[Nfbf-l] FDA approves first retinal implant for rare eye disease

[Alan Dicey]

FDA approves first retinal implant for rare eye disease
Thu, Feb 14 17:12 PM EST
By Julie Steenhuysen (Reuters) -
The U.S. Food and Drug Administration has approved the first artificial 
retina, an implanted device that replicates some of the function of the 
retina, helping to restore vision to people blinded with a rare genetic 
disorder, the agency said Thursday.

The device, made by privately held Second Sight Medical Products Inc of 
Sylmar, California, is intended to replace the function of light-sensing 
cells in the retina destroyed by retinitis pigmentosa, an inherited 
degenerative disease that affects about 100,000 people nationwide.

In a healthy eye, the retina, which lines the back of the inner eye, works a 
bit like film in a camera, converting images that come through the eye's 
lens into electronic signals that are relayed to the optic nerve in the 
brain.

To replicate this, the Argus II device consists of special glasses outfitted 
with a video camera and a video processing unit that sends signals to a 
wireless receiver implanted in the eye.

Although it does not completely restore vision, the implant helps with daily 
activities, such as locating objects and recognizing large letters and 
shapes.

"In the patients that have been implanted to date, the improvement in the 
quality of life has been invaluable," said Mark Humayun of the University of 
Southern California's Keck School of Medicine and USC's Viterbi School of 
Engineering, who helped develop the device.

The Argus II was approved for use in Europe in 2011 and has been implanted 
in 30 patients in a clinical trial that began in 2007. In October, advisers 
to the FDA voted unanimously to approve the device.

Brian Mech, vice president of business development at the company, said the 
system will cost more than $100,000 when it is launched in the United 
States, sometime this year.

Mech said the company is working with insurance companies and Medicare to 
win coverage and ease out of pocket expenses for patients.

The Argus II is intended to replace the function of light-sensing 
photoreceptor cells, which gradually become degraded in retinitis 
pigmentosa.

To restore vision, signals from the camera are sent to the retina, where 
they travel to the optic nerve in the brain. The brain then receives these 
signals and interprets them as a visual picture.

The FDA approved the system as a humanitarian use device, an approval that 
is limited to fewer than 4,000 people in the United States each year. For 
this kind of approval, companies must show the device is safe and the 
probable benefit outweighs the risks.

In the clinical trial, most of the 30 participants improved in their ability 
to see and touch a square on a white field, detect the direction of a 
motion, recognize large letters and sentences, see street curbs and even 
match socks.

To receive the Argus II device, patients must have had the ability to see 
forms in the past and must be willing and able to get the recommended 
follow-up care and training.

The device is limited to adults 25 or older, with severe to profound 
retinitis pigmentosa who have no light perception or bare light perception, 
in which they can perceive light but cannot tell where it is coming from.

The team plans to keep improving the treatment, which they hope will 
ultimately be used to treat age-related macular degeneration.

Mech said while there are many academic centers working on retinal implants, 
getting the system to market took 14 years, $200 million, and a lot of 
"intestinal fortitude." (Reporting by Julie Steenhuysen in Chicago and Esha 
Dey in Bangalore; Editing by Sreejiraj Eluvangal and Cynthia Osterman)



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