Guardion Health Sciences Announces Newly-Published Data Demonstrating Superior Visual Function and Macular Carotenoid Change...
October 28 2020 - 8:30AM
Guardion Health Sciences, Inc. (Nasdaq: GHSI) (“Guardion” or the
“Company”), a specialty health sciences company that develops
clinically supported nutrition, medical foods and medical devices,
with a focus in the ocular health marketplace, announced the
publication of new data in the journal Nutrients. The study
compared the efficacy of Lumega-Z®, the Company’s flagship
proprietary nutritional product marketed under the Company’s
NutriGuard brand, to the current standard of care, the AREDS-2 soft
gel supplement (marketed under the PreserVision® brand by Bausch
and Lomb), as measured by changes in vision following a six-month
regimen.
The study, titled “Visual function and macular
carotenoid changes in eyes with retinal drusen - An open label,
randomized controlled trial to compare a micronized lipid-based
carotenoid liquid supplementation and AREDS-2 formulation,”
compared two groups of patients who had drusen (“drusen” are small
fatty protein deposits under the retina close to the “macula
region”, which is the center of the eye responsible for detail and
color vision), delayed dark adaptation recovery time, and were at
risk for vision problems from age-related macular degeneration
(AMD), and a third control group who were ocular normal. One group
of 25 patients was placed on a 6-month regimen of
Lumega-Z® micronized liquid carotenoid
formulation; one group of 16 patients was placed on PreserVision®
for the same 6-month time period; and the control group of 15
subjects was assigned no ocular nutrition supplement. Results from
the study concluded that Lumega-Z® demonstrated
statistically significant improvements in contrast sensitivity (as
measured by the Company’s widely-accepted contrast sensitivity
testing device, the VectorVision CSV-1000) in both eyes at six
months (p < 0.001), whereas the AREDS-2 supplement gel cap
provided a trend toward increase, but no significant change
(p>.05). The control group showed no change in vision. Finally,
the Lumega-Z® group displayed a positive linear
trend with treatment time in contrast sensitivity (p < 0.001),
with benefits visible after just three months of using
Lumega-Z®.
David Evans, Ph.D., Guardion’s interim President
and Chief Executive Officer, and Chief Science Officer, stated,
“This head-to-head controlled study demonstrates the superiority of
Guardion’s Lumega-Z® formulation in terms of
visual performance over the current standard off-the-shelf AREDS-2
gel caps sold under the PreserVision® brand. It is particularly
notable that the study’s authors highlighted that the benefits of
Lumega-Z® were more rapidly attained.”
Lumega-Z®, the Company’s
proprietary product, is the only micronized lipid-based nutritional
formulation designed to restore a depleted macular pigment.
Previous research shows that a depleted macular pigment may be a
risk factor for vision problems resulting from AMD and other eye
diseases. This study found no difference in macular pigment changes
between the Lumega-Z® and the PreserVision®
groups; however, the Lumega-Z® group showed a
trend toward improvement in the macular pigment in both eyes after
six months, whereas the PreserVision® group showed no trend.
“We firmly believe Lumega-Z®
has the potential to address the significant unmet needs of the
aging population who are at risk for vision problems from
age-related eye conditions,” added Dr. Evans. “This peer-reviewed
publication further supports our strategy of developing products
based on clinically supported nutrition and indicates developing
opportunities in Guardion’s strategy to differentiate and focus its
brands. NutriGuard offers clinically proven nutrition products,
while VectorVision offers scientifically validated diagnostic tools
to measure visual performance, including visual benefits provided
by Guardion’s proprietary nutrition products.”
Dr. Evans is a co-author of the paper referred
to above that was published in the journal Nutrients on October 26,
2020.
About Guardion
Health Sciences
Guardion is a specialty health sciences company
that develops clinically supported nutrition, medical foods and
medical devices, with a focus in the ocular health marketplace.
Located in San Diego, California, the Company combines targeted
nutrition with innovative, evidence-based diagnostic technology.
Guardion boasts impressive Scientific and Medical Advisory Boards.
Information and risk factors with respect to Guardion and its
business, including its ability to successfully develop and
commercialize its proprietary products and technologies, may be
obtained in the Company’s filings with the SEC at www.sec.gov.
Forward-Looking Statement
Disclaimer
With the exception of the historical information
contained in this news release, the matters described herein may
contain forward-looking statements within the meaning of Section
27A of the Securities Act of 1933, as amended, and Section 21E of
the Securities Exchange Act of 1934, as amended. Statements
preceded by, followed by or that otherwise include the words
“believes,” “expects,” “anticipates,” “intends,” “projects,”
“estimates,” “plans” and similar expressions or future or
conditional verbs such as “will,” “should,” “would,” “may” and
“could” are generally forward-looking in nature and not historical
facts, although not all forward-looking statements include the
foregoing. These statements involve unknown risks and uncertainties
that may individually or materially impact the matters discussed
herein for a variety of reasons that are outside the control of the
Company, including, but not limited to, the Company’s ability to
raise sufficient financing to implement its business plan, the
impact of the COVID-19 pandemic on the Company’s business,
operations and the economy in general, and the Company’s ability to
successfully develop and commercialize its proprietary products and
technologies. Readers are cautioned not to place undue reliance on
these forward-looking statements, as actual results could differ
materially from those described in the forward-looking statements
contained herein. Readers are urged to read the risk factors set
forth in the Company’s filings with the SEC, which are available at
the SEC’s website (www.sec.gov). The Company disclaims any
intention or obligation to update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise.
Investor Relations Contact: CORE IR Scott
Arnold 516-222-2560scotta@coreir.com
Media Relations Contact: Jules AbrahamDirector
of Public RelationsCORE IR917-885-7378julesa@coreir.com
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