ReVision Optics won pre-market approval from the FDA yesterday for its Raindrop near vision inlay, a corneal implant designed to treat presbyopia.
The Raindrop is a microscopic hydrogel inlay placed in the cornea of the patient’s non-dominant eye during a 10-minute procedure to gently reshape the anterior curvature of the cornea to provide near and intermediate vision, Lake Forest, Calif.-based ReVision said.
“The outstanding clinical results that supported FDA approval of the Raindrop near vision inlay clearly show that patients who have difficulty with near vision due to presbyopia now have a new option to obtain excellent uncorrected vision at all distances,” president & CEO John Kilcoyne said in prepared remarks. “We anticipate commercializing Raindrop in the U.S. to the approximate 2,800 surgeons and 30 million potential patients through a direct field salesforce beginning in the 3rd quarter of 2016.
“We were very impressed by the effort and commitment of the FDA during the PMA approval process, as the agency met or exceeded every milestone during the interactive review of the Raindrop PMA,” Kilcoyne said. “ReVision Optics is also grateful for the leadership and support of Drs. Roger Steinert and Douglas Koch, the medical monitors of the clinical study, and to the dedicated investigators, their clinical coordinators and staff who contributed their time, talents and expertise throughout the 6-year study.”
“Given the prevalence of presbyopia and the aging of the Baby Boomer population, the need for near vision correction will likely rise in the coming years,” Dr. William Maisel, deputy director for science and chief scientist in the FDA’s Center for Devices & Radiological Health, said in prepared remarks. “The Raindrop near vision inlay provides a new option for surgical, outpatient treatment of presbyopia.”