Phase III trial shows FloraGlo lutein (Kemin) fails to protect against AMD

A multicenter, randomized clinical trial that included people at high risk for progression to advanced Age-related Macular Degeneration (AMD), shows that adding lutein and zeaxanthin, and the omega-3 fatty acids DHA and EPA, as found in FloraGlo lutein from Kemin and DSM, to a formulation of antioxidant vitamins and minerals (so-called AREDS formulation) that has shown effectiveness in reducing risk, did not further reduce risk of progression to advanced AMD. AREDS2, a Phase III study was conducted in 2006-2012, enrolling 4,203 participants 50 to 85 years of age at risk for progression to advanced AMD. A secondary goal was to evaluate the effect of eliminating beta carotene and lowering zinc doses.

The probabilities of progression to advanced AMD by 5 years were 31 percent for placebo, 29 percent for lutein + zeaxanthin, 31 percent for DHA + EPA, and 30 percent for lutein + zeaxanthin and DHA + EPA. In the primary analyses, comparisons with placebo demonstrated no statistically significant reductions in progression to advanced AMD. See: "Lutein + Zeaxanthin and Omega-3 Fatty Acids for Age-Related Macular Degeneration. The Age-Related Eye Disease Study 2 (AREDS2) Randomized Clinical Trial" The AREDS2 Research Group. JAMA. 2013:1-11. doi:10.1001/jama.2013.4997