Eye for 
the Blind

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.


1 comment for “Bionic 
Eye for 
the Blind ”

  1. Gravatar of frankfrank
    Posted Tuesday, February 12, 2013 at 11:59:24 AM

    this is great motivational news. i'm wondering if there is a blog to contact patients who has already had the bionic transplant. my questions would be such as would i get my vision back the way it was if it does'nt work? i'm a gentleman who believes that the project has to work a hundreds times, perfecctly, before i'm convince. i think that is fair to say. i've had rp all my life, and my dream is to see my wife again and see my kids again for the first time since childhood. i may be born fifty years to young to actually get my sight back. i'm 54. and i'm optimistic for the medical professions of the opthamology world to cure blindness.


Sign up to receive industry news and events from MD News.

* indicates required