In September 2012, a US Food and Drug Administration (FDA) Ophthalmic Devices Advisory Panel unanimously voted 19-0 that the probable benefit of a retinal electronic chip system outweighs the risks to health.
This is an important step toward FDA market approval. The Argus II Retinal Prosthesis System, manufactured by Second Sight Medical Products, Inc., is intended to help Retinal Pigmentosis (RP) patients with complete blindness. In 2011, the system received a CE Mark, making it the first approved treatment for severe RP anywhere in the world.
Suber S. Huang, MD, MBA, director, Center for Retina and Macular Disease, University Hospitals Eye Institute, gave the summary statement for the study at the advisory panel meeting and served as the independent medical safety monitor for this international study.
“The system offers a great deal of hope for people who are blind from RP and who currently have no therapy available to them,” says Dr. Huang.
About 100,000 Americans have RP. Approximately 250 will become profoundly blind and qualify for the Argus II. The new technology is eligible for expedited FDA approval under a humanitarian device exemption (HDE), because RP is designated by the World Health Organization (WHO) as an orphan disease.
The FDA recommendation came after more than 20 years of work in the field, three clinical trials, and more than $200 million in public and private investments.