The FDA is warning about the Raindrop corneal inlay developed by now-fefunct ReVision Optics after 75% of patients in a post-approval surveillance study developed corneal hazing.
Lake Forest, Calif.-based ReVision won pre-market approval from the FDA in June 2016 for the Raindrop inlay to treat presbyopia. The device is a microscopic hydrogel inlay placed in the cornea of the patient’s non-dominant eye during a 10-minute procedure to reshape the anterior curvature of the cornea. ReVision closed its doors earlier this year; RVO 2.0, doing business as Optics Medical, now owns the Raindrop device, which according to the federal safety watchdog is no longer distributed in the U.S.
The FDA nod was based on two-year clinical data showing a 16.1% rate of central corneal haze (60 of 373 patients), a 1.1% rate of patients with two or more lines of loss in vision (4/373) and a device removal rate of 6.4% (24/373); some 29% of those removals were due to corneal haze (7/24), the FDA said.
But the numbers worsened in a five-year, 150-patient post-approval study; interim data showed a 42% rate of central corneal haze (63/150), a 75% rate of any corneal haze (113/150) and a 23.3% rate of device removal to date (35/150); of those, some 31% (11/35) had their Raindrop implant removed due to corneal haze, according to the agency.
“The FDA is advising that eye care providers not implant Raindrop inlays and is working with Optics Medical to have all remaining product on the market recalled,” the FDA said.