SYLMAR, Calif.--(BUSINESS WIRE)--A study recently published online, and set to be issued in the February print edition of the peer-reviewed journal, Archives of Ophthalmology, demonstrated that the Argus® II Retinal Prosthesis System (Argus II – Manufactured by Second Sight Medical Products Inc.) enabled a majority of blind participants, implanted with the device, to identify the direction of moving objects better with the Argus II on than off. This journal article is the latest in a series of publications that shows that the Argus II restores some visual function to patients blinded by retinitis pigmentosa (RP), and that this function translates into real benefits in everyday life. Last month, an FDA Ophthalmic Devices Advisory Panel voted unanimously that the probable benefit of the Argus II outweighs the risks to health, clearing the way for regulatory approval in the US. The Argus II system has been approved for use in the European Economic Area and is on the market in several European countries since last year and remains the only approved retinal implant anywhere in the world.
“The publication of our research in the leading peer-reviewed journal of the American Medical Association reinforces the work our team has done to restore meaningful vision to retinitis pigmentosa Patients,” said Robert Greenberg, MD, PhD, President and CEO of Second Sight Medical Products, Inc. “These results, and other data from the Argus II clinical trial, continue to give new hope to people with retinitis pigmentosa.”
RP is an inherited retinal degenerative disease that often results in nearly complete blindness due to photoreceptor cell death, and affects roughly 100,000 Americans and nearly twice that many in Europe. The Argus II 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 in order to stimulate the remaining cells in the retina. In this study, the users looked at a monitor with a white bar sweeping across a black screen, which resulted in the corresponding stimulation of electrodes on the array and perception of patterns in the visual cortex.
“We found that most of the study participants were better able to determine the direction of the bar when using Argus II than without it,” Dr. Greenberg said. “In other words, this system gave most blind people the ability to identify an object’s direction of motion — something they could not do before.”
Second Sight Medical Products, Inc., located in Los Angeles, California, was founded in 1998 to create a retinal prosthesis to provide sight to patients blinded from outer retinal degenerations. European headquarters are in Lausanne, Switzerland. For more information, go to www.2-sight.com.