(BN) Bionic Eye Implant Approved by U.S. for Rare Disease

(Bloomberg ) Adults going blind because of a rare eye disease may regain the ability to do daily tasks, such as navigating a sidewalk or detecting sunlight, from the first implanted artificial retina to win U.S. regulatory approval.

Closely held Second Sight Medical Products Inc., whose chairman is the billionaire inventor Alfred E. Mann, received Food and Drug Administration clearance for its Argus II Retinal Prosthesis System, the agency said yesterday in a statement. 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 gives patients the ability to perceive the difference between light and dark. 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 sent to an implanted retinal prosthesis, the FDA said.

"I became completely blind and I didn't have nothing to lose," Elias Konstantopoulos, 74, who volunteered to have Argus II implanted in 2009 as part of Second Sight's clinical trial, said in a telephone interview. Now, he said, "there's a lot of hope."

Konstantopoulos, of Glen Burnie, Maryland, said he was diagnosed with retinitis pigmentosa when he was in his early 40s and became completely blind about six months ago. He can see shadows now with the device and tell if the sun is behind a tree. Argus II is comfortable and the surgery was painless, he said.

Game Changer

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

"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,"

Retinitis pigmentosa affects 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 with insurers to cover the system to limit the patient copayment, she said.

USC Hospital

Approval by the FDA allows 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 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 provided $100 million to support the development of the Argus system, the FDA said.