In a National Eye Institute press release1 issued on May 5, 2013, with simultaneous online publication in JAMA,2 the results from the second phase of the Age-Related Eye Disease Study 2 (AREDS2) were announced. This press release was titled “NIH study provides clarity on supplements for protection against blinding eye disease,” and indeed in its first paragraph, the primary outcome was clearly stated: “The plant-derived antioxidants lutein and zeaxanthin also had no overall effect on [age-related macular degeneration (AMD)] when added to the combination; however, they were safer than the related antioxidant beta-carotene.” This study provided us with a striking example of a major clinical trial in which the primary outcome was negative, but yet its broader findings prompted substantial changes in the formulation of so-called eye vitamins that constitute a major market presence and are likely recommended by most eye care practitioners for a patient they determine to be at risk for developing neovascular AMD. The ability of companies to market their eye vitamins as providing an exact match to the AREDS2 formula is evidently important because we encounter such statements in venues ranging from our professional journals to television commercials. While some might say that the train has long since left the station, the purpose of this editorial is to critically evaluate the evidence underlying formulation changes that are under way or have already taken place.
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