AREDS2 expected to boost eye health supplements
study into age related eye disease and nutrition (AREDS2), this
time including lutein, zeaxanthin and omega-3 in the formula, is
welcomed by industry members, who recognise that it will help grow
the category and reduce eye disease incidence.
The NIH said today that it has begun recruiting participants for AREDS2, which aims to build in the positive results from the original AREDS study, announced five years ago exactly.
The AREDS formula, the patent for which is held by Bausch and Lomb, comprises vitamins C and E, beta carotene, zinc and copper. AREDS2 will include the antioxidant carotenoids lutein and zeaxanthin, and the omega-3 fatty acids DHA and EPA.
The nutrients for the new study are supplied by DSM Nutritional Products.
Although the five-year study has yet to get underway, it will raise awareness of the benefits of these nutrients and is expected to boost both ingredient and finished supplement sales - even before the full results are released.
Dr James Elliott, director of nutritional science for DSM Nutritional Products, said: "This study is very exciting and we believe it may help provide further support on the health benefits of lutein, zeaxanthin and omega-3 fatty acid supplementation and demonstrate their potential to help save the signt of thousands of individuals every year."
Since the AREDS study, an expanding body of evidence has amassed linking these three nutrients to a reduced risk of age related macular degeneration (AMD), which causes blurry vision in the central macular of the eye, leaving sufferers with only peripheral vision.
According to the NIH, two million Americans have suffered vision loss as a result of the incurable condition, with a further seven million at risk. There are two forms of the disease - dry and wet. The latter is more serious, and is caused by abnormal growth of blood vessels beneath the macula; dry AMD, which can progress into the wet form, occurs when light-sensitive cells break down.
Lutein and zeaxanthin are known to be present in the macula. The mechanism behind omega-3's putative effect was recently proposed by researchers from the University of Sydney to be down to insufficient fatty acid intake causing abnormal metabolism in the retina, which affects cell renewal (Archives of Opthamology Vol 124, pp 981-986).
Many supplement makers are already using lutein, zeaxanthin and omega-3 in their formulations. For instance, Bausch and Lomb now offers a range of supplements with lutein, other carotenoids and omega-3, building on its original Ocuvite Preservision product that used the AREDS formulation.
Pedro Vieira, sales and marketing manager for lutein supplier Kemin Health, told NutraIngredients-USA.com that the new study is a "fantastic step, and a validation of AREDS… [which was] a break though in nutrition and eye health".
He praised the NIH's recognition of the value of substances that were not recognised as beneficial when the original study was designed, but about which a lot of science has since emerged.
The NIH spokesperson said that the results of AREDS2 will be released five years after the last patient is randomized, so about six and a half years from now. The first patient was randomized last month.
Vieira is certain that any interim results, together with the publicity surrounding the initiation of the study, will help boost sales of the ingredients involved.
He doubted, however, that the AREDS2 formula would be patented in the same way as the first one, partly because of the difficulty that Bausch and Lomb has had in defending its patent, and partly because of the proliferation of products already using lutein, zeaxanthin and omega-3 already on the market.
"A patent would not have much effect," he said.
The study organisers are seeking 4,000 participants aged between 50 and 85 years, who must be available for yearly eye examinations for the next five years.
The original AREDS study involved 4,757 participants aged 55 to 80 years of age, in 11 clinical centres nationwide.
Participants in the study were given one of four treatments: zinc alone; antioxidants alone; a combination of antioxidants and zinc; or a placebo, a harmless substance that has no medical effect.
The results, reported in the October 2001 issue of Archives of Ophthalmology, that the AREDS formula reduced the risk of progression to advanced AMD by 25 percent, and reduced the risk of moderate vision loss by 19 per cent.
