"Bionic Eye" Approved by FDA

In October last year, what was fast becoming known as the world’s first “bionic eye” gained a nod from a U.S. Food and Drug Administration (FDA) advisory panel. Now, the Argus II Retinal Prosthesis System has been approved by the FDA, making it the first implantable device on the market to treat adult patients with advanced retinitis pigmentosa (RP). The device, which includes a small video camera, transmitter mounted on a pair of eyeglasses, video processing unit (VPU) and an implanted retinal prosthesis (artificial retina), replaces the function of degenerated cells in the retina (a membrane inside the eye) and may improve a patient’s ability to perceive images and movement. The VPU transforms images from the video camera into electronic data that is wirelessly transmitted to the retinal prosthesis. The device is made by Second Sight Medical Products Inc., based in Sylmar, Calif.

RP is a rare genetic eye condition that damages the light-sensitive cells that line the retina. In a healthy eye, these cells change light rays into electrical impulses and send them through the optic nerve to the area of the brain that assembles the impulses into an image. In people with RP, the light-sensitive cells slowly degenerate resulting in gradual loss of side vision and night vision, and later of central vision. The condition can lead to blindness.

“It’s a horrendous disease,” Robert Greenberg, CEO of Second Sight, told The Washington Post. “Their visual world closes in on them gradually until they are completely blind.”

“This new surgically implanted assistive device provides an option for patients who have lost their sight to RP—for whom there have been no FDA-approved treatments,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “The device may help adults with RP who have lost the ability to perceive shapes and movement to be more mobile and to perform day-to-day activities.”

The Argus II system is intended for use in adults, age 25 years or older, with severe to profound RP who have bare light perception (can perceive light, but not the direction from which it is coming) or no light perception in both eyes, evidence of intact inner layer retina function, and a previous history of the ability to see forms. Patients must also be willing and able to receive the recommended post-implant clinical follow-up, device fitting, and visual rehabilitation.

In addition to a small video camera and transmitter mounted on the glasses, the Argus II Retinal Prosthesis System has a portable video processing unit and an array of electrodes that are implanted onto the patient’s retina. The VPU transforms images from the video camera into electronic data that is wirelessly transmitted to the electrodes. The electrodes transform the data into electrical impulses that stimulate the retina to produce images. While the Argus II Retinal Prosthesis System will not restore vision to patients, it may allow them to detect light and dark in the environment, aiding them in identifying the location or movement of objects or people.

The FDA approved the Argus II Retinal Prosthesis System as a humanitarian use device, an approval pathway limited to those devices that treat or diagnose fewer than 4,000 people in the United States each year. To obtain approval for humanitarian use, a company must demonstrate a reasonable assurance that the device is safe and that its probable benefit outweighs the risk of illness or injury. The company also must show that there is no comparable device available to treat or diagnose the disease or condition.

Supporting the device approval was a clinical study of 30 participants with RP who received the Argus II system. Investigators monitored participants for adverse events related to the device or to the implant surgery and regularly assessed their vision for at least two years after receiving the implant. Results from the clinical study show that most participants were able to perform basic activities better with the Argus II system than without it. Some of the activities tested included locating and touching a square on a white field; detecting the direction of a motion; recognizing large letters, words, or sentences; detecting street curbs; walking on a sidewalk without stepping off; and matching black, grey and white socks.

Following the implant surgery, 19 of the 30 study patients experienced no adverse events related to the device or the surgery. Eleven study subjects experienced a total of 23 serious adverse events, which included erosion of the conjunctiva (the clear covering of the eyeball), dehiscence (splitting open of a wound along the surgical suture), retinal detachment, inflammation, and hypotony (low intraocular pressure).

The FDA published a blog post with some comments from participants in last year’s advisory panel meeting. “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,’” said one father. “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,” said another patient.

Some patients have voiced the hope that once Argus has been on the market for some time and proved beneficial to patients with severe RP, the device will be approved for a wider patient base. “I think this could lead, in a very few years, to a fundamental revolution that will end many forms of blindness as a disability,” Karen Shaw Petrou, 59, a Washington banking consultant who has a type of retinal degenerative disease and relies on a guide dog to navigate for her, told The Washington Post. She is not yet eligible for the device, but hopes to soon be. An artificial retina, she said, has the potential to “reach not just the limited class of the totally blind, but across the spectrum of many people with different types of blinding disorders.”

Three government organizations provided support for the development of the Argus II: The Department of Energy, National Eye Institute at the National Institutes of Health and the National Science Foundation collaborated to provide grant funding totaling more than $100 million, support for material design and other basic research for the project.