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NEI-Funded Device for People with RP Gets FDA Approval

February 18, 2013

On February 14, 2013, the U.S. Food and Drug Administration approved the Argus II Retinal Prosthesis System, the first implanted device to treat adult patients with advanced retinitis pigmentosa (RP). RP is a rare genetic eye condition that damages the retina, light-sensitive tissue that transmits signals from the eye to the brain. The condition results in a gradual loss of side vision and night vision and may eventually lead to blindness.

The National Eye Institute, part of the National Institutes of Health, provided support for the development of the Argus II, in addition to the Department of Energy and the National Science Foundation. These government organizations provided grant funding totaling more than $100 million as well as support for material design and other basic research for the project.

The Argus II includes a small video camera, transmitter mounted on a pair of eyeglasses, video processing unit (VPU), and an implanted retinal prosthesis (artificial retina). The device replaces the function of degenerated cells in the retina and may improve a patient’s ability to perceive images and movement. The VPU transforms images from the video camera into electronic data that is wirelessly transmitted to the retinal prosthesis. The Argus II is manufactured by Second Sight Medical Products, Inc., Sylmar, California.

Related Links:

FDA News Release: FDA approves first retinal implant for adults with rare genetic eye disease, February 2013

NEI News Brief: Funded by National Eye Institute, Makers of Bionic Eye Receive Eight Millionth Patent, September 2011