The U.S. Food and Drug Administration (FDA) approved the Argus II retinal prosthesis system for use in the United States today.
The Argus II, which received a unanimous recommendation for approval by the FDA’s Ophthalmic Devices Advisory Panel in September, restores some visual capabilities for patients whose blindness is caused by Retinitis Pigmentosa (RP). RP is an inherited retinal degenerative disease that affects about 100,000 people nationwide.
“It is incredibly exciting to have FDA approval to begin implanting the Argus II and provide some restoration of vision to patients blinded from RP. In the patients that have been implanted to date, the improvement in the quality of life has been invaluable,” said Humayun, Cornelius Pings Professor of Biomedical Sciences and Professor of ophthalmology, biomedical engineering, cell and neurobiology at USC.
“The fact that many patients can use the Argus implant in their activities of daily living such as recognizing large letters, locating the position of objects, and more, has been beyond our wildest dreams, yet the promise to the patients is real and we expect it only to improve over time,” Humayun said.
The Argus II is manufactured by Second Sight, a company based in Sylmar, Calif. It was approved for use in Europe in 2011 and has been implanted in 30 patients in a clinical trial that began in 2007. Humayun performed many of the surgeries to implant the device.
Today’s FDA approval paves the way for Second Sight to build a surgical network in the United States to implant the device, and to recruit hospitals to offer it, according to Robert Greensburg, President and CEO of Second Sight.
The Argus II system uses a camera mounted on special glasses that sends a signal to an electronic receiver with 60 electrodes that is implanted inside the eye.
The receiver sends signals to the retina that travel through the optic nerve to the brain, where they can be interpreted as a visual picture. The researchers hope that one day the device can be improved to also help individuals with age-related macular degeneration, a similar but far more common disease.
Public inquiries regarding the Argus II can be directed to the Second Sight public information line at (855) 756-3703.
As the Argus II retinal implant is refined, it will be housed in the USC Institute of Biomedical Therapeutics. The new $60-million endowed interdisciplinary institute will bring together scientists, engineers and clinicians from around the world to study neural networks to develop bioelectronic solutions for the millions of people impacted by conditions including traumatic brain injury, stroke and debilitating eye diseases. To learn more about supporting the USC Institute of Biomedical Therapeutics, please call Jeff Kliewer at (213) 740-1360 or email [email protected].
Funding for the development of the device came from the National Eye Institute, the U.S. Department of Energy, the National Science Foundation, and private investment. The Doheny Eye Institute at USC funded Humayun’s work.