The U.S. is inching closer to having a retinal prosthesis medical device approved for commercial use. Second Sight Medical Products--one of the few companies in this specialized space--will make its case for the product before the FDA's Ophthalmic Devices Advisory Panel on Sept. 28.
Second Sight, which is based in Sylmar, CA, and Lausanne, Switzerland, submitted its approval application for the system in May 2011. The panel will meet in Gaithersburg, MD, and ultimately recommend whether regulators should approve the company's Argus II Retinal Prosthesis System, based on data from a multi-year international clinical trial testing the system in patients with end-stage retinitis pigmentosa. Since 2009, the product has had a Humanitarian Use Designation, which is intended to expedite development of technologies designed to treat smaller patient populations for which proper treatments are lacking.
The Argus II uses a miniature camera in the patient's glasses to convert video images into a series of small electrical pulses, the company explains. Those are then transmitted wirelessly to electrodes implanted on the retina's surface, with the goal of stimulating the retina's remaining cells. Meanwhile, the brain perceives patterns of light, and patients learn over time to interpret those patterns, regaining some functional vision as a result. Components include the initial implant, glasses, camera and battery.
Retinitis pigmentosa is an inherited degenerative disease involving the retina that affects 100,000 Americans and can result in almost total blindness, the company explains. The World Health Organization considers it an orphan disease, for which there are no viable treatments.
Like many medical device startups these days, Second Sight has made more regulatory progress in the European Union, where the company gained a CE mark in March 2011 for the Argus II. Australia's Monash Vision Group, meanwhile, is fast at work developing a direct-to-brain bionic eye implant, which is on track to begin human trials in 2013.
The Argus II is the first U.S. marketing application for a retinal prosthesis, Second Sight asserts, and is the only approved product of its kind in the world. Second Sight launched in 1998.
- read the release