FDA designates Australian bionic eye as ‘breakthrough’ invention

Australia’s first bionic eye allowing the blind to see has received a key designation in the United States.

A world’s first bionic eye that restores partial vision to the blind has received “breakthrough” designation from the US Food and Drug Administration (FDA).

The designation will help expedite the review and evaluation of the device – whose Australian creators are already claiming to deliver astonishing results.

The managing director of the company behind the eye, Bionic Vision Technologies (BVT), Dr. Ash Attia, described the FDA categorization as a “key step”.

“The life-changing bionic eye can now be delivered more quickly to the people who need it most,” said Dr Attia.

The technology aims to give functional vision to millions of people who have lost their sight due to retinitis pigmentosa (RP) – a genetic disease that damages the retina.

It works through tiny cameras built into a pair of glasses that send electrical signals to an implant behind the eye.

By providing visual information to the blind person, they can gain functional vision, with some carriers reporting being able to recognize loved ones sitting in a cafe.

In a recently published two-year study involving four wearers of the device, participants gained life-changing abilities by giving them more independence around the home.

They were also able to identify key environments such as traffic lights, cars, people, trees, boats and street poles.

The bionic eye was created through a partnership between the Center for Eye Research Australia, the Bionics Institute, CSIRO’s Data61 and the University of Melbourne.

The University of Melbourne has also received a $1.14 million grant from the National Health and Medical Research Council (NHMRC) to work with BVT on the next-generation bionic eye.

The funds will help develop and test a “retinal implant with multi-channel closed-loop stimulation” to further improve patients’ vision.

“RP is a debilitating disease, and the impacts are nothing short of devastating,” said Dr Attia.

“We are all proud to be part of BVT and our entire team is thrilled to lead the world in a project to restore functional vision to those who have lost their precious sight.”

Next year, BVT will conduct a global pivotal study as the next step towards commercialization of this device. The late-stage RP market is estimated at over $5 billion.