No Longer In the Dark

By: William Maisel, M.D., M.P.H.

We take so much for granted.

William Maisel, M.D., M.P.H.That was my thought when I first heard about the Argus II Retinal Prosthesis System, a new device approved by the FDA today.

This small electronic device, implanted in the eye, may improve the visual function of patients with advanced retinitis pigmentosa, or RP.

What is RP? It’s a rare genetic eye disease that affects approximately 100, 000 people in the U.S. RP gradually damages the light-sensitive cells that line the retina (a membrane within the eye). In time, a person’s limited ability to tell light from dark can erode. Far too often, the outcome is total blindness.

After carefully reviewing data from a clinical study of 30 patients with RP, FDA is giving the go-ahead to Second Sight Medical Products Inc. to sell the Argus II, the first device of its kind. It has three components: a small electronic device surgically implanted in the eye, a tiny video camera mounted on a pair of glasses and a control unit that is carried by the patient.

The camera captures images. The images become an electric signal. The brain perceives this signal as light.

I could say a lot about how this device works and what it can do for those with RP, but instead, I’ll let patients from the study speak for themselves. Here are excerpts from their comments at the public forum of FDA’s advisory meeting:

“The biggest thing to me was being able to see the crosswalk lines on the street so I can safely cross streets in Manhattan.”

“The most exciting day to me was October 27th, in 2009. It was the first time I was able to see letters on the monitor screen (during a test of visual perception). I had not seen letters since 1994, so that was huge.”

“I have a son who is 17 years old and … I don’t mind telling you how much — I mean, how happy that made me, not only to see the silhouette of my son, but to hear that voice coming and saying, ‘Yeah, it’s me, Dad. I’m here and I love you.’ ”

For many of the approximately 1,300 individuals who will develop the disease this year, this technology may change their lives. And FDA, on the cutting edge of regulatory science, played an important role in that.

It’s the difference between night and day.

William H. Maisel, M.D., M.P.H., is Deputy Director for Science and Chief Scientist at FDA’s Center for Devices and Radiological Health