National Institutes of Health

NIH AREDS Lead to PreserVision Vitamins

Eye vitamins labeled as AREDS or AREDS2 refer to the results of the Age-Related Eye Disease Study, a major clinical trial sponsored by the National Eye Institute (NEI) at the National Institutes of Health.  A number of manufacturers offer nutritional supplements based on these studies.

These studies reported that high levels of antioxidants and zinc could slow the progress of AMD. While the original AREDS formulation contained vitamin C, vitamin E, beta-carotene, zinc, and copper, in 2013, NEI reported the results of the follow-up AREDS2 study, where researchers tried adding omega-3 fatty acids and substituting lutein and zeaxanthin for beta-carotene (which prior studies had associated with an increased risk of lung cancer in smokers). The study found that while omega-3 fatty acids had no effect on the formulation, lutein and zeaxanthin together appeared to be a safe and effective alternative to beta-carotene. The AREDS2 formula now contains vitamin C, vitamin E, copper, lutein, zeaxanthin, and a lower amount of zinc. The AREDS formula that incorporates these vitamins isn’t a cure for AMD; however, it is extremely beneficial to anyone who has been diagnosed with intermediate or advanced AMD.

The AREDS and AREDS2 vitamins are neither a treatment nor a cure for macular degeneration. The studies showed that the formulations were most beneficial for people with:

• Intermediate age-related macular degeneration in one or both eyes, or
• Advanced age-related macular degeneration in one eye, but not the other eye

People with early stage age-related macular degeneration did not benefit from taking either AREDS formulation. AREDS does not prevent AMD from starting.

Researchers studied the following doses in AREDS and AREDS2:

• 500 milligrams (mg) of vitamin C
• 400 international units (IU) of vitamin E
• 80 mg zinc as zinc oxide (25 mg in AREDS2)
• 2 mg copper as cupric oxide
• 15 mg beta-carotene (AREDS), OR 10 mg lutein & 2 mg zeaxanthin (AREDS2)

People who smoke or have a history of smoking should avoid taking beta-carotene, also labeled as vitamin A. The AREDS2 formula with lutein and zeaxanthin is an alternative for people with a history of smoking. Lutein and zeaxanthin provide the eye the same benefits as beta-carotene without the health risks.

Before taking AREDS or AREDS2, talk to your primary care doctors and eye care professionals. They will help you determine if AREDS is best for you.

Meningococcal meningitis, a bacterial infection of the brain that sweeps across sub-Saharan Africa in an area called the “meningitis belt,” is now losing its power to inflict illness and death. Scientists and technology transfer officers from the Food and Drug Administration (FDA), along with technology transfer officers from the National Institutes of Health (NIH), made a critical contribution by developing and transferring the technology needed to manufacture a vaccine against this terrible disease and at an affordable cost for African nations like Burkina Faso, Chad, Ethiopia, and Niger. Meningitis can be prevented with vaccination, but the technology is complex and generally beyond the capacity of scientists in most developing countries.

Under a novel partnership mechanism organized by the international nonprofit PATH (Program for Appropriate Technology in Health), NIH licensed a conjugate vaccine technology developed by FDA Drs. Che-Hung Robert Lee and Carl Frasch to PATH, which worked with the Serum Institute of India, which agreed to produce the vaccine cheaply in exchange for technical know-how. The collaboration agreement was described in SciDev.net as an "intriguing model" of vaccine development in developing countries, in which a vaccine with specific characteristics tailored to a particular population is developed at a modest cost and provisions to ensure sustainable access are built in from the start.

The new vaccine, MenAfriVac, was approved by India in December 2009 for export to Africa. In June 2010, the World Health Organization had prequalified the vaccine for use in global immunization programs. By the end of 2011, an estimated 55 million people had been vaccinated with MenAfriVac at a cost of only 40 cents per dose. In 2012, a low-cost meningitis vaccine designed for use in sub-Saharan Africa without refrigeration or cold-chain custody was launched, with sales of 100 million doses.

The contribution of both the FDA and the NIH to a major health care project in Africa also underscores the recognition by both agencies that infectious diseases know no borders. Protecting human health globally is linked to the FDA’s and NIH’s core mission of protecting human health in the United States.