Argus II Retinal Prosthesis System: first bionic eye awaits FDA approval

Last month, the Food Drug Administration  (FDA) was supposed to approve the Argus II Retinal Prosthesis System by California developer Second Sight, now those in the U.S. who would qualify for the device wait with bated breath as February roars on.

A first of its kind technology, first bionic eye Argus II was already approved for use in Europe in 2011 and is the culmination of 20 years of scientific research into the delicate and deeply complex sight organ.

The implant and eyewear duo will most benefit patients with an inherited form of degenerative blindness that destroys the retina called retinitis pigmentosa, which affects about 3,000 people in the U.S.

Sufferers of the disease experience a gradual retinal generation and an accompanying loss of vision that eventually leads to blindness.

By implanting a series of electrodes inside the eye, the Argus II prosthesis will make up for the failing retina by itself transmitting information about lightness and darkness, for instance, to the brain.

A second aspect of the Argus II is the eyeglass headset.

Patients wear eyeglasses mounted with cameras that then transmit data about what is in front of them to a small wearable computer.

From there, the information is transmitted wirelessly to the implant and the brain is sent a series of electrical impulses the patient eventually learns to interpret as light, dark, and shapes.

“No one really thought it would be possible because the tissue around the eye is so soft and delicate,” Dr. Mark Humayun, of the Keck School of Medicine at USC told the Wall Street Journal.

“If we continue to develop this type of technology and begin to understand the new electrical language of pulses to the brain, to the eye, we can apply it to other parts of the body and we can change our world and how we relate to it,” continued Dr. Mark Humayun, who has been working on the technology for 25 years and is co-creator the Argus II.

One early patient, Elias Konstantopoulos of Glen Burnie, Maryland, had lost his sight completely to retinitis pigmentosa and sought help from the Argus II researchers.

After undergoing the implantation in 2011, Elias Konstantopoulos was able to distinguish between dark and light and used that ability to help him maneuver through space.

His hope is to one day see the face of his grandson, Anthony.

Neither Elias Konstantopoulos nor any of the other recipients of the Argus II in the U.S. and Europe thus far are able to see completely normally.

However, researchers say some of the Argus II recipients are able to identify letters just a few inches tall.

Dr. Mark Humayun says the device’s reliance on an external computer is key to its future success and usefulness.

“Software upgrades will allow us to do more for people – because the implants don’t need to change, the glasses can be enhanced with software upgrades.”

Mark Humayun sees a future where thanks to his device, once-blind patients will see in various colors and even, he says, in digital zoom, just like “your iPhone”.