The Food and Drug Administration (FDA) Thursday approved the first retinal implant for use in the United States. The FDA’s green light for Second Sight’s Argus II Retinal Prosthesis System gives hope to those blinded by a rare genetic eye condition called advanced retinitis pigmentosa, which damages the light-sensitive cells that line the retina.
For Second Sight, FDA approval follows more than 20 years of development, two clinical trials and more than $200 million in funding—half from the National Eye Institute, the Department of Energy and the National Science Foundation, and the rest from private investors. The Argus II has been approved for use in Europe since 2011 and implanted in 30 clinical-trial patients since 2007. The FDA’s Ophthalmic Devices Advisory Panel in September 2012 voted unanimously to recommend approval.
The Argus II includes a small video camera, a transmitter mounted on a pair of eyeglasses, a video processing unit and a 60-electrode implanted retinal prosthesis that replaces the function of degenerated cells in the retina, the membrane lining the inside of the eye. Although it does not fully restore vision, this setup can improve a patient’s ability to perceive images and movement, using the video processing unit to transform images from the video camera into electronic data that is wirelessly transmitted to the retinal prosthesis.
Retinitis pigmentosa—which affects about one in 4,000 people in the US and about 1.5 million people worldwide—kills the retina’s photoreceptors, the rod and cone cells that convert light into electrical signals transmitted via the optic nerve to the brain’s visual cortex for processing. Second Sight plans to adapt its technology to someday assist people afflicted with age-related macular degeneration, a similar but more common disease.
Via Dr. Stefan Gruenwald