Bionic Eye Implant Approved by U.S. for Rare Disease

The Argus II Retinal Prosthesis System. Courtesy Second Sight Medical Products Inc.

Vision-impaired adults with a rare eye disease may regain the ability to do daily tasks, such as walking on the sidewalk, from the first implanted artificial retina to win U.S. regulatory approval.

Closely heldSecond Sight Medical Products Inc., whose chairman is the billionaire inventorAlfred E. Mann, received Food and Drug Administration clearance for its Argus II Retinal Prosthesis System, the agency said in astatementtoday. Argus II helps adults with advanced retinitis pigmentosa, which damages light-sensitive cells that line the retina, causing a gradual loss of vision that may lead to blindness.

While the $100,000-plus system won’t restore sight, it does give patients the ability to perceive the difference between light and dark, the FDA said. The device consists of a video camera, a transmitter mounted on a pair of eyeglasses and a processing unit that transforms images into electronic data that is transmitted to an implanted retinal prosthesis, the FDA said.

“This is a game changer,”Robert Greenberg, president and chief executive officer of Sylmar, California-based Second Sight, said in a statement. The product “represents a huge step forward for the field and for these patients who were without any available treatment options until now,”

A clinical study of 30 people showed the Argus II helped patients recognize large letters or words, detect street curbs, walk on a sidewalk without falling and match black, gray and white socks.

100,000 People

Retinitis pigmentosaaffects about 100,000 people in the U.S., according to the University of Southern California in Los Angeles. Argus II will be available at the Keck Medical Center of USC, according to a statement from the university.

The device will cost more than $100,000, Allison Potter, a spokeswoman for Second Sight, said in an e-mail. The company is working on getting insurers to cover the system to limit the patient co-payment, she said.

Approval will allow Second Sight to begin to recruit hospitals that will offer the device, Greenberg said. The system was approved in Europe in 2011.

As the device is refined, researchers want to one day be able to treat a similar but more common disease called age- related macular degeneration, according to USC. The Doheny Eye Institute at USC helped fund research on Argus II and further study will take place at USC’s Institute of Biomedical Therapeutics.

Of the 30 patients in the study who were followed for two years, 19 experienced no side effects, while others experienced adverse events such as retinal detachment, surgical wounds that split open and erosion of the clear covering of their eyeballs.

The Department of Energy, the National Eye Institute of the National Institutes of Health and the National Science Foundation collaborated to provide $100 million to support the development of the Argus system, the FDA said.

To contact the reporter on this story: Anna Edney in Washington ataedney@bloomberg.net

To contact the editor responsible for this story: Reg Gale atrgale5@bloomberg.net