ReVision Optics said today that 1-year results from the Phase III FDA clinical study of its Raindrop Near Vision Inlay designed for treating presbyopia indicated a 92% rate of satisfaction among study subjects. The outcomes data was published in the journal Ophthalmology this month.
The Raindrop is a microscopic hydrogel inlay for treating presbyopia, which the Lake Forest, Calif.-based company said could reduce or eliminate the need for reading glasses.
The inlay is placed in the cornea of the patient’s non-dominant eye during a 10-minute procedure to gently reshape the anterior curvature of the cornea to provide near and intermediate vision, ReVision said.
“These clinical outcomes clearly show that subjects in this trial who had difficulty with near visual acuity due to presbyopia have excellent uncorrected vision at all distances one year after treatment with the Raindrop Near Vision Inlay. It is an honor to have the Raindrop clinical outcomes published in the Academy’s journal,” CEO John Kilcoyne said in a press release
Data from the 1-year follow up indicated that average uncorrected near visual acuity improved by 5 lines on a standard eye chart in the treated eye, with 93% of the subjects achieving uncorrected near visual acuity of 20/25 in the treated eye.
The mean uncorrected visual acuity for both eyes exceeded 20/20 at all distances with no loss in contrast sensitivity, the company said.
“Key to these results is the high rate of patient satisfaction, which is an indication of the improved quality of life that the Raindrop could provide to the millions of people impaired by age-related loss of near vision,” Kilcoyne said in prepared remarks.
In November last year, Revision said the FDA accepted its premarket approval application for the Raindrop near vision inlay.
Last October, ReVision Optics said it submitted the final module of its premarket approval application for its Raindrop near vision inlay.
Data for the 4th and final module submitted came from more than 300 patients with 24 months of post-procedure monitoring. The data came from a multi-center clinical trial which evaluated the safety and effectiveness of the inlay under FDA investigational device exemption.