Moment that mattered: The ‘bionic eye’ recieves FDA approval

I’ve always thought the Argus II (a retinal prosthesis, dubbed the ‘bionic eye’, that can restore partial sight to people blinded by degenerative eye disease) was fantastic, and have spent the last few years conducting trials with it in the UK. Approval by the FDA in the US – the holy grail of regulators – is a critical step. Research medicine is littered with things that had promise but failed, and you learn early that if you are at the front end of things, then you may put a lot of time into something that fails. Regulatory permission from the FDA is a very powerful independent verifier that the thing you’ve given a large chunk of your life to is bona fide.

You can treat lots of things as an eye surgeon, but there is a large group of people that you can’t help. They are usually told ‘I am afraid it is too late now, you are blind’. It’s frustrating, so to have a device that starts with the worst cases and actually delivers, as well as offering the possibility of getting better and better over the years is fantastic.

It’s an enormous battle to get a clinical trial to the stage where you do a patient surgery. Before that, it is years of paperwork, battles for funding, regulatory hurdles and petty hospital politics. It can feel like everyone is trying to stop anything from happening at all – so when you do your first patient there is an enormous relief that you have actually made it. It’s a funny position to be in that you have actually taken all the beatings before you even operate.

There is an anxiety [in fitting the device], you are doing something new and difficult that is unfamiliar, but it’s exciting. Those first cases are super moments. When you turn the devices on and the patients say ‘Oh, I see that light’ and they turn to the window and they say ‘Oh, it’s really bright there’ – it’s unequalled. Those moments are very rare in science – they are culminations of enormous amounts of work, they come at very unexpected moments and you are lucky to be there. They go in a flash, by the time you are doing your third case, you’ve got used to it all – but what fleeting moments of sheer wonder!

The big problem is managing the expectations, not just with the patients, but the press. They want to interview patients who have pensioned off their guide dogs, hung up their cane and are playing tennis thanks to their new device. I mean their expectations are almost inconceivable and it’s similar with patients. The regulators require that we tell the patients the worst case scenario, almost to a fault. It’s surprising that anyone joins these trials. They are told that their eye might fall out, there might be disfigurement, pain – there is no question that it is geared to zero outcome. But people still come. They offer something incredible to be part of something special.

At the FDA meeting one of the most moving things was when a guy stood up and said: ‘I had never seen my child. Now I get him to put on a white t-shirt and if the other children who come and play with him wear dark t-shirts, I can see my son running around. I can see him waving. It may be limited, but I know I am seeing my child and for me that’s very important’.

The FDA’s decision means that there is essentially worldwide regulatory approval for the first bionic eye. As the US is the largest market, approval there usually means things will progress. Still nothing is certain, but I believe it is a good thing to be part of. I mean you have to take your chances…

Posted on Thursday, October 26th, 2023 - Categories: #10 - Jan-Mar 2013, App Issues.