The Raindrop Near Vision Inlay has had three of the four modules submitted for the IDE, and the fourth is expected to be submitted some time in Q3 2015. Barring any unforeseen issues, that should put it on track for an Ophthalmic Panel discussion some time in the H1 2016, with a likely approval in the H2 2016. The inlay already has a CE Mark.
Raindrop’s pivotal IDE study enrolled 340 patients, with a 12-month follow-up. Postoperatively, 95% of patients had 20/25 (compared with 2% preop); 94% boasted 20/25 intermediate vision (compared with 34% preop), and 100% had 20/25 distance vision. Complications were few, with blurred vision (1%), glare (2%), and halo (4%) the most common complaints.
In another study, the company is combining the Raindrop Near Vision Inlay with a monofocal or toric IOL. At near, 100% of the patients are 20/25; 85% of patients are 20/32 or better at intermediate.
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.