Feb. 20, 2013 – An artificial retina developed by Retina Implant AG of Reutlingen, Germany, has restored meaningful vision to most of the nine blind people — eight with retinitis pigmentosa, one with cone-rod dystrophy — enrolled in a clinical trial. Five of the participants recognized objects such as door knobs, telephones and facial features. One person was able to read store and restaurant signs, and another was able to observe the movements of a wild goose.
Interim results of the clinical trial were published online in the Proceedings of the Royal Society B: Biological Sciences.
The device, known as the Alpha IMS, consists of an ultra-thin 1,500-pixel chip implanted underneath the fovea, the central region of the retina. It is powered by a battery pack that transfers energy through the skin to a tiny coil connected to the implant. No external camera or glasses are needed.
Retina Implant AG’s clinical trial is taking place in Germany, the United Kingdom and Hong Kong. The company is seeking authorization from the U.S. Food and Drug Administration (FDA) to extend the human study to Wills Eye Institute in Philadelphia.
Walter G. Wrobel, chief executive officer of Retina Implant AG, says the company will seek regulatory approval, known as a CE mark, to market the device in Europe. “While it is impossible to anticipate when, exactly, this milestone will be achieved, the process for application is well underway,” he says. “Ultimately, we will also seek regulatory approval for our artificial retina in the United States."
“As with any cutting-edge technology of this kind, there are technical and surgical challenges, but the company is working those out,” says Dr. Stephen Rose, chief research officer, Foundation Fighting Blindness. “We are excited about the progress being made with Retina Implant AG’s artificial retina, and its potential for restoring vision.”
Interim results of the Alpha IMS clinical trial were released less than a week after Second Sight Medical Products, Inc., of Sylmar, California, received market approval for its artificial retina, the Argus II, from the FDA. In 2011, the Argus II received European marketing approval. It is the first and only artificial retina to receive regulatory approval anywhere in the world.