Health IT

Beyond the hype of the FDA’s approval of the first bionic eye

bionic eye

It’s easy to get excited when really intriguing and previously unthinkable technology reaches the marketplace.

For example, there’s been a lot of hype in the news leading up to the U.S. Food and Drug Administration’s announcement today that it approved Second Sight Medical’s Argus II Retinal Prosthesis system — the world’s first bionic eye.

The technology behind this device is astounding and complex; it’s taken more than 20 years of research to develop. But it’s also just one incremental step in the ultimate quest for a device that can restore vision to the blind.


Let’s take a step back and put today’s news in perspective.

First, the device (at least for now) is intended to treat a very specific patient population: adults age 25 or over with a severe form of the rare genetic disease retinitis pigmentosa (RP), who have bare light or no light perception in both eyes but still have evidence of inner-layer retina function.

In patients with RP, the photoreceptors in the retina that convert light into electrochemical impulses to be sent to the brain for decoding slowly degenerate over time, which results in gradual loss of vision.  The Argus II is designed to replace the function of those photoreceptors. It comprises a small video camera mounted on a pair of glasses that captures images and sends them to a video processing unit worn by the patient. That processing unit transforms the images into electronic data that are sent wirelessly to electrodes in a retinal prosthesis that’s implanted during a surgical procedure. Those electrodes transform the data into electrical impulses that stimulate the retina’s remaining cells to produce impulses that convert to patterns of light in the brain.

What this has demonstrated in some patients, then, is the ability to allow them to see shapes and movement. “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 said in its announcement today.

Another point to mention is that the device has been approved as a humanitarian device, meaning Second Sight only had to demonstrate that it’s safe, that its benefits probably outweigh the risk of injury or illness and that there is no comparable device on the market. And it apparently did that, as an FDA panel unanimously recommended approval.

But there’s limited data on its effectiveness, and the data that is available is a bit of a mixed bag. In its announcement today, the FDA said it reviewed data from a study of 30 patients with RP in which most of them were able to perform basic activities better with the system than without it. However, more than one-third of them experienced “serious adverse events” related to the device or the surgery, including erosion of the clear covering of the eyeball, splitting open of a wound along the surgical suture, retinal detachment, inflammation and low intraocular pressure, according to the FDA. There’s a clear need for more data to support its widespread use.

Then there’s the price tag. The device was approved in Europe in 2011 and is being sold there for around 73,000 euros, which equates to about $97,500 in the U.S. (and that price is actually expected to be higher in the U.S.)

This technology is a huge step in the right direction for patients with this rare condition, but it’s also a humbling reminder of the patience, diligence and time required for some of the most impactful innovations to reach patients. This is only a first step. There’s still much work to be done.

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