The world’s first ‘bionic eye’, which could help people regain their sight, has been approved for use in America by the Food and Drug Administration (FDA).
Created by Second Sight Medical Products, the retinal prostheses company has been developing the Argus II device for more than 20 years.
Designed to treat patients with late stage retinitis pigmentosa (RP), the announcement follows a unanimous recommendation by the FDA’s Ophthalmic Devices Advisory Panel in September 2012. The device was approved for use across Europe in 2011.
President and CEO of Second Sight, Robert Greenberg, said: “We are thrilled to be able to offer the only FDA-approved long-term therapy for people suffering from advanced RP.
“With this approval, we look forward to building a strong surgical network in the USA 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.”
The device uses a camera and video processor mounted onto sunglasses to send captured images wirelessly to a tiny receiver on the outside of the eye. Once these electrodes are stimulated, messages are sent along the optic nerve to the brain.
Stephen Rose, chief research officer at Foundation Fighting Blindness, added: “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. The Argus II has the potential to provide life-changing vision capabilities, as well as increased mobility and independence.”