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| An FDA panel voted to recommend the Argus II for approval--courtesy of Second Sight Medical Products |
California's Second Sight Medical Products has accomplished a major milestone in the U.S., gaining FDA approval for the first-ever retinal implant here designed to treat adults who have a degenerative eye disease.
Second Sight's Argus II Retinal Prosthesis System won the FDA's blessing as a treatment for adults ages 25 or older with advanced retinitis pigmentosa, an inherited degenerative disease that can cause blindness by damaging light-sensitive cells that line the retina. Argus II gained approval as a humanitarian use device, which limits treatment to fewer than 4,000 people in the U.S. annually. And some major research money mojo helped fuel development, with grants surpassing $100 million from the Department of Energy, the National Eye Institute at the National Institutes of Health and the National Science Foundation.
Argus II already has approval in Europe.
The device consists of a retinal implant, glasses with an attached video camera and a wireless processing unit worn on a belt. Patients who use the device get a boost to their vision after the camera converts video images into small electrical pulses, and those are transmitted wirelessly to the retina implant, where remaining light-cells receive stimulation. At that point, the brain perceives light patterns, and patients over time learn to interpret the patterns and see various things around them.
The FDA noted Argus II's approval with a formal announcement, an unusual move for the regulatory body.
"This new surgically implanted assistive device provides an option for patients who have lost their sight to retinitis pigmentosa--for whom there have been no FDA-approved treatments," Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement.
Back in September, the FDA's Ophthalmic Devices panel voted 19-0 to back regulatory approval for Argus II. They based their decision, in part, on results from a single-arm feasibility study of 30 patients, where most obtained better visual acuity and half could read 8.9-inch letters from 12 inches away. A small number of patients needed antibiotics or follow-up surgery due to complications, but the company submitted a slightly improved version of the device for approval, which it said addressed the concerns.
- read the FDA release
- here's the company's announcement
- get more from Reuters
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