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UH Eye Institute’s Dr. Suber Huang part of FDA panel recommending approval for retinal chip that could become first bionic eye for blind in US

Wednesday, October 3, 2012

CLEVELAND -- On Sept. 28, a U.S. 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, an important step toward the FDA market approval. The product is called the Argus II Retinal Prosthesis System and is manufactured by Second Sight Medical Products, Inc.

Suber S. Huang, MD, MBA, Director, Center for Retina and Macular Disease University Hospitals Eye Institute and the Philip F. and Elizabeth G. Searle-Suber Huang, M.D., Professor of Ophthalmology and Vice-Chair, Department of Ophthalmology & Visual Sciences at Case Western Reserve University School of Medicine, gave the summary statement for the study at the advisory panel meeting and served as the independent medical safety monitor for this international study.

This device was implanted in profoundly blind patients suffering from retinitis pigmentosa (RP). Noted Cleveland businessman and professional sports owner Gordon Gund is blind from this disease. About 100,000 Americans have RP, which is a progressive disorder. About 250 cases nationwide will become profoundly blind and qualify for this new technology.

“This is very exciting news,” said Dr. Huang. “The system offers a great deal of hope for the people who are blind from RP and who currently have no therapy available to them.”

Dr. Huang will work to have the UH Eye Institute become the country's first non-study site once the FDA officially approves the Argus II under a humanitarian device exemption (HDE). The system qualifies for HDE approval, which means its market approval can be expedited because RP is designated by the World Health Organization (WHO) as an orphan disease.

In making its determination, the FDA panel spent 10 hours carefully reviewing and discussing data submitted from the international clinical trial of this innovative retinal implant that, for the first time ever, partially restores vision to patients who are blind due to RP.

The panel, which was comprised of 19 voting members (23 members total) with expertise in ophthalmology, retinal disease, low vision, electrophysiology and other specialties heard testimony from the sponsor, FDA, and several doctors and participants involved in the most recent clinical trial that began in 2007. After hearing the testimony, asking questions, discussing concerns, and carefully deliberating, they voted unanimously that the probable benefit of the Argus II Retinal Prosthesis System outweighs the risks to health.

This recommendation came after more than 20 years of work in the field, three clinical trials, more than $100 million in public investment by the National Eye Institute, the Department of Energy, and the National Science Foundation, and an additional $100million in private investment.

"Modest gains in vision can make a big difference to a person blinded by retinitis pigmentosa," said Dr. Paul Sieving, Director of the National Eye Institute, in a news release from Second Sight. "The Argus II retinal prosthesis allows users to reclaim their independence and improve their lives. The NEI is proud to have provided support to Second Sight to make the Argus II a reality."

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