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Bionic Eye Heads Towards Clinical Trials

Bionic Vision Australia (BVA) is seeking investors to take its bionic eye device to a full scale clinical trial. Before this occurs the organisation, which comprises several research groups, will commence a small scale clinical trial, involving three to six patients who will each receive fully implanted devices to use in everyday life.

The BVA bionic eye has been developed for people with retinitis pigmentosa (RP) or age-related macular degeneration (AMD) who have no remaining vision, or residual vision which is far worse than 20/200 (legal blindness).

BVA’s bionic eye consists of a camera attached to a pair of glasses, which captures an image and transmits the data to a processing unit worn on the body. Once processed, data and power is sent to the implanted system wirelessly. An implant situated behind the ear receives the power and signals from the processing unit and sends them to the electrode array via a wire. These pulses stimulate the retina’s remaining cells, resulting in a corresponding perception of patterns of light in the brain.

Following the implant surgery patients learn to interpret these visual patterns and, in doing so, regain some functional vision, allowing them to detect shapes of people and objects in their surroundings.

In a pilot clinical trial, three patients worked with prototype devices in laboratories for two years. According to BVA, the device produced measurable improvements in performance for all three patients and BVA’s novel vision processing software was shown to improve visual tasks. BVA reported that the successful human pilot study and numerous preclinical studies provide strong evidence that the suprachoroidal device is safe, efficacious and a promising intervention for patients with profound vision loss from RP and similar retinal degenerations.

Professor Mark Hargreaves, Chair of the BVA board said the pilot study was critically important to the continuation of research efforts and that results exceeded expectations. “We have demonstrated clearly that our suprachoroidal implants are safe to insert surgically and cause no adverse events once in place. Significantly, we have also been able to observe that our device prototype was able to evoke meaningful visual perception in patients with profound visual loss,” he said.

Professor Tony Burkitt, the Scientific Director of BVA, said this early stage trial produced “fantastic results – the safety and stability we got with the surgical placement was absolutely outstanding, even the functional vision outcomes were way better than we expected.”

He said the next stage of the development process is to undertake a small scale trial with a fully implanted 44 electrode device in the eye and a stimulating chip in the behind-the-ear implanted component (the pilot study involved a 24 electrode device implanted in the eye with an external camera device, which could only be switched on by researchers in a controlled environment).

“The aim is to give patients a fully implanted device they can use in their everyday life, and because of the brain’s plasticity, the more they use it, the more vision they will get from it as the brain gets better at interpreting the signals,” said Professor Burkitt.

Three Devices under Development

The BVA team is developing three different devices; a wide-view 44-channel device which aims to improve mobility and independence for people with significant vision loss; a wide-view 98 channel device, which aims to improve on the quality of vision achieved over the 44 channel device using novel approaches to electrode arrangement and stimulation; and a high-acuity device, which aims to provide high resolution with sufficient functional central vision to enable people to recognise faces and read large print.

There are currently several bionic eye devices under development around the world. In America, the Argus II, developed by Second Sight, was the world’s first device to be approved for use in the US and the European Economic Area. In Australia, researchers at Monash University are also developing a bionic eye based upon direct electrical stimulation of the vision processing area of the brain.

Competitive Advantages

BVA claims its bionic eye differs from other devices because of the novel surgical technique used for implanting, which they report provides greater safety and stability; the vision processing software used; the arrangement and stimulation strategies of the electrodes; the diamond electrode encapsulation for the High-Acuity device; the psychophysics laboratory used to assess functionality of the devices and the “unprecedented expertise and proven track record” achieved in preclinical studies.

A bionic eye that can help restore some vision to people who are legally blind due to RP or AMD is significant. According to BVA, an estimated 1.5 million people around the world have RP. The number of people who are legally blind due to RP is estimated to be 25,000 in the USA, 42,000 in Europe and 375,000 worldwide.

The financial cost of profound vision loss has been estimated at upwards of AU$2.5 billion annually in Australia alone. Worldwide, between 20 and 25 million people suffer from vision loss due to AMD and of these about two million have vision that is considered legally blind or worse.

BVA will commence the small-scale trial mid-2015 with three to six new patients. Each patient will be involved in the research for 18 months. Funding is in place for this trial however BVA is seeking funding for the full-scale multi-centre clinical trial, which will aim to achieve CE approval in Europe and FDA approval in the United States.

Further information about the proposed clinical trials and capital raising can be sought by emailing Dr. Julia Hill, BVA Commercialisation Manager ([email protected]) or Dr. Laurent Rivory, Chairman, Bionic Vision Technologies ([email protected]).