The Food and Drug Administration has approved what’s being called the first bionic eye, which may restore limited vision for adults suffering a rare genetic disorder.
The futuristic retinal prosthesis will be used to treat a certain type of blindness called retinitis pigmentosa. Retinitis pigmentosa is a genetic eye condition in which cells of the retina, which are responsible for translating light rays into images in the brain, gradually deteriorate. People with the condition start to lose peripheral vision first, then find it harder to see at night until eventually their central vision is lost as well. The FDA approval came under the “humanitarian use” category, which is limited to devices that annually treat or diagnose fewer than 4,000 people in the United States. Retinitis pigmentosa affects one in every 4,000 Americans.
Around 100,000 people in the US suffer from the condition.
The product, which has been named Argus II, was designed by California-based Second Sight – which focuses on developing, manufacturing, and marketing implantable visual prosthetics. It’s a fitting name for a company which will soon give blind people a second chance at seeing the world around them.
The device consists of a panel of electrodes that are surgically implanted in the eye, and a pair of glasses with an attached camera. The camera sends images to the electrodes, essentially bypassing the damaged retina and tapping into the optic nerve that signals the brain to “see” images.
This will not fully restore patients’ vision, but the FDA said that “it may allow them to detect light and dark in the environment.”
The journal MedGadget writes that patients “who could barely detect an extremely bright light, have reported the ability to recognize large letters and locate positions of household objects” using the Argus II.
“Ten or twenty years ago, people wouldn’t think of the possibility of a bionic eye, and now it’s something that is possible,“ director of the retinal diseases program at the National Eye Institute, Grace Shen, told TechNewsDaily.
Some of the early patients testing the device said they could distinguish boundaries between objects and differentiate light from dark. Some could read large letters, while for others, being able to match sock colors and detect street curbs were more important for helping them to live more independently.
During the FDA review that included reports from 30 participants using the device, the agency found that most patients performed basic tasks, like touching a square in a white field, better with the Argus II than without it and that 19 of the participants experienced no adverse effects to the surgery.
The Argus II is already available in Europe, and will be available at seven hospitals in New York, California, Texas, Maryland and Pennsylvania.
The breakthrough comes after more than 20 years, two clinical trials, more than $100 million in public monies (from the National Eye Institute, Energy Department and National Science Foundation) and $100 million in private investments.
But, as MedGadget notes, there’s competition.
A similar device from Israel-based Bio-Retina reportedly provides nearly 600-pixel clarity, and the company is aiming to develop a 5000-pixel device.