Second Sight’s FDA-Approved Artificial Retina Implanted in First U.S. Patients

Achievement date: 
2014
Outcome/accomplishment: 

Artificial retina technology developed by the Biomimetic MicroElectronic Systems (BMES) at the University of Southern California, a recently graduated Engineering Research Center (ERC) funded by the National Science Foundation (NSF), has been successfully implanted in five U.S. patients with retinitis pigmentosa (RP) as of May 2014. This first “bionic eye” to be approved for use in the United States was granted Food and Drug Administration (FDA) market approval in February 2013. By fall 2013, Second Sight Medical Products, Inc. (BMES’ commercial partner) received Medicare reimbursement approval and began moving the bionic eye – known as the Argus II Retinal Prosthesis System – into mainstream applications with current consultation availability at twelve surgical centers throughout the nation.

Impact/benefits: 

RP is a complex genetic disorder that affects one in every 4,000 Americans. Second Sight’s mission is to develop, manufacture, and market implantable visual prosthetics to enable blind individuals to achieve greater independence. The Argus II is the first and only FDA-approved long-term therapy for people with advanced RP in the U.S. and a game-changer device for treating blindness. As a result of the retinal prosthesis, patients with chronic degenerative eye disease can regain some vision to detect the shapes of people and objects in their environment. The sight gained is enough to allow patients to navigate independently, which offers greater mobility and confidence. Recent studies have also shown that the Argus II allows for higher resolution functionality – such as letter and word identification – in some patients. Future work will improve system clarity, helping patients to detect colors, read, and recognize faces. Implant patients must receive training to reawaken visual memory and optimize their use of the device.

Explanation/Background: 

The Argus II system is based on neural prosthetics implant technology first developed over two decades under Mark Humayun at the BMES ERC in collaboration with the University of Southern California, Caltech, and the University of California Santa Cruz. The original concept for the device was a modification of an existing cochlear ear implant. Based in Sylmar, California, Second Sight is a privately held company founded in 1998 by Mr. Alfred Mann, Dr. Sam Williams, and Gunnar Bjorg with the goal of creating a retinal prosthesis to provide sight to subjects blinded from outer retinal degenerations, such as RP. As a key private partner in the project, Second Sight handled clinical trials for the BMES bionic eye before commercializing it; the ERC and its academic partners continue to collaborate with the company to leverage its testing data for augmenting the research and improving the device.

The Argus II includes a small video camera and transmitter housed in a pair of glasses. Images from the camera are converted into a series of electrical pulses that are transmitted wirelessly to an array of 60 microelectrodes implanted on the surface of the retina. The pulses stimulate the retina's remaining healthy cells, causing them to relay the signal to the optic nerve. The visual information then moves to the brain, where it is translated into patterns of light that can be recognized and interpreted, allowing the patient to regain some visual function.

The first clinical trials of the Argus I began in 2002 and included six subjects in total. A two-patient pilot study was initiated in Mexico in 2006 for the Argus II, followed by a 30-patient trial in ten centers across Europe and the United States. The first U.S implants were performed at the University of Michigan’s Kellogg Eye Center, which has been selected by Second Sight as one of twelve “Centers of Excellence” capable of providing the cutting-edge treatment. In addition to the U.S., the device has been approved and implanted in patients in Germany, Italy, France, and the Netherlands. The bionic eye costs about $150,000 plus the cost of surgery.

RP is an inherited disease that causes slow but progressive vision loss due to a gradual loss of the light-sensitive retinal cells called rods and cones. Patients experience loss of side vision and night vision, then central vision, which can result in near blindness. While the complex disorder damages photoreceptors and ultimately destroys central vision, it is possible to bypass the partly damaged retina using electronics to restore functional neurons affecting vision.