FDA Approves First Artificial Retina for Rare Eye Disease
(NEW YORK) — The Food and Drug Administration approved the first retinal implant on Thursday, an advancement that could restore some vision to adults with a particular genetic disorder.
The Argus II system approved by the FDA on Thursday is the first implanted device approved for treatment of advanced retinitis pigmentosa, a rare genetic eye condition that affects the light-sensitive cells that line the retina. The system is intended for use in adults over the age of 25 and may help patients with day-to-day activities such as recognizing letters and words, detecting street curbs and matching pairs of socks.
After an artificial retina is implanted, patients are equipped with a pair of eyeglasses containing a small video camera and a video processing unit. The images from the video camera are converted into electrical impulses which stimulate the implanted retina to produce images, according to an FDA press release.
According to the Washington Post, the artificial retina was approved by European regulators in 2011 and costs approximately $100,000 there. In Europe, the implant is covered by insurance plans.
The Post reports that the surgery to implant the device takes approximately two hours and will be available at about 10 U.S. clinical centers initially. Additional clinical centers are expected to offer the treatment in the future.
The system was approved by the FDA as a “humanitarian use” device, which is limited to products that treat fewer than 4,000 people in the country per year. The FDA reviewed data collected from a clinical trial that included 30 participants and lasted at least two years in order to ensure that patients did not suffer any adverse effects.
While the current technology does not allow patients to see in color, the expectation is that future versions of the implant will provide high-resolution and color images.
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