A manufacturing plan for the newly approved device is on hold until Second Sight completes its business combination with French biotech Pixium Vision SA, the Sylmar biomedical device company said.
Second Sight’s Argus II system uses an implant and a camera mounted a pair of sunglasses to stimulate the optic nerve, giving patients limited vision. The company had originally developed the IIs system for use in combination with previously implanted Argus II systems in blind patients. Participants implanted with the system had been diagnosed with retinitis pigmentosa, a genetic disorder that affects the retina’s ability to respond to light, causing a slow loss of vision, according to the American Academy of Ophthalmology.
Moving forward, Second Sight expects to use the hardware with its next generation Orion Visual Cortical Prosthesis System, currently under development.
“We are very pleased to have received this approval, as it presents an opportunity to offer external hardware that we believe enhance comfort and aesthetics compared with the legacy Argus II system,” Matthew Pfeffer, acting chief executive of Second Sight, said in a statement.
Shares of Second Sight (EYES) skyrocketed up Friday by $4.36, or 305 percent, to $5.79 on the Nasdaq.