The focus of the study is the company’s flagship proprietary product, Lumega-Z, marketed under the company’s NutriGuard brand. It is a micronized lipid-based nutritional formulation designed to restore depleted macular pigments.
The 6-month study compared the efficacy of Lumega-Z to the current standard of care, the AREDS-2 soft gel supplement, marketed under the PreserVision brand by Bausch and Lomb.
Study details
The study, ‘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, a condition where fatty protein deposits develop under the retina near the ‘macula region’, which is the center of the eye responsible for detail and color vision. The two also had delayed dark adaptation recovery time, and were at risk for vision problems from age-related macular degeneration (AMD). The two groups were compared to 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
According to the study, 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. Lastly, the Lumega-Z group displayed a positive linear trend with treatment time in contrast sensitivity (p < 0.001), with benefits visible after three months of using Lumega-Z.
“The Bausch and Lomb product has several attributes which make this comparison a very important parameter to demonstrate higher efficacy. PreserVision is the industry leader for eye health products with $200 million in annual revenue, it is the highest selling branded vitamin (more than Centrum Silver for example) and it is supported by the landmark AREDS-2 study (Funded by the National Eye Institute) which sets the standard for nutritional support for patients at risk of vision loss from Macular Degeneration,” explained David Evans, PhD, Guardion’s interim president, CEO and chief science officer. “To demonstrate that our product is superior shows that we are better than the current standard of care and industry leader, essentially raising the bar for nutritional support of eye disease.”
Insight
Evans, who is also a co-author of the study, told NutraIngredients-USA that a depleted macular pigment is a significant risk factor for vision loss from eye diseases such as macular degeneration, glaucoma and others. He added that Lumega-Z is specifically formulated to protect the macular pigment, with a full array of ingredients known to support this area of the eye.
“The macular pigment is made of three carotenoids, Lutein, Zeaxanthin and Mesozeaxanthin. If people do not get enough of these three carotenoids, the macular pigment can become depleted. It is simple math, a sufficient supply of these three carotenoids equals a more healthy macular pigment. But, these carotenoids are not easily obtained from western diets, and for many people, supplementation is the only way to guarantee the full supply that is needed. This can be particularly true for the older population because their ability to absorb nutrients from their diets is weakened, and supplementation is more important,” explained Evans.
Evans said the biggest difference between the two products is that Lumega-Z contains all three carotenoids, while PreserVision contains two -- Lutein and Zeaxanthin.
“Further, many researchers have speculated that mesozeaxanthin is the most important of the three, because it resides in the very center of the macular pigment, the area with the highest exposure to metabolic activity, and the corresponding oxidative and inflammatory exposure.”
Evans added that Lumega-Z contains other important ingredients, such as astaxanthin, CoQ10 and 20 other ingredients known to support eye health.
“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.”
Source: Nutrients
Nutrients 2020, 12(11), 3271; https://doi.org/10.3390/nu12113271
“Visual Function and Macular Carotenoid Changes inEyes with Retinal Drusen—An Open LabelRandomized Controlled Trial to Compare aMicronized Lipid-Based Carotenoid LiquidSupplementation and AREDS-2 Formula”
Authors: P. Davey et al.