Second Sight Medical Products Announces Two-Year Results of its Orion Study
May 12 2021 - 6:00AM
Business Wire
Second Sight Medical Products, Inc. (NASDAQ: EYES) (the
“Company” or “Second Sight”), a leading developer and marketer of
implantable visual prosthetics that are intended to create an
artificial form of useful vision for blind individuals, today
announced two-year results of its Early Feasibility Study (Study)
of the Orion Visual Cortical Prosthesis (Orion). The Study is a
single arm six subject study at UCLA and Baylor College of
Medicine. The Study was paused due to the COVID-19 pandemic, but is
now resumed at both centers. All subjects are still enrolled in the
Study and recent visual function and functional vision results
continue to demonstrate that a majority of participants benefit
from Orion. Five out of five of those tested at the two-year mark
are able to locate a white square on a dark computer screen
significantly better with the Orion System on than with it off.
Four out of five of those tested at the two-year mark are able to
better identify the direction of motion of a bar moving across a
computer screen with the Orion System on. The Functional Low-Vision
Observer Rated Assessment (FLORA) has only been performed with two
subjects due to COVID-19 travel restrictions, but both were rated
as receiving mild positive or positive benefit from the Orion in
real-world settings. The remaining 24-month visits are currently
being scheduled. There has been only one serious adverse event
early in the Study. The event was completely resolved without
hospitalization.
“We are excited to resume the study and see such promising
results, especially after all visits were paused for several months
due to COVID-19,” said Jessy Dorn, Vice President of Clinical and
Scientific Research at Second Sight.
Nader Pouratian, a principal investigator on the Orion clinical
trial and Professor and Chair of Neurological Surgery at UT
Southwestern Medical Center, added, “We have learned about the
therapeutic potential of Orion from the results of this early
feasibility study and feel they support progress toward a larger
study.”
About the Orion Visual Cortical Prosthesis System
Leveraging Second Sight’s 20 years of experience in
neuromodulation for vision, the Orion Visual Cortical Prosthesis
System (Orion) is an implanted cortical stimulation device intended
to provide useful artificial vision to individuals who are blind
due to a wide range of causes, including glaucoma, diabetic
retinopathy, optic nerve injury or disease, and eye injury. Orion
is intended to convert images captured by a miniature video camera
mounted on glasses into a series of small electrical pulses. The
device is designed to bypass diseased or injured eye anatomy and to
transmit these electrical pulses wirelessly to an array of
electrodes implanted on the surface of the brain’s visual cortex,
where it is intended to provide the perception of patterns of
light. A six-subject early feasibility study of the Orion is
currently underway at the Ronald Reagan UCLA Medical Center in Los
Angeles and the Baylor College of Medicine in Houston. No
peer-reviewed data is available yet for the Orion system.
About Second Sight Medical Products, Inc.
Second Sight Medical Products, Inc. (Nasdaq: EYES) develops and
markets implantable visual prosthetics that are intended to deliver
useful artificial vision to blind individuals. A recognized global
leader in neuromodulation devices for blindness, the Company is
committed to developing new technologies to treat the broadest
population of sight-impaired individuals. The Company’s
headquarters are in Los Angeles, California. More information is
available at secondsight.com.
Safe Harbor
This press release contains certain “forward-looking statements”
within the meaning of the “safe harbor” provisions of the US
Private Securities Litigation Reform Act of 1995. Forward-looking
statements can be identified by words such as: “target,” “believe,”
“expect,” “will,” “may,” “anticipate,” “estimate,” “would,”
“positioned,” “future,” and other similar expressions that predict
or indicate future events or trends or that are not statements of
historical matters. Examples of forward-looking statements include,
among others, statements made in this press release regarding the
use of proceeds from the private placement. Forward-looking
statements are neither historical facts nor assurances of future
performance. Instead, they are based only on Second Sight’s current
beliefs, expectations and assumptions. Because forward-looking
statements relate to the future, they are subject to inherent
uncertainties, risks and changes in circumstances that are
difficult to predict and many of which are outside of our control.
Actual results and outcomes may differ materially from those
indicated in the forward-looking statements. Therefore, you should
not rely on any of these forward-looking statements. Important
factors that could cause actual results and outcomes to differ
materially from those indicated in the forward-looking statements
include, among others, the following: (1) legal claims or
proceedings relating to Second Sight’s termination of the
Memorandum of Understanding with Pixium Vision and costs relating
thereto; (2) changes in applicable laws or regulations; (3) the
possibility that Second Sight may be adversely affected by other
economic, business, and/or competitive factors; (4) the impact of
COVID-19 on Second Sight’s business; and (5) other risks and
uncertainties indicated from time to time in Second Sight’s Form
10-K for the year ended December 31, 2020, including those under
“Risk Factors” therein, and in Second Sight’s other filings with
the SEC. Some of these risks and uncertainties may in the future be
amplified by the COVID-19 outbreak and there may be additional
risks that Second Sight considers immaterial or which are unknown.
A further list and description of risks and uncertainties can be
found in Second Sight’s Annual Report on Form 10-K, filed on March
16, 2021. Any forward-looking statement made by us in this press
release is based only on information currently available to Second
Sight and speaks only as of the date on which it is made. Second
Sight undertakes no obligation to publicly update any
forward-looking statement, whether written or oral, that may be
made from time to time, whether as a result of new information,
future developments or otherwise, except as required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20210512005147/en/
Investor Relations: Scott Dunbar
investors@secondsight.com (818) 833-5000
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