FDA to review Second Sight's retinal prosthesis system

SYLMAR, CA ­– Second Sight Medical Products Inc. has announced that its Argus II Retinal Prosthesis System (Argus II prosthesis) is scheduled to be reviewed by the U.S. Food and Drug Administration (FDA) Ophthalmic Devices Advisory Panel.

Second Sight submitted their Humanitarian Device Exemption (HDE) market approval application in May of 2011, based on the results of an international multi-center clinical trial conducted on patients with end-stage Retinitis Pigmentosa (RP). This trial followed a successful U.S.-based clinical trial of an earlier model, Argus I, which demonstrated proof of concept.

RP is an inherited retinal degenerative disease that often results in nearly complete blindness. It affects roughly 100,000 Americans and has been designated by the World Health Organization as an orphan disease. The Argus II prosthesis received a Humanitarian Use Designation (HUD) in 2009, which makes it a candidate for an HDE approval. This would expedite the introduction of medical devices designed to treat smaller, underserved patient populations.

The Argus II Retinal Prosthesis System works by converting video images captured by a miniature camera in the patient's glasses into a series of small electrical pulses, which are then transmitted wirelessly to electrodes on the retinal surface. These pulses are intended to stimulate the retina's remaining cells, resulting in the perception of patterns of light in the brain. Patients then learn to interpret these visual patterns and regain some functional vision.

If FDA market approval is granted, the Argus II system will become the first ever retinal prosthesis to gain approval in the U.S. The system became the only approved retinal prosthesis anywhere in the world when it received CE Mark approval in Europe last year.