FDA panel recommends U.S. approval for Second Sight’s Argus II bionic eye

Published on October 3, 2012 at 4:08 AM · No Comments

On Friday September 28th, a U.S. Food and Drug Administration (FDA) Ophthalmic Devices Advisory Panel unanimously voted 19-0 that the probable benefit of the Argus II Retinal Prosthesis System outweighs the risks to health, an important step toward the FDA market approval of this product manufactured by Second Sight Medical Products, Inc. In making this determination, the panel spent ten 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 Retinitis Pigmentosa (RP).

"We are very pleased with the panel recommendation today. The panel deliberations were well informed and thorough and their decision validated over two decades of work by Second Sight and our collaborators," said Robert Greenberg, MD, PhD, President and CEO of Second Sight. "We would also like to thank all of the people around the world with Retinitis Pigmentosa who volunteered to participate in our clinical trials, and the doctors who treated them. Without their pioneering efforts, today's result would not have been possible."

The panel, which was comprised of 19 voting members with expertise in ophthalmology, retinal disease, low vision, electrophysiology and other specialties heard testimony from Second Sight, the US Food and Drug Administration, 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, the panel 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, $200M of public and private investment, and 10 years after the first person received Second Sight's first Bionic Eye in the clinical trial of the first generation Argus I retinal implant which began in 2002. Many of the hundreds of people that have played instrumental roles in the development of Argus II were moved by the panel recommendation.

"While the European Approval last year was based on the safety and the long term performance of the Argus II Retinal Prosthesis System, the FDA panel required the demonstration of probable benefit as well. This recommendation will now give us the chance to improve the quality of life of thousands of blind patients who have absolutely no other treatment options", said Dr. Lyndon da Cruz, MD PhD Consultant Retinal Surgeon at Moorfields Eye Hospital in London, UK who presented the international trial data to the FDA panel in Washington. "The landmark nature of the moment was reflected by one of the largest FDA panels ever convened and there were numerous patients who had benefitted from the device giving moving testimonies of how the device had changed their lives".

"With seven patients treated in Moorfields Eye Hospital, the largest clinical site in the world, I am very proud to have participated in the world's biggest trial of any retinal implant, and that our research work in the NHS has been seminal in allowing blind patients around the world to get access to this unique and life changing treatment. With both European and recommended US market approval of Second Sight's Argus II bionic eye an historical first has been achieved. We can now begin to see great hope in the future development of this field and the promise of restoration of sight for those who need it most".

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