The maker of the world’s first commercial artificial retina, which provides partial sight to people with a certain form of blindness, is launching a clinical trial for a brain implant designed to restore vision to more patients. The company, Second Sight, is testing whether an array of electrodes placed on the surface of the brain can return limited vision to people who have gone partially or completely blind. For decades, scientists have been trying to develop brain implants to give sight back to the blind but have had limited success. If the Second Sight device works, it could help millions of blind patients worldwide, including those who have lost one or both eyes. The device, called the Orion, is a modified version of the company’s current Argus II bionic eye, which involves a pair of glasses outfitted with a camera and an external processor. The U.S. Food and Drug Administration has granted the company a conditional approval for a small study involving five patients at two sites, Baylor College of Medicine and the University of California, Los Angeles. Second Sight still needs to conduct further testing of the device and answer certain questions before starting the trial but hopes to begin enrolling patients in October and do its first implant by the end of the year. Second Sight first won approval in Europe in 2011 for the Argus II, followed by an FDA approval in 2013 (see “Bionic Eye Implant Approved for U.S. Patients”). In Europe, two more retinal prosthetics have since been approved—one is marketed by French company Pixium Vision and another by German firm Retina Implant. Also known as a bionic eye, all three devices are intended to bring back some vision in patients with a genetic eye disorder called retinitis pigmentosa. The disease causes gradual vision loss when light-sensing cells called photoreceptors break down in the retina—the tissue membrane that coats the back of the eye. An estimated 1.5 million people worldwide, including about 100,000 people in the U.S., have retinitis pigmentosa. That is a small percentage of the 39 million people worldwide who are blind, according to the World Health Organization. But Robert Greenberg, Second Sight’s board chair, says the company has only sold about 250 of the Argus II devices, a number lower than he expected. The device costs about $150,000 and restores minimal vision. Only 15 centers in the U.S. offer the technology, and with competition abroad, Second Sight is hoping its new brain implant could be used by far more pople. Second Sight’s Argus II uses a camera mounted on a pair of glasses to capture images. The images are sent to a small, patient-worn processor, which uses special software to convert the images into a set of instructions that are sent to the implanted chip near the retina. Those instructions are then transmitted as a series of electrical pulses to an array of electrodes, also implanted around the eye. People with retinitis pigmentosa are able to benefit from the device because the disease destroys only specialized photoreceptors while leaving the retina’s remaining cells intact. These retinal cells are able to transmit the visual information along the optic nerve to the brain, producing patterns of light in a patient’s field of view. The new device, the Orion, borrows about 90 percent of its technology from the Argus II but bypasses the eye. Instead, an array of electrodes is placed on the surface of the visual cortex, the part of the brain that processes visual information. Delivering electrical pulses here should tell the brain to perceive patterns of light. “In some types of blindness, the optic nerve is damaged so you have to go downstream. With the Orion, we’re essentially replacing the eye and the optic nerve completely,” Greenberg says. With this approach, “anyone who had vision but has lost it from almost any cause could potentially be helped by the Orion technology.”
Californian medical company Second Sight has been granted conditional approval by the US Food and Drug Administration to conduct small clinical trial of its new device, the Orion, which could restore some vision to patients with retinitis pigmentosa. The Orion is a tiny device that uses an array of electrodes implanted in the eye socket to stimulate nerve cells within the retina, restoring vision. The company said people who are blind due to other illnesses could "hypothetically" use the Orion.