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.

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