- Second Sight Medical shares jumped to nearly $10 after the
FDA approved its Argus2 Retinal Prosthesis System. - The regulatory approval arrives as Second Sight works to complete a business combination with France's Pixium Vision.
- A decision on when or if to begin production of the new hardware is pending the completion of the deal with Pixium.
Shares of Second Sight Medical Products shot up by nearly tenfold Friday after the Food and Drug Administration cleared for use a visual prosthesis system that the company has redesigned.
The company said its Argus 2s Retinal Prosthesis System was approved initially for use in combination with previously implanted Argus II systems to treat retinitis pigmentosa.
Second Sight shares jumped as much as $8.46, or 592%, to $9.89 before paring the gain to 400% during the session. Volume of 613 million shares was much heavier than the average daily volume of 3.11 million.
Retinitis Pigmentosa is a group of genetic disorders involving a breakdown and loss of cells in the retina, according to the National Eye Institute. The Argus2s, which is comprised of a set of external hardware featuring glasses and a video processing unit, should "enhance comfort and aesthetics compared with the legacy Argus II system," said Matthew Pfeffer, acting CEO of Second Sight, in a statement.
Second Sight is in the process of working on a business combination with Pixium Vision, a French bionic vision systems company. Should the transaction be completed, "the new management team will then evaluate how best to proceed with the Argus 2s Retinal Prosthesis System, as well as all other products in development," said Second Sight.