FDA Approved Retinal Implant to Treat Blindness

The FDA has just granted approval to Second Sight Medical Products to begin human clinical study and trials of its newest visual prosthesis known as Orion.

We at A4M and worldHealth.net salute this futuristically creative company for their bold and innovative invention.

Previously, Second Sight, a California-based company, developed a similar successful product called Argus II retinal implant in 2013.

The Argus II employs a pair of special glasses to which a small camera has been mounted. This camera sends its electronic data to a receiver with 60 electrodes implanted inside the patient’s retina. The receiver then sends signals to the retina, then through the optic nerve, and into the brain, where they are extrapolated into vision similar to what a normal eye would produce. The device now available in the U.S., Canada, Europe, and the Middle East is being used to restore vision to people who have blindness caused by an inherited retinal degenerative disease called Retinitis Pigmentosa (RP). This condition only affects about one out of 4,000 people and has a gradual onset. However, this device is also being developed as a treatment for age-related macular degeneration, which affects more than 30 million individuals. Loss of vision by any means is a life altering situation, placing severe limitations on both patient and family alike. Innovations such as Argus II and Orion hold tremendous progress and hope for the future.

Second sight’s goal is to expand the capability of the Argus II with the new Orion product in hopes of restoring vision to other forms of profound vision loss from such sources as: cancer, trauma, glaucoma and diabetic retinopathy. The new Orion system will similarly use an advanced camera mounted on patient glasses, however, the signals will be sent to a chip that is actually implanted into the visual cortex at the back of the brain. The SY-FY ideas of bionic vision are rapidly becoming reality.

There are many questions for which the FDA still needs answers. Accordingly, using normal safety protocols, they are allowing conditional clinical trials at The University of California, Los Angeles and Baylor College of Medicine in Houston. At first only a small number or units will be implanted on a few test subjects for evaluation and testing; before granting full approval.

In one trial cited by Second Sight, the Argus II helped Montreal woman see her child for the first time. She had lost her sight due to RP (retinitis pigmentosa), and very much wanted to see her child. After undergoing a 4-hour procedure for implantation, she was able to see for the first time in years. She said that seeing her youngest child was an incredible experience.

While the device currently does not create “normal” vision, it does give the patient the ability to see basic contours, shapes, and sizes, and sometimes read large print thereby restoring the ability to perform many normal activities of daily living. Safety concerns like crossing the street, and recognizing doorways, shopping aisles, etc. are a real boon to the visually impaired.

It is the goal of this and many other research groups around the world to continue progress toward a truly independent implant with normal or near normal vision. Obviously, a great deal more research, technology and miniaturization has to be accomplished, but it is clear the field is making great progress. In the future, who knows, maybe night vision, infrared, or x-ray vison might become a Star-Trek-like reality.