The FDA last week approved the 1st implant designed to correct near vision loss in patients who have not had cataract surgery, the Kamra inlay made by AcuFocus.
The Kamra device, an ultra-thin, opaque ring that’s implanted under the corneal flap of the non-dominant eye in presbyopic patients, is designed to reduce the aperture of the eye and increase the depth of focus.
AcuFocus, which raised a $21 million round last September, won CE Mark approval for the Kamra device in the European Union in 2005. An FDA advisory panel last summer issued a mixed verdict on the inlay, voting that the device is effective but splitting over its safety. The Ophthalmic Devices panel voted 7-1 that Kamra is effective but required chairman Dr. Neil Bressler to break a tie to make the vote 5-4 against on the safety question. The panel was also divided over the Kamra Inlay’s benefits versus its risks, voting 4-3 with 1 abstention that the benefits top the risks.
"Presbyopia is a natural part of aging and can make reading and performing close-up work difficult. The Kamra inlay provides a new option for correcting near vision in certain patients," Dr. William Maisel, deputy center director for science at the FDA’s Center for Devices & Radiological Health, said in prepared remarks.
AcuFocus chairman & CEO Jim Mazzo added that the Kamra inlay is the "number 1 implanted corneal inlay globally."
"After a decade of research, development and clinical investigation, we are delighted to bring this innovative technology to surgeons and patients in the U.S.," Mazzo said in a press release.
Presbia (NSDQ:LENS) is also developing a similar corneal implant, which is being tested in late-stage trials. Presbia raised $42 million earlier this year in an initial public offering.
Material from Reuters was used in this report.