Second Sight Medical Products Inc., the world's leading developer and manufacturer of retinal prostheses, today announced that a U.S. Food and Drug Administration (FDA) Ophthalmic Devices Advisory Panel has been scheduled to review the data presented in the company's Humanitarian Device Exemption (HDE) market approval application for its Argus II Retinal Prosthesis System (Argus II prosthesis) on September 28, 2012 in Gaithersburg, Maryland. The company submitted their application for approval of the system in May of 2011, based on the results of their international multi-center clinical trial conducted in patients suffering from end-stage Retinitis Pigmentosa (RP). This trial, which began in 2007, followed a successful U.S.-based clinical trial of the earlier Argus I, which began in 2002 and demonstrated proof of concept.
RP, an inherited retinal degenerative disease that often results in nearly complete blindness, affects roughly 100,000 Americans and has been designated by the World Health Organization as an orphan disease. In 2009, the Argus II prosthesis received a Humanitarian Use Designation (HUD), making it a candidate for an HDE approval which is intended to expedite the market introduction of technologies intended to treat smaller, underserved patient populations.
The system works by converting video images captured by a miniature camera, housed in the patient's glasses, into a series of small electrical pulses that are transmitted wirelessly to an array of electrodes on the surface of the retina. These pulses are intended to stimulate the retina's remaining cells resulting in the corresponding perception of patterns of light in the brain. Patients then learn to interpret these visual patterns thereby regaining some functional vision.
The data presented in the HDE application will be discussed by the advisory panel. 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.
Second Sight Medical Products Inc.,