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Second Sight Receives Approval from Bundesinstitut für Arzneimittel und Medizinprodukte in Germany to Begin Study to Implant and Evaluate Argus II in Better-Sighted Retinitis Pigmentosa Patients

Oct 17, 2017

SYLMAR, Calif.--(BUSINESS WIRE)--Oct. 17, 2017-- Second Sight Medical Products, Inc. (NASDAQ:EYES) (“Second Sight” or “the Company”), a developer, manufacturer and marketer of implantable visual prosthetics to provide useful vision to blind patients, today announced that the Company has received approval from Bundesinstitut für Arzneimittel und Medizinprodukte (“BfArM”), the German competent authority, and a favorable opinion by the applicable ethics committees, to begin a 10-patient study in Germany to implant and evaluate the Argus® II Retinal Prosthesis System (“Argus II”) in better sighted retinitis pigmentosa (“RP”) patients, or those individuals who have some “tunnel vision.” Tunnel vision is a condition defined by a visual field that is severely constricted.

The clinical study will be conducted with lead principal investigators at three sites in Germany as follows: Universitätsklinikum Aachen with Professor Walter, Städtisches Klinikum Kalrsruhe with Professor Augustin, and Universitätsklinikum Schleswig-Holstein, Universitätsklinikum Lübeck with Professsor Grisanti. The primary endpoint of the study is to measure the improvement of the visual field added by the Argus II for RP patients with tunnel vision. A secondary endpoint will be to evaluate how well those treated with the Argus II integrate the system into their daily lives.

“This is an important study and part of our strategy to evaluate the Argus II in better sighted individuals. We are excited by the opportunity to potentially improve the functional vision of additional blind individuals suffering from RP and look forward to initiating enrollment by the end of this year. If successful, the targeted population could increase the potential market for the Argus II by two to three times its current size,” stated Will McGuire, President and Chief Executive Officer of Second Sight.

Professor Walter, Universitätsklinikum Aachen, commented, “This study has the potential to change the management of patients with RP and, if successful, greatly expand the patient population who can benefit from this treatment, and for whom the Argus II could be a solution.”

Blind patients interested in the Argus clinical trial can contact Second Sight on the toll free number in Germany, 0800 184 4321, and we will refer you to the appropriate clinical site for further details and screening to determine if you are a candidate for this study.

About the Argus II Retinal Prosthesis System

Second Sight's Argus II System provides electrical stimulation that bypasses the defunct retinal cells and stimulates remaining viable cells inducing visual perception in individuals with severe to profound Retinitis Pigmentosa. The Argus II works by converting images captured by a miniature video camera mounted on the patient's glasses into a series of small electrical pulses, which are transmitted wirelessly to an array of electrodes implanted on the surface of the retina. These pulses stimulate the retina's remaining cells, intending to result in the perception of patterns of light in the brain. The patient must learn to interpret these visual patterns, having the potential to regain some visual function. The Argus II was the first artificial retina to receive widespread commercial approval, and is offered at approved centers in Canada, France, Germany, Italy, Russia, Saudi Arabia, South Korea, Spain, Taiwan, Turkey, the United Kingdom, and the United States. Further information on the benefits and risks can be found in the peer reviewed paper at:

About Second Sight

Second Sight's mission is to develop, manufacture and market innovative implantable visual prosthetics to enable blind individuals to achieve greater independence. Second Sight has developed, and now manufactures and markets, the Argus® II Retinal Prosthesis System. Enrollment has been completed in a feasibility trial to test the safety and utility of the Argus II in individuals with Dry Age-Related Macular Degeneration. Second Sight is also developing the Orion™ Visual Cortical Prosthesis to restore some vision to individuals who are blind due to causes other than preventable or treatable conditions. U.S. Headquarters are in Sylmar, California, and European Headquarters are in Lausanne, Switzerland. For more information, visit

Safe Harbor

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange and Exchange Act of 1934, as amended, which are intended to be covered by the "safe harbor" created by those sections. All statements in this release that are not based on historical fact are "forward looking statements." These statements may be identified by words such as "estimates," "anticipates," "projects," "plans," or "planned," "seeks," "may," "will," "expects," "intends," "believes," "should," and similar expressions, or the negative versions thereof, and which also may be identified by their context. All statements that address operating performance or events or developments that Second Sight expects or anticipates will occur in the future, such as stated objectives or goals, or that are not otherwise historical facts, are forward-looking statements. While management has based any forward-looking statements included in this release on its current expectations, the information on which such expectations were based may change. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including those risks and uncertainties described in the Risk Factors and in Management's Discussion and Analysis of Financial Condition and Results of Operations sections of our Annual Report, on Form 10-K, as filed on March 16, 2017, and our other reports filed from time to time with the Securities and Exchange Commission. We urge you to consider those risks and uncertainties in evaluating our forward-looking statements. We caution readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Except as otherwise required by the federal securities laws, we disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto, or any change in events, conditions, or circumstances on which any such statement is based.

Source: Second Sight Medical Products, Inc.

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