FDA Approves 'Bionic Eye' for Rare Disease
The Food and Drug Administration has approved the first implantable device, involving a technology called the artificial retina, to treat advanced retinitis pigmentosa, the agency announced on Thursday.
The Argus II system is essentially a video camera and transmitter mounted on eyeglasses which translates light and movement into electrical signals. This is then sent directly to an array of electrodes implanted into a patient's retina.
The technology, made by Second Sight Medical Products of Sylmar, Calif., can be used by patients with retinitis pigmentosa patients ages 25 and up who have severe to profound disease with little or no light perception in both eyes.
Retinitis pigmentosa is a rare genetic condition that affects about 100,000 people in the United States. The condition damages the light-sensitive cells that line the retina. In time, a person's limited ability to tell light from dark can erode, and often the outcome is total blindness.
"It's a horrendous disease," said Robert Greenberg, chief executive of Second Sight, the California-based company that has been developing the Argus II retinal prosthesis for two decades. "Their visual world closes in on them gradually until they are completely blind."
A clinical study of 30 people showed the eye device helped patients recognize large letters or words, detect street curbs, walk on a sidewalk without falling and match black, gray and white socks.
"This is a game changer," Robert Greenberg, president and chief executive officer of Sylmar, California-based Second Sight, said in a statement. The product "represents a huge step forward for the field and for these patients who were without any available treatment options until now,"