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FDA approves Hopkins-invented eye implant

Dr. Gislin Dagnelie, right, tests the Argus II on blind subject Marion "Chick" Szczybor
Dr. Gislin Dagnelie, right, tests the Argus II on blind subject Marion "Chick" Szczybor - Steve Ruark
Blind patients in the U.S. who suffer from an inherited eye disease may soon get some of their vision restored with an eye implant invented by the Wilmer Eye Institute at Johns Hopkins in East Baltimore.
The US Food and Drug Administration this month approved the device for the U.S. market and Hopkins will begin implanting the device as soon as September. California firm Second Sight Medical Products Inc. manufactures the device and licensed two patents from Hopkins to develop and commercialize it.
“It’s the first baby steps in applying technology to blindness,” says Gislin Dagnelie, associate professor of ophthalmology at the Johns Hopkins School of Medicine. Dagnelie is part of the original team that invented the device. 
The Argus II Retinal Prosthesis System was approved in Europe two years ago and has helped more than 50 patients there.

It took 20 years of research, two series of trials and $200 million in funding to develop the Argus II. The device restores some vision to patients with late-stage retinitis pigmentosa, a degenerative eye disease. But researchers say the technology holds promise for treating other kinds of blindness notably macular degeneration, the major cause of visual impairment in the aged.
The device consists of a video camera mounted on a pair of glasses that sends visual images to a grid surgically implanted on the retina. The grid converts those images to electrical signals that are sent back to the brain.
The Wilmer Eye Institute at Johns Hopkins Hospital is one of seven U.S. sites where the Argus II will be available as an implant. Other sites are in Los Angeles, Philadelphia, New York and Texas, Second Sight spokeswoman Audra Friis says. Second Sight Medical Products is headquartered in Sylmar, Calif., and in Lausanne, Switzerland.
 “It’s a tremendous advance and it’s leading the way in helping to restore vision using technology,” says Stephen Rose, chief research officer of Columbia’s Foundation Fighting Blindness.  
The foundation was an early donor of the project. Of the funding, half came from the federal agencies National Eye Institute, Department of Energy and National Science Foundation, and half from private sources.
“It’s very exciting to see it come to this point,” says Dagnelie, associate director of Lions Vision Research and Rehabilitation, a division of the Wilmer Eye Institute.
Hopkins receives royalties from the patents, split among the researchers and the Wilmer Eye Institute.
Hopkins participated in the trials on humans that the FDA requires for approval.  A total of five patients received implants of the device, four in 2007 and one in 2009, says Dagnelie, principal investigator for the trials.
“The results were dramatic for a person who has been completely blind,” Dagnelie says.  "It’s not dramatic if you expect to read. It’s very primitive vision. I’d compare it to the cochlear implant [for deafness] 30 years ago, and look how far we’ve come with that,” Dagnelie says. 

“This is not normal vision. But for individuals with no vision, it’s huge,” Rose says. “They can see light and dark, they can see outlines. When they walk into a room that’s lit, they can tell where the sofa is.”

The Argus II will cost more than $100,000 per patient, “The price is expensive so Second Sight is working on getting [insurance] payers to cover so that the patient part is limited,” Friis says.
Dagnelie echoed that sentiment. “The company has to talk about reimbursements. People are not able to pay out of pocket. It has to be covered by Medicare and other medical insurance,” although he expects the company to resolve the medical insurance issue by the summer.
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