FDA approves eye implant that helps restore vision in patients with retinal disorder
WASHINGTON — Patients who have lost their sight as a result of a rare disorder might be able to regain some vision using an implantable device that takes the place of damaged cells inside the eye.
The Food and Drug Administration approved the Argus II Retinal Prosthesis System as the first treatment for an inherited disorder that causes the breakdown of cells in the retina, a membrane inside the eye.
The technology will initially be available to a small number of patients, but could eventually be used to treat vision disorders that affect millions of people. The device was previously approved in Europe in 2011.
The system includes a small video camera and transmitter mounted on a pair of glasses. Images from the camera are processed into electronic data that is wirelessly transmitted to electrodes implanted into the patient's retina.
FDA says that while the device will not fully restore patients' vision, “it may allow them to detect light and dark in the environment,” which could help them perform daily tasks.
The FDA approved the device from Second Sight Medical Products for patients 25 and older who have advanced retinitis pigmentosa. Starting in their twenties, people with the disease slowly lose vision as the light-sensitive cells that line the retina deteriorate. Over a period of decades the condition eventually leads to blindness.
Dr. Robert Greenberg, CEO and founder of Second Sight, first proposed the technology for the Argus device as a doctoral student at Johns Hopkins University's medical school about 20 years ago. He founded Second Sight to develop the technology in 1998.
About 100,000 people in the United States have retinitis pigmentosa, though the FDA estimates fewer than 4,000 will initially receive the device under its currently approved indication. Patients must have little to no light perception in both eyes but a prior history of being able to make out basic shapes and forms. They also must have signs of at least some remaining retinal function.