Bionic Eye Receives FDA Approval

The bionic eye is one step closer to coming to market as FDA approved the Argus II Retinal Prothesis System today for people who suffer from the rare genetic vision disorder retinitis pigmentosa (RP).

“For many of the approximately 1300 individuals who will develop the disease this year, this technology may change their lives,” William Maisel, deputy director for science and chief scientist at FDA’s CDRH, said in a blog post about the Argus II.

RP, which affects approximately 100,000 people in the U.S., causes light-sensitive cells in the retina to degenerate. This causes a loss in side and night vision, and can lead to blindness. Up until this point, there were no FDA-approved treatments.

The Argus II Retinal Prothesis System, which is already approved for sale in Europe, is made up of a small video camera, a transmitter on a pair of eyeglasses, a video processing unit (VPU) and an implanted retinal prosthesis. The system works by the VPU transforming images from the video camera into electronic data, which is wirelessly transmitted to the retinal prosthesis. This process replaces the function of the degenerated cells in the retina and could potentially improve a patient’s ability to perceive images and movement. It will not restore vision to patients; however, it may allow them to detect the difference between light and dark better and permit them to track the location of people and objects.

The clinical study to approve the device with the FDA involved 30 participants monitored over two years. Following the surgery to place the device, 19 had no adverse side effects to the surgery or the device, while 11 others experienced 23 serious adverse events, such as erosion of the conjunctiva, retinal detachment and inflammation.

Reina V. Slutske is the assistant editor for MD+DI.

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