The Raindrop Near Vision Inlay for the treatment of presbyopia boasts a 2-mm diameter, 80% water composition, the same refractive index as the natural cornea, and is removable, said ReVision Optics’ president and CEO John Kilcoyne.
“This is profocal shape-changing technology,” he said. “The Raindrop changes the anterior curvature of cornea to improve near and intermediate vision.”
From a regulatory standpoint, modules 1 and 2 are now closed, and modules 3 and 4 have been submitted to the FDA. The company anticipates an ophthalmic panel discussion some time during the third quarter, and expects an approval decision by fourth-quarter 2016.
One-year clinical results have been published in Ophthalmology, and showed 93% of the 293 implanted eyes achieved 20/25 or better uncorrected near vision (a gain of more than 5 lines), 97% achieved 20/32 or better uncorrected intermediate vision (a gain of 2.5 lines), and 95% of eyes achieved 20/40 or better uncorrected distance vision.
“We had a 92% patient satisfaction rate,” he said.
From a financial perspective, the private-pay aspect of the inlay limits the potential to those with a household income of more than $75,000, Kilcoyne said; the potential Raindrop market could be just over 13 million presbyopic emmetropes and 3.6 million presbyopic low hyperopes.
“We have a sweet spot,” he said, adding those numbers only reflect the US market. US-based focus groups and an online survey showed people believe presbyopia correction is a quality-of-life issue rather than a functional disorder, and that inlays are “friendlier” than implants.
Almost two-thirds of the respondents were likely to ask about the inlay, and 71% would seek out an ophthalmologist if the technology were available.
John T. Kilcoyne
John T. Kilcoyne brings more than 29 years of experience in the medical device market to RVO. He has a demonstrated record in understanding the needs of both patients and physicians combined with an ability to move companies from development into the commercial market.