standard eye chart (at 40 cm) in the treated eye. There was no loss in binocular distance vision.
- 98% of patients achieved uncorrected near visual acuity (UCNVA) of 20/40 or better and 88% of patients achieved UCNVA of 20/25 or better at 24 months in the treated eye.
- The mean uncorrected visual acuity for both eyes exceeded 20/20 at all distances; near, intermediate, and distance.
“The outstanding clinical results that supported FDA approval of the Raindrop Near Vision Inlay clearly show that patients who have difficulty with near vision due to presbyopia now have a new option to obtain excellent uncorrected vision at all distances,” said John Kilcoyne, ReVision Optics President and Chief Executive Officer. “We anticipate commercializing Raindrop in the U.S. to the approximate 2,800 surgeons and 30 million potential patients through a direct field salesforce beginning in the third quarter of 2016.
“We were very impressed by the effort and commitment of the FDA during the PMA approval process, as the Agency met or exceeded every milestone during the interactive review of the Raindrop PMA,” he added. “ReVision Optics is also grateful for the leadership and support of Drs. Roger Steinert and Douglas Koch, the medical monitors of the clinical study, and to the dedicated investigators, their clinical coordinators and staff who contributed their time, talents and expertise throughout the six-year study.”
The Raindrop Near Vision Inlay approval was based on the results of 373 patients treated at 11 investigational sites in the U.S. Patients in the clinical study experienced an average improvement in near vision of 5.0 lines between their preoperative examination and the 24-month post-operative follow-up visit. Although not an endpoint of the clinical study, patients also experienced an average improvement in intermediate vision of 2.5 lines between their preoperative examination and the 24-month post-operative follow-up visit. These improvements were maintained throughout all study follow-up periods and were included in the PMA. There was no change in distance vision binocularly, but patients did experience an average loss of 1.2 lines in distance vision in the treated eye. FDA considers a change of ≥2 lines to be clinically significant.
Information provided in the PMA submission confirmed that the Raindrop Near Vision Inlay is removable and that patients return to their baseline (preoperative) visual acuities if the device is removed. For the Raindrop Near Vision Inlay, refractive stability was achieved at 6 months unlike other presbyopic corneal inlays that may take up to 18 months, or longer, to achieve refractive stability.
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.