The FDA said it plans to hold an advisory panel hearing to evaluate the Kamra Inlay device made by AcuFocus to treat presbyopia, or near vision loss.
The FDA’s Ophthalmic Devices Panel will convene June 6 to consider AcuFocus’ bid for pre-market approval for the Kamra device, a ring-shaped inlay that’s implanted under the surface of the cornea, the federal watchdog agency said today.
The Kamra device is designed to reduce the aperture of the eye, improving near vision by increasing the depth of focus. The PMA bid by AcuFocus proposes an indication "for the improvement of near and intermediate vision in presbyopic patients who require near or intermediate correction," the FDA said.
AcuFocus raised $65 million in November 2011 in a round led by Cowen Healthcare Royalty Partners. Prior backers Medtronic (NYSE:MDT), Bausch & Lomb, Accuitive Medical Ventures, Versant Ventures, Carlyle Group and SV Life Sciences also participated.
"[AcuFocus has] great science. It hits an age group that’s post-Lasik, pre-cataract, so there really isn’t a treatment other than glasses," Versant operating partner James Mazzo told MassDevice.com last year. "We’re approved and selling in Japan, we’re approved in many countries across the globe. We just got approval in Canada and Mexico, so we have a very strong global footprint, but obviously the U.S. is a critical phase for this company and takes it obviously to the next level."