Thursday, February 14, 2013

FDA Approves Argus II for RP

After more than 20 years of research and development, the Food and Drug Administration has approved the Argus II retinal prosthesis system for the treatment of alte stage retinitis pigmentosa. That's the word from Second Sight Medical Products, Inc., which spent more than two decades researching the product. The FDA's actions follow receipt of the European approval in 2011 and a unanimous recommendation by the FDA’s Ophthalmic Devices Advisory Panel in September 2012. The company says that the product provides electrical stimulation of the retina to induce visual perception individuals blinded by retinitis pigmentosa. Although the resulting vision is not the same as when these patients had normal vision, investigators involved in the clinical trial of the Argus II are eager about the approval. Read more.

Here's a more detailed article in the New York Times: "The Food and Drug Administration on Thursday approved the first treatment to give limited vision to people who are blind, involving a technology called the artificial retina. The device allows people with a certain type of blindness to detect crosswalks on the street, the presence of people or cars, and sometimes even large numbers or letters. The approval of the system marks a milestone in a new frontier in vision research, a field in which scientists are making strides with gene therapy, optogenetics, stem cells and other strategies. ...The artificial retina is a sheet of electrodes implanted in the eye. The patient is also given glasses with an attached camera and a portable video processor. This system, called Argus II, allows visual signals to bypass the damaged portion of the retina and be transmitted to the brain.” Read more.

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