Retinal prosthesis pioneer company Second Sight Medical Products Inc., has announced that a U.S. FDA Ophthalmic Devices Advisory Panel will take place on September 28th to review the company’s Humanitarian Device Exemption (HDE) market approval application for its Argus II Retinal Prosthesis System (Argus II prosthesis).
RP affects roughly 100,000 Americans and has been designated by the World Health Organisation as a so-called orphan disease, meaning it’s rare. As such, a product targeted at such a condition can be designated as having a Humanitarian Use, making it a candidate for HDE. In 2009, the Argus II prosthesis received a Humanitarian Use Designation (HUD), following which a successful HDE approval will, the company hopes expedite the market introduction of its technology for the target underserved population.
Argus II 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 company submitted its application for approval of the Argus II prosthesis system in May of 2011, based on the results of their international multi-centre 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.
Earlier this year the journal Ophthalmology published encouraging clinical results from a 30 patient study which one of the investigators, Dr. Stanislao Rizzo, Director of the U.O. Chirurgia Oftalmica, Azienda Ospedaliero Universitaria Pisana of Pisa, claimed “The Argus II can, quite simply, help the blind see. Having an approved device backed by significant clinical data is cause for great hope among those patients suffering from RP. There is finally a real solution that means that their vision can be partially restored, safely.”
The data presented in the HDE application will be discussed by the advisory panel, following which, 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.
Source: Second Sight Medical Systems, Inc., Business Wire