Bionic eye gets FDA’s OK

The FDA has approved a bionic eye that improves vision for patients blinded by a rare disease called retinitis pigmentosa.

The Argus II system, a video camera and transmitter mounted on eyeglasses, translates light and movement into electrical signals, which are sent directly to an array of electrodes implanted in a patient’s retina.

Clinical trials have demonstrated that for patients whose retinal cells have been ravaged by the disease, the prosthetic device helps restore the ability to perform many daily activities. The device does not restore vision, but it allows patients to detect light and dark.

Patients who were unable to perceive even bright lights reported that after receiving the device, they could see large letters, locate people and simple objects, and detect movement.

The Argus II, developed by USC biomedical engineer Mark Humayun and built by Sylmar-based Second Sight Medical Products Inc., took more than two decades to develop, with early funding from the Department of Energy, the National Science Foundation and the National Eye Institute.

It is the first of many visual prosthetic devices under development and the first to have demonstrated the capability to hold up under long-term implantation in the human eye.

While millions of Americans have lost sight to more common conditions such as macular degeneration, diabetic retinopathy and glaucoma, the FDA approved the Argus II for a smaller patient population that has progressively lost peripheral, night and central vision as the light-sensitive photoreceptors on the retina have degenerated.

An estimated 100,000 people in the United States suffer from retinitis pigmentosa, which is passed down by gene mutations inherited from one or both parents.

Starting later this year, eye surgeons at seven sites in the United States, including USC’s Doheny Eye Institute in Los Angeles and at UC San Francisco Medical Center, will begin implanting the Argus II system.