AREDS2 Study Design and Results

A few weeks ago, the AREDS2 results were officially released! AREDS2 showed that…

PreserVision AREDS 2 Vitamin & Mineral Supplement 120 Count Soft Gels

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  • TAG : AREDS 2 Results - Macular Degeneration
  • Viteyes® AREDS 2 supplements contain the clinically effective formula tested by the National Eye Institute ("NEI") in its 2013 AREDS2 study. AREDS 2 is a follow up study to the original AREDS study. The first AREDS study was completed in 2001 and showed that a combination of antioxidants and zinc could help to reduce the risk of progression for age-related macular degeneration by 25% when taking an AREDS formula. The AREDS2 study, completed in 2013, suggests that removing beta-carotene from this formula and adding lutein and zeaxanthin can help to reduce the risk of progression to advanced AMD by 18% compared to the original AREDS formula.

    In 2006 the National Eye Institute (NEI) launched AREDS2, a six-year study designed to test whether the original AREDS formulation could be improved by adding omega-3 fatty acids (EPA & DHA); adding lutein and zeaxanthin; removing beta-carotene; or reducing zinc. Conducted at 82 clinical sites across the US, the trial included 4,203 participants, ages 50-82.

  • For example, ethyl ester based omega-3 fatty acids did not prove effective, even though there are 60+ peer-reviewed articles that show omega-3 fatty acids from fish oil do have both a protective and therapeutic effect for AMD. Another key finding of AREDS2 is that lutein and zeaxanthin may be safer than beta-carotene in reducing risk of disease progression.

    The null effect of omega-3 was the biggest surprise, once again because there is overwhelming evidence from other studies that omega-3 is effective in preventing and slowing the progression of AMD. One theory being debated by eye physicians and nutritionists is that AREDS2 used ethyl ester (EE) omega-3 fish oil instead of the natural triglyceride (TG) form, which is generally recognized as being better absorbed by cells.

    Macular Degeneration and Nutrition: AREDS vs. AREDS2

    In 2001, the National Eye Institute, part of the National Institutes of Health, completed the Age Related Eye Disease Study (AREDS), which showed that ingesting high levels of specific nutritional supplements decreased the risk of macular degeneration (AMD) progression. This included 25,000 IU of beta-carotene, 500 mg of Vitamin C, 400 IU of Vitamin E, 80 mg of Zinc and 2 mg of Cupric Oxide.

    While AREDS was the first study demonstrating benefit against this retinal eye disease, if failed to demonstrate improvement in vision. More recent studies, including the Lutein Antioxidant Supplement Trial, have demonstrated vision improvement, something AREDS could not. And much exciting work involving both Lutein and Zeaxanthin, molecules known as carotenoids, have shown not only vision improvement but also a healthier macular appearance.

    Finally, there appears to be an inflammatory component to Age-Related Macular Degeneration. Hence, Omega-3 fatty acids, which are derived from deep sea fish, may be helpful in further counteracting this eye disease and preventing blindness.

    Hence, the National Eye Institute, in late 2006 announced the recruitment of patients into a multi-year randomized Age Related Eye Disease 2 Study.

    The Age Related Eye Disease Study 2 site states:

    "The Age-Related Eye Disease Study 2 (AREDS2) is a multi-center, randomized trial designed to assess the effects of oral supplementation of macular xanthophylls (lutein and zeaxanthin) and/or long-chain omega-3 fatty acids (docosahexaenoic acid) [DHA] and eicosapentaenoic acid [EPA] ) on the progression to advanced age-related macular degeneration (AMD).  An additional goal of the study is to assess whether forms of the AREDS nutritional supplement with reduced zinc and/or no beta-carotene works as well as the original supplement in reducing the risk of progression to advanced AMD."

    Find an AREDS2 Clinical Center.



    • Without treatment, patients with intermediate AMD had an 18% chance of progressing to advanced AMD in one or both eyes over 5 years.
    • Without treatment, patients with advanced AMD in one eye had a 43% chance of progressing to advanced AMD in the other eye.
    • With treatment, high risk patients decreased their risk of progressing to advanced AMD by 25% (in the case of advanced AMD in one eye, this decreased risk refers to the other eye).
    • With treatment, risk of moderate or severe vision loss was decreased by 19% over 5 years.
    • Treatment did not slow progression from early AMD to intermediate AMD.
    • There was no evidence that vision loss or disease progression was reversed in any treatment group.
    • Compared to placebo, addition of lutein/zeaxanthin and/or omega-3 fatty acids to the previous AREDS formulation showed no significant effect on AMD progression or visual acuity loss.
    • There was no effect of beta-carotene elimination or lower-dose zinc on progression to advanced AMD.
    • 2% of patients developed lung cancer in the beta-carotene group, versus less than 1% in the group without it (almost all cases were found in former smokers).
    • Addition of lutein and zeathanthin may have some effect on AMD progression in those populations in which the dietary intake of these nutrients is low.
      • There was, however, no trend with increasing intake.
      • Is an area that needs more investigation.

    FOR IMMEDIATE RELEASE -- MADISON, N.J. - Bausch + Lomb is conducting a voluntary recall of its PreserVision® Eye Vitamin AREDS 2 Formula with Omega 3 soft gels, only available within the United States.

Important Update on AREDS 2 Findings

If you order the item on this page, your order will be automatically upgraded to receive VisiVite AREDS 2 Select Formula, now with 40 mg daily zinc.