US regulators approved a so-called bionic eye, giving hope to people with a rare genetic disease.
Developed by California-based Second Sight Medical Products, Inc., the Argus II Retinal Prosthesis System is the first retinal implant for adults with advanced retinitis pigmentosa that results in the gradual loss of vision and can lead to blindness.
"While the Argus II Retinal Prosthesis System will not restore vision to patients, it may allow them to detect light and dark in the environment, aiding them in identifying the location or movement of objects or people," the US Food and Drug Administration said in a statement announcing its decision.
The device includes a small video camera and a transmitter mounted on a pair of glasses, as well as a video processing unit and an implanted retinal prosthesis that replaces the function of degenerated cells in the retina.
"This new surgically implanted assistive device provides an option for patients who have lost their sight to RP (retinitis pigmentosa), for whom there have been no FDA-approved treatments," said Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health.
"The device may help adults with RP who have lost the ability to perceive shapes and movement to be more mobile and to perform day-to-day activities."
Already greenlighted by European regulators, the FDA approved the Argus II as a humanitarian use device, which is limited to instruments that treat or diagnose fewer than 4,000 people in the United States annually.
Second Sight welcomed the news, calling it a game changer.
"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," said president and CEO Robert Greenberg.
"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."
Second Sight Medical Products, Inc. is a medical device company founded in 1998 and located in Sylmar, California and with an office in Lausanne, Switzerland. Through dedication and innovation, Second Sight’s mission is to develop, manufacture and market implantable visual prosthetics to enable blind individuals to achieve greater independence.
The company is privately held and most of the investors are individuals, including Mr. Alfred E. Mann who has started many medical device companies such as Pacesetter, MiniMed, Advanced Bionics, and Mannkind. Versant Ventures is a venture capital firm that also holds a stake in Second Sight.