By Eye² Staff
The Argus II retinal prosthesis system may soon become the first ever bionic eye for the blind available in the U.S. In September, the U.S. Food and Drug Administration (FDA) Ophthalmic Devices Advisory Panel unanimously voted 19 to 0 that the probable benefit of the Argus II Retinal Prosthesis System outweighs the risks to health, an important step toward the FDA market approval of this product manufactured by
Second Sight Medical Products, Inc.
“The successful launch of Argus II in Europe, and its impact on the lives of these blind patients who have no treatment alternative, has been very gratifying,” Brian Mech, Second Sight’s vice president for business development, told Eye2. “There has been a groundswell of interest from the ophthalmic community around the world. In the US, we are in the final stages with the FDA and expect approval soon. Anticipating this approval we are tackling the next challenge, which will be reimbursement.”
The FDA panel’s recommendation came after more than 20 years of work in the field, three clinical trials, over $100M in public investment by the National Eye Institute, the Department of Energy, and the National Science Foundation, and an additional $100M in private investment.
How it Works
Argus II provides electrical stimulation of the retina to induce visual perception in blind individuals. A miniature video camera housed in the patient’s glasses captures a scene. The video is sent to a small patient-worn computer (i.e., the video processing unit—VPU) where it is processed and transformed into instructions that are sent back to the glasses via a cable. These instructions are transmitted wirelessly to an antenna in the retinal implant. The signals are then sent to the electrode array, which emits small pulses of electricity. These pulses bypass the damaged photoreceptors and stimulate the retina’s remaining cells, which transmit the visual information along the optic nerve to the brain, creating the perception of patterns of light. Patients learn to interpret these visual patterns with their retinal implant.
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