First Retinal Prosthesis Study Of Its Kind Seeks To Partially Restore Vision To The Blind

Main Category: Eye Health / Blindness
Also Included In: Clinical Trials / Drug Trials
Article Date: 19 Nov 2008 - 9:00 PST

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Second Sight® Medical Products, Inc., the leading developer of retinal prostheses for the blind, announced that it will increase patient enrollment for the ArgusTM II Retinal Implant study throughout clinical trials sites within Europe. The three-year feasibility study is currently underway in the United States, Europe and Mexico for people with Retinitis Pigmentosa (RP), a genetic eye disease that causes blindness.

"We are encouraged by the results we have seen in the seventeen individuals that have participated in the study so far," said Robert Greenberg, MD, PhD, President and CEO of Second Sight. "We are now expanding our trial enrollment in order to strengthen our data, further demonstrate clinically meaningful performance and begin the process of seeking market approval."

Retinal Prostheses are currently the only devices being studied to provide some sight to subjects blinded from outer retinal degenerations, such as advanced RP. Second Sight conducted its first proof-of-concept clinical study in early 2002 at Doheny Eye Institute at the University of Southern California (USC) in Los Angeles. During that study, six RP volunteers were implanted with the Argus I system and many continue to use it at home for several hours each day.

The Argus II, the latest device being studied in the clinical trial, is the second generation Retinal Prosthesis that consists of a 60-electrode grid that is surgically implanted on the retina. These electrodes transmit information acquired from an external video camera that is mounted on a pair of eyeglasses worn by implanted subjects. The implant has been designed to last a lifetime, but can safely be removed if necessary.

Preliminary results from the Argus II feasibility study were presented last month at the American Society of Retinal Specialists (ASRS) in Hawaii. According to Mark Humayun, MD, PhD, Professor of Ophthalmology at the Doheny Eye Institute at USC, there were no device failures and few serious adverse events occurred in the 17 subjects that have been enrolled in the study for an average of 14 months, the most serious of which resulted in removal of an implant without difficulty or harm to the individual. Additionally, Dr. Greenberg reported on the orientation and mobility performance observed in the first 11 study volunteers. Using Second Sight's Argus II system, these individuals were frequently able to locate a door up to 20 feet away and walk to the end of a 20 foot line drawn on the floor.

Internationally, three major European centers are participating in the feasibility study, including Service d'Ophtalmologie, Hôpital Cantonal Universitaire de Genève in Geneva, Le Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts in Paris, and Moorfields Eye Hospital in London. Second Sight continues to enroll subjects at these centers and may establish additional clinical trial centers in Europe. Furthermore, the company has made additional improvements to the Argus II system that may increase its clinical benefits.

"These first results hold a novel and quite unprecedented promise for blind subjects as well as the physicians and researchers that have the opportunity to participate in this pioneering endeavor," commented Jose-Alain Sahel, MD, Principal Investigator and Chairman, Department of Ophthalmology, Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts, Paris. "We now have a strong incentive for continuing and expanding the efforts in testing this new technology."

Four leading ophthalmic centers throughout the U.S. have enrolled subjects in the study to date, including Doheny Eye Institute at the University of Southern California (USC) in Los Angeles, CA, Wilmer Eye Institute at Johns Hopkins University in Baltimore, MD, the University of California at San Francisco and the Retina Foundation of the Southwest in Dallas, TX. Second Sight is currently seeking permission from the US Food and Drug Administration to further expand the U.S. trial. The study is also being conducted at Centro de Retina Medica y Quirurgica, SC, Centro Medico Puerta de Hierro, CUCS and Universidad de Guadalajara in Guadalajara, Mexico.

"Retina International and its members in more than 40 countries are excited that this innovative research is now in critical clinical trials and that it is bringing hope to thousands of people with advanced retinal disease," says Christina Fasser, President of Retina International and CEO of Retina Switzerland. The British Retinitis Pigmentosa Society, Retina France, the Fédération des Aveugles de France and the Fondation Ophtalmologique Rothschild have been similarly supportive in Europe.

The development of this technology was largely supported by the National Eye Institute (NEI) of the National Institutes of Health (NIH), and the Department of Energy's Office of Science (DOE) Artificial Retina Project, which is helping to advance the implant's design and construction.

About Second Sight

Second Sight® Medical Products, Inc., located in Sylmar, Calif., is a privately held company founded in 1998 by Alfred Mann and others with the goal of creating a retinal prosthesis to provide sight to subjects blinded from outer retinal degenerations, such as Retinitis Pigmentosa. Through dedication and innovation, Second Sight's mission is to develop, manufacture and market implantable visual prosthetics to enable blind individuals to overcome their disability and achieve greater independence. The company has received extensive U.S. federal support in developing this new technology and is grateful for the forward thinking of the National Institutes of Health/National Eye Institute and the Office of Science at the Department of Energy in supporting significant aspects of this work. For more see http://www.2-sight.com.

This press release contains forward-looking statements. Second Sight Medical Products wishes to caution the reader that actual results may differ from those discussed in the forward-looking statements, and may be adversely affected by, among other things, risks associated with new product development and commercialization, clinical trials, regulatory approvals, reimbursement, and other factors. Second Sight is a registered trademark and Argus is a trademark of Second Sight Medical Products, Inc.

Second Sight® Medical Products, Inc.