|Second Sight's Argus II--Courtesy of Second Sight Medical Products|
This California company scored something big in 2013, becoming the first in the U.S. to gain the FDA's approval for a retinal implant designed to treat adults with a degenerative eye disease.
Second Sight's Argus II Retinal Prosthesis System is approved as a humanitarian use device to treat adults ages 25 or older with advanced retinitis pigmentosa, an inherited condition that can cause blindness by damaging light-sensitive cells lining the retina. The approval status limits treatment to fewer than 4,000 people in the U.S. each year.
While the approval status limits Argus II's U.S. market potential, it already has an EU regulatory nod. The FDA's approval was a long time coming. A company official told Reuters in February that Second Sight took 14 years and $200 million to bring its signature product to this point. More than $100 million of that stems from grants awarded by the Department of Energy, the National Eye Institute at the National Institutes of Health and the National Science Foundation. Before the approval, the FDA's Ophthalmic Devices Panel backed approval of the device in a 19-0 vote in September 2012.
Argus II encompasses three major components: a wireless processing unit worn on a belt, glasses with an attached video camera and a retinal implant. The camera converts video images into small electrical pulses that are transmitted wirelessly to the retinal implant, which then stimulates the remaining light cells in the eye. A patient's brain perceives light patterns at this point, but over time, patients learn to decipher the patterns and see details around them.
Second Sight scores victory with FDA nod for retinal prosthesis