NMA: Nonprescription Medicines Academy

No Additional Eye Health Benefit from Carotenoids, Omega-3 Fatty Acids

May 29th, 2013

The Age-Related Eye Disease Study (AREDS), which was led by the National Eye Institute and concluded in 2001, demonstrated that daily supplementation with high doses of vitamins C and E, beta-carotene, zinc, and copper (the “AREDS formulation”) reduced the risk of developing advanced age-related macular degeneration (AMD). In the recently concluded Age-Related Eye Disease Study 2 (AREDS2), adding the carotenoids lutein plus zeaxanthin or the omega-3 long-chain polyunsaturated fatty acids docosahexaenoic acid (DHA) plus eicosapentaenoic acid (EPA) to the AREDS formulation did not further reduce risk of progression to advanced AMD.

AREDS2 was a 5-year, multicenter, randomized, double-masked, placebo-controlled phase 3 study with a 2 × 2 factorial design. A total of 4,203 participants 50 to 85 years of age who were at risk for progression to advanced AMD were randomized to receive lutein (10 mg) + zeaxanthin (2 mg), DHA (350 mg) + EPA (650 mg), lutein + zeaxanthin and DHA + EPA, or placebo in addition to the original AREDS formulation. Progression to advanced AMD was established by examination of retina photographs or treatment for advanced AMD.

Comparison with placebo in the primary analyses demonstrated no significant overall effect of lutein + zeaxanthin, DHA + EPA, or both on progression to advanced AMD or changes in visual acuity. However, the study results did support using lutein + zeaxanthin as a carotenoid substitute in the AREDS formulation for former smokers, given a possible association between beta-carotene use and the risk of lung cancer among those patients.

JAMA. 2013;309(19):2005-15. Epub 2013 May 5.