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FDA Approves 'World's First Bionic Eye'

Posted 14 February 2013 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) has announced the approval of a new medical device intended to treat a rare disease population through the use of a retinal implant.

FDA Approval

The device, Second Sight Medical Products' Argus II Retinal Prosthesis System, is intended to treat advanced retinitis pigmentosa (RP), a rare genetic eye condition that is marked by progressive damage done to light-sensitive cells that help people to see in low-light conditions and more fully in general. The condition can also lead to blindness, FDA explained in a statement on the approval.

The device was approved by FDA's Center for Devices and Radiological Health (CDRH) as a humanitarian use device (HUD), but notably supported by a massive government grant--$100 million from the Department of Energy, the National Institute of Health's (NIH) National Eye Institute and the National Science Foundation, collectively. That support covered basic research and material design costs, and is a sum rarely heard of in terms of medical support for a single product.

But an explanation of the device may indicate why it received such wide support.

"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," explained FDA. "The VPU transforms images from the video camera into electronic data that is wirelessly transmitted to the retinal prosthesis."

"World's First Bionic Eye"

In other words, you're looking at what some have dubbed the "world's first bionic eye"-a device whose applications have the potential to go far beyond just RP. Theoretically, the device could be used to restore sight to a number of other sight-impaired patients as well.

FDA said the device was approved based on data obtained from 30 clinical trial participants who received the device. "Most patients were able to perform basic activities better with the Argus II Retinal Prosthesis System than without it," FDA explained.

While the device isn't set to replace any healthy eyeballs soon-efficacy was measured as being able to perform basic activities like recognizing large letters, touching objects and matching socks-FDA's Jeffery Shuren, director of CDRH, said the device was an important first step in an area that has seen little in the way of development.

"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," Shuren said. "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." 

Another problem: Patients either experienced no adverse events, or very serious ones.

Regulators said that 19 of the 30 patients involved in the study experienced no adverse events, while 11 experienced serious adverse events, including "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)."

So while the future of sight medicine may have arrived, it's well worth holding onto your eyeballs for the time being unless you've been diagnosed with RP.


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