Digital Crave

First FDA-approved eye implant brings light to the blind

Argus IIABC Good Morning America

Last December I told you about a woman who controls a robotic arm with her mind. Today, bionic eyeglasses are the latest example of man making machines to benefit man.

Patients who have lost their vision to late stage retinitis pigmentosa (RP) – a rare genetic disease that affects 100,000 Americans – may have some sight restored via the first FDA-approved eye implant. It’s called the Argus II. The FDA approved the device from Second Sight Medical Products for patients 25 and older; it has also been approved for use in Europe. The implant does not restore vision, but the FDA said the device might allow the blind to see by allowing them “to detect light and dark in the environment.”

The name Argus refers to a character in Greek mythology that was all seeing, with 100 eyes. The new device borrows the name, not the look of its inspiration. Argus II converts video images captured by a miniature camera in the patient’s glasses into a series of small electrical pulses that are transmitted wirelessly to an array of electrodes on the surface of the retina. These pulses are intended to stimulate the retina’s remaining cells resulting in the perception of patterns of light in the brain. The patient then learns to interpret these visual patterns thereby regaining some visual function.

It took 20 years of research and development to create the Argus II. It may not restore sight, but the electrical stimulation to the retina induces visual perception in blind individuals. This could be life-changing to patients currently unable to see anything except, at best, extremely bright lights. Dr. Mark Humayn, who has been working on the Argus II for the past 25 years, told Good Morning America he committed himself “to developing a new way and a new approach so that those that are blind can have a foreseeable solution.”

“One of the things I can do now is laundry,” Kathy Blake told Good Morning America. “My husband had to put the colored clothing in, and with the glasses, I’m able to do that myself.” Blake, 61, has been blind for 23 years. She underwent a two-hour surgery and said she now uses the glasses to help her enjoy walking outdoors.
FDA approval clears the Argus II to be available later this year in clinical centers across the country.

Argus II bionic eyeArgus II bionic eye“We are thrilled to be able to offer the only FDA-approved long-term therapy for people suffering from advanced RP,” said Robert Greenberg, MD, PhD, President and CEO of Second Sight. “With this approval, we look forward to building a strong surgical network in the United States and recruiting new hospitals that will offer the Argus II retinal implant. This is a game changer in sight-affecting diseases, that represents a huge step forward for the field and for these patients who were without any available treatment options until now.”

FDA approval came after more than 20 years of work in the field, two clinical trials, over $100 million in public investment by the National Eye Institute, the Department of Energy, and the National Science Foundation, and an additional $100 million in private investments. RP, an inherited retinal degenerative disease that often results in nearly complete blindness, affects roughly 100,000 Americans. The Argus II System is intended to help the worst-affected RP patients, and this approval was made under a Humanitarian Device Exemption intended to expedite market introduction of technologies intended to treat smaller, underserved patient populations.

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