Study Results Will Be Presented at 39th
Annual Macula Society Meeting
Second
Sight Medical Products, Inc. (NASDAQ:EYES) ("Second Sight" or "the
Company"), a developer, manufacturer and marketer of implantable visual
prosthetics to provide some useful vision to blind patients, announced
it will unveil five-year outcomes associated with the Argus®
II Retinal Prosthesis System ("Argus II") during the 39th Annual Macula
Society Meeting, being held February 24-27, 2016, at Eden Roc Miami
Beach. James Handa, MD, the Robert Bond Welch Professor of Ophthalmology
at the Johns Hopkins University Wilmer Eye Institute, will present the
data for the first time during a session on Inherited Retinal
Degeneration on Wednesday, February 24th at 6:12 p.m. Eastern Time.
Dr. Handa will present long-term results from an ongoing clinical
trial (NCT00407602) assessing 30 individuals from 10 clinical
centers blinded (i.e., with bare light perception or worse) from
Retinitis Pigmentosa (RP) or similar disorders who were implanted with
the Argus II. The data will represent over 200 cumulative patient-years
of clinical trial follow-up and will demonstrate the ability for the
retinal prosthesis to improve visual function over an extended duration.
“The release of this data represents a milestone in the fight against
blindness, given the long-term benefits of the Argus II in restoring
some useful vision to individuals blinded by RP. The extended follow-up
data clearly demonstrate the utility of the Argus II system, and we have
gained considerable knowledge about how best to utilize the device
through this trial,” said Dr. Handa.
“We are excited about what this long-term follow up represents, both for
patients and for our continued development efforts,” said Dr. Robert
Greenberg, Chairman of Second Sight. “These data are compelling in
demonstrating the validity of our approach and the reliability of our
implants.”
One- and three-year data from the trial were previously published in the
peer-reviewed journal Ophthalmology.
For the study, three types of visual function tests were performed using
computer-run assessments: square localization (i.e. object detection),
direction of motion (i.e. motion detection) and discrimination of
oriented gratings (i.e. visual acuity). Two types of real-world
orientation and mobility (O&M) tests were also performed: a test where
patients were asked to locate and touch a door, and a test where
patients were asked to follow a white line on the floor. The Functional
Low-Vision Observer Rated Assessment (FLORA), a multi-part instrument
that was developed specifically for use in patients implanted with a
retinal prosthesis who suffer from profound loss of vision or blindness,
was used to assess the functional visual abilities of patients and how
they use the Argus II to complete a series of common activities of daily
living. Before the development of the FLORA, there were no accepted,
standardized assessments of functional vision or quality of life that
could be used to assess the kind of vision that is restored by a retinal
prosthesis. Common assessment tools of functional vision that are
available such as the National Eye Institute Visual Function
Questionnaire (NEI-VFQ-25) or the Massof Activity Inventory have only a
few items that can be completed by those with ultra-low vision, with the
majority of test items requiring higher levels of spatial vision
(ability to read, recognize faces, identify colors).
Earlier results from this trial were used to gain approval of the Argus
II by the FDA in addition to CE Mark in Europe. The Argus II System is
the first and only retinal implant to have both approvals. Although
there are several research efforts in retinal prostheses worldwide, none
has demonstrated the same level of reliability and efficacy as the Argus
II did in a multi-centered, long-term, controlled clinical trial
involving 30 subjects. Today over 180 patients have been treated with
the Argus II.
Current research efforts by Second Sight include a feasibility study of
the Argus II for individuals with Dry Age-Related Macular Degeneration;
hardware and software upgrades for existing and future Argus II
patients; and the development of a prosthesis for the primary visual
cortex, the Orion™ I Visual Cortical Prosthesis, suitable for patients
with other forms of blindness.
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 (RP). 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 are intended to stimulate the retina's remaining
cells, resulting in the perception of patterns of light in the brain.
The patient then learns to interpret these visual patterns, thereby
regaining some visual function. The system is controlled by software and
is upgradeable, which may provide improved performance as new algorithms
are developed and tested. The Argus II is the first artificial retina to
receive widespread approval, and is offered at approved centers
in Austria, Canada, France, Germany, Italy, Netherlands, Saudi
Arabia, Spain, Switzerland, Turkey, United Kingdom and the United States.
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 manufactures, the
Argus® II Retinal Prosthesis intended to provide some useful vision to
individuals with outer-retinal degenerations such as Retinitis
Pigmentosa (RP). Second Sight is also developing the Orion™ I
Visual Cortical Prosthesis to restore some vision to individuals who are
blind due to causes other than those currently treated by Argus II or
other therapies. U.S. Headquarters are in Sylmar, CA, 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 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 17, 2015 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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