A new system approved Thursday Feb. 14 by the Food and Drug Administration (FDA) may help patients who have lost sight regain some of their vision.
The new device is implanted inside of the eye and replaces damaged cells. The Argus II Retinal Prosthesis System is the first treatment for a rare genetic eye disorder that affects the retina membrane of the eye, causing it to deteriorate. The disease is called retinitis pigmentosa, causes the progression of the retina's photoreceptor cells and eventually leads to permanent blindness. These cells are necessary for the retina to capture and process light.
The device does not restore the patients' vision entirely but it may help them to perform daily tasks. Simple daily tasks such as walking on sidewalks and stepping onto curbs, recognizing words and sentences and matching different color socks becomes easier.
"It may allow them to detect light and dark in the environment," says the FDA. A study conducted in which 30 patients were given the implant resulted in them being able to better form daily tasks. Data reports that the disease affects about 100,000 people in the United States.
The FDA estimates that less than 4,000 patients will receive the device under the current approval requirements and regulations. Patients must be at least 25 years old and have advanced retinitis pigmentosa, showing little to no ability to detect light in both eyes. They should at least be able to make out shapes and forms and show signs of even faint remaining function of the retina.
Dr. Jeffrey Shuren, director for medical services at the FDA, said, "This new surgically implanted assistive device provides an option for patients who have lost their sight to RP — for whom there have been no FDA-approved treatments."
The National Institutes of Health, the National Science Foundation and the Department of Energy helped to fund the development of the Argus II by Second Sight Medical Products with $100 million in grants.
"Patients with retinitis pigmentosa in the United States for the first time ever will [now] have a treatment option," said Dr. Robert Greenberg, president and CEO of Second Sight Medical Products Inc.
