FDA panel recommends approval of retinal implant
The U.S. Food and Drug Administration (FDA) Ophthalmic Devices Advisory Panel recommended approval for the Argus II retinal prosthesis system on Sept. 28.
The Argus II restores some visual capabilities for patients whose blindness is caused by RP, or Retinitis Pigmentosa. RP is an inherited retinal degenerative disease that affects about 100,000 people in the United States.
Mark Humayun, who holds joint appointments at the Keck School of Medicine of USC and the USC Viterbi School of Engineering, was a key member of the team that developed the device. He was among the presenters and responders who spoke on behalf of the Argus II at the FDA hearing.
“We’re excited and thrilled to have this positive outcome from the FDA panel, and we will be happy to see this device eventually get to patients for whom there has been no treatment until now,” said Humayun, who is also associate director of research at the Doheny Retina Institute at USC.
The Argus II is manufactured by Second Sight, a company based in Sylmar, Calif. It was approved for use in Europe last year 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.
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.
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.