FDA OKs eye telescope for common cause of blindness

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A tiny telescope device that can help improve vision in people blinded by age-related macular degeneration won U.S. regulatory approval on Tuesday, offering hope for patients in the last phase of the disease who have no other options.

The device, which is smaller than a pea, is surgically implanted into one eye, replacing the function of the lens and helping to restore central vision that is lost in the age-related disease.

“We’re hoping to help a number of individuals that currently don’t have viable therapeutic options,” Allen Hill, chief executive of privately held VisionCare Ophthalmic Technologies Inc of Saratoga, California, said in a telephone interview.

He estimates there are 70,000 to 80,000 people in the United States with advanced age-related macular degeneration, a disease that gradually destroys the macula, the part of the eye used to see things in fine detail. AMD is a leading cause of vision loss in Americans 60 and older.

Once implanted, the telescope magnifies and projects images to a healthy part of the retina. The other eye then supplies peripheral vision.

Dr. Kathryn Colby of Massachusetts Eye and Ear Infirmary in Boston, who helped develop the surgical technique used to implant the device, said in clinical trials, surgeons were able to place the tiny telescope inside the eye, helping patients to see better.

In one trial of 219 patients, 90 percent gained at least two lines on an eye chart in their ability to see objects at a distance or in visual sharpness.

And 75 percent of patients improved from severe or profound visual impairment to moderate impairment.

Some even regained the ability to recognize people and facial expressions, Colby, one of the study’s investigators, said in a statement.

The device is intended for use in people 75 and older who have severe to profound vision impairment.

“This innovation has the potential to provide many people with an improved quality of life,” said Dr. Jeffrey Shuren of the U.S. Food and Drug Administration’s Center for Devices and Radiological Health.

As part of the approval, the FDA is requiring the company to conduct two post-approval studies to track the product’s safety over time.

The next hurdle will be to win coverage for the procedure through the Medicare insurance program for the elderly, which Hill hopes to have by the first of next year.

“Virtually our entire population in the United States will be the Medicare (population),” Hill said. “We’re focusing almost exclusively on the Medicare reimbursement apparatus.”

Hill said the procedure, which will be done on an outpatient basis, will cost $17,000 to $20,000, with the implant comprising a significant proportion of that.

The company already has approval to market the implant in Europe, but the company is focusing on the United States, Hill said.

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By Julie Steenhuysen

CHICAGO (Reuters)

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