Retinal Implant Receives USFDA Approval

The Food and Drug Administration has approved the first retinal implant for use in the US. The implant, Second Sight’s Argus II Retinal Prosthesis System, gives hope to those blinded by a rare genetic eye condition called advanced retinitis pigmentosa, which damages the light-sensitive cells that line the retina.

Second Sight went through 20 years of development, two clinical trials and more than $200 million in funding—half from the National Eye Institute, the Department of Energy and the National Science Foundation, and the rest from private investors, before achieving FDA approval. The Argus II has been approved for use in Europe since 2011 and implanted in 30 clinical-trial patients since 2007. The FDA’s Ophthalmic Devices Advisory Panel in September 2012 voted unanimously to recommend approval.

The Argus II includes a small video camera, a transmitter mounted on a pair of eyeglasses, a video processing unit and a 60-electrode implanted retinal prosthesis that replaces the function of degenerated cells in the retina, the membrane lining the inside of the eye.

Although it does not fully restore vision, this setup can improve a patient’s ability to perceive images and movement, using the video processing unit to transform images from the video camera into electronic data that is wirelessly transmitted to the retinal prosthesis.

The company plans to make the Argus II available later this year in clinical centers throughout the US, cultivate a network of surgeons who can implant the device and recruit hospitals to offer it.