ReVision Optics Eyes Panel Discussion in Q3

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.

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