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

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[junkie-alert style=”red”] 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. [/junkie-alert]

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.

Will McGuire, President and Chief Executive Officer of Second Sight highlights, “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.”

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.

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 here.