Second Sight Receives Approval from Bundesinstitut für Arzneimittel und Medizinprodukte in Germany to Begin Study to Implant...
October 17 2017 - 7:00AM
Business Wire
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:
http://www.sciencedirect.com/science/article/pii/S0161642016305796
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 www.secondsight.com.
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.
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Investor Relations:Institutional
InvestorsIn-Site Communications, Inc.Lisa Wilson,
212-452-2793Presidentlwilson@insitecony.comorIndividual InvestorsMZ North AmericaGreg Falesnik,
949-385-6449Managing DirectorGreg.falesnik@mzgroup.com
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