The presbyopia market is estimated to comprise more than 2 billion people by 2020. ReVision Optics has developed the Raindrop Near Vision inlay to address that market, with a potential of 30 million eligible patients. The Raindrop itself is a 2-mm diameter hydrogel inlay, 30 microns thick. It’s 80% water. It’s clear, so it enables maximum light transmission. The inlay is placed in one eye under a femtosecond laser flap, and once there changes the curvature of the cornea. Within the first 24 hours after implantation, the epithelial layer remodels to create a smooth focal gradient. The company has designed the inlay for multiple situations: mild hyperopia, post-LASIK, emmetropic, pseudophakic, and myopia.
The U.S. IDE study on emmetropes evaluated near, intermediate, and distance vision and followed patients for 24 months. Preoperatively, none of the patients were 20/25 or better; at 24 months, 88% of treated eyes were 20/25 or better at near, 76% were 20/25 or better at intermediate, and 71% were 20/25 or better at distance (binocularly, 100% were 20/25 or better). More than 90% of patients were absent or had mild glare and/or halos. There was no difference in perceived ability in night driving ability pre- and postop.
Preoperatively, only 66% of patients were completely satisfied with their vision; postop at 24 months, 87% were completely satisfied with the Raindrop inlay.
ReVision Optics has been working closely with the Food and Drug Administration and has closed Modules 1 and 2 of the application, Modules 3 and 4 have been submitted. The company is awaiting its final Good Manufacturing Practice audit, and it believes it is on track to submit that data in Q2 2016, with an expected approval to follow.
The firm has initiated a US trial of the Raindrop in pseduophakes, in combination with monofocal, toric, or combination intraocular lenses (IOLs). Initial results from a pilot study are encouraging and mimick the outcomes seen in the emmetropic population with more than 90% of patients reporting a near vision of 20/25 or better.
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.