Second Sight Medical Products Receives FDA Approval for Argus II System


Argus II Retinal Prosthesis System.

SYLMAR, Calif.— Second Sight Medical Products, announced that its Argus II Retinal Prosthesis System has received U.S. market approval from the Food and Drug Administration (FDA) to treat people with late stage Retinitis Pigmentosa (RP). Argus II is intended to provide electrical stimulation of the retina to induce visual perception in blind individuals with retinitis pigmentosa. The FDA’s approval of Argus II follows the device’s European approval in 2011, and a unanimous recommendation by the FDA's Ophthalmic Devices Advisory Panel in September 2012 that Argus II be made available to treat the RP patient population in the U.S.

“We are thrilled to be able to offer the only FDA-approved long-term therapy for people suffering from advanced RP,” said Robert Greenberg, MD, PhD, president and CEO of Second Sight. “With this approval, we look forward to building a strong surgical network in the United States and recruiting new hospitals that will offer the Argus II retinal implant. This is a game changer in sight-affecting diseases, that represents a huge step forward for the field and for these patients who were without any available treatment options until now.”

With approval from the FDA, the Argus II is slated to be available later this year in clinical centers across the country, according to Second Sight. The company said it will be adding sites to make the therapy more readily available and encourages interested facilities and patients to contact them.

“This is an exciting time for people who are blind from RP. Second Sight's prosthetic retinal device brings meaningful hope to tens of thousands of people with advanced retinal diseases,” said Stephen Rose, PhD, chief research officer at Foundation Fighting Blindness. He adds, “The Argus II has the potential to provide life-changing vision capabilities as well as increased mobility and independence.”
FDA approval came following more than 20 years of work in the field, two clinical trials, over $100 million in public investment by the National Eye Institute, the Department of Energy, and the National Science Foundation, and an additional $100 million in private investments.

Click here to see Second Sight’s presentation about the Argus II Retinal Prosthesis System at Vision Monday’s 2012 Global Leadership Summit.