Eye health supplements: AREDS2 formulas and how to build one

What the AREDS and AREDS2 studies used

The National Eye Institute's AREDS/AREDS2 frequently asked questions set out the two formulas:

Nutrient	AREDS	AREDS2
Vitamin C	500 mg	500 mg
Vitamin E	400 IU	400 IU
Beta-carotene	15 mg	none
Lutein	none	10 mg
Zeaxanthin	none	2 mg
Zinc	80 mg	80 mg
Copper (cupric oxide)	2 mg	2 mg

AREDS2 replaced beta-carotene with lutein and zeaxanthin. The NEI explains why: among former smokers in AREDS2, lung cancer was found in 2% of those taking beta-carotene against 0.9% of those not taking it, while lutein and zeaxanthin "have not been associated with increased cancer risk". The NEI says the original AREDS formula is "Not recommended for current or former smokers."

AREDS2 also tested adding omega-3 fatty acids, which had no additional overall effect on the risk of advanced AMD, and a lower zinc dose. With no placebo group in AREDS2, participants were assigned to 80 mg or a modified formula such as 25 mg zinc, and investigators found no difference between the two doses.

What the studies found, and what they didn't

As the NEI puts it, the formulas benefited people with intermediate or late AMD, with "no benefit for people with early AMD or for people who do not have AMD". AREDS reduced the risk of advanced AMD by about 25% over five years. In AREDS2, the formula with lutein and zeaxanthin in place of beta-carotene was linked to an 18% lower risk of progressing to advanced AMD than the original formula. The NEI is clear that "Nutritional supplements cannot prevent AMD", and that the formulas had no effect on cataract.

These are the study's findings, about a disease that an eye-care professional diagnoses and manages. They aren't claims a supplement can make for itself.

The claims a listed eye-health product can make

A listed medicine can only carry indications from the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025. Among its eye indications are:

• "Maintain/support eye health"
• "Helps maintain/support eye macula health"
• "Helps maintain/support eye retina health"
• "Maintain/support healthy eyesight/vision"
• "Maintain/support healthy eye function"
• "Decrease/reduce/relieve eye strain"
• "Aids/assists eye adaption to variations in light intensity/night vision"

The sponsor holds the evidence for each one, and the label can't imply the product treats a serious form of a disease, or prevents or cures one (permitted indications). So a claim that the product treats, slows or prevents AMD falls outside what a listed medicine can say, and a claim that refers to a serious form of a disease is a restricted representation, which needs the TGA's approval. How a brand refers to the studies in its marketing is an advertising question, covered in our TGA advertising guide.

Formulating an eye-health product

• Dose and form. The formula follows the doses the studies used, and each ingredient's form and dose must fit the conditions in the Permissible Ingredients Determination (permissible ingredients). In our AREDS2 work, the formula was updated to the AREDS2 vitamin E level before it was built.
• The format. One eye-health formula in our records kept failing in encapsulation because the ingredient mix was too wet, and hand-filling would have added one to two months. We moved it to a direct-compression tablet (capsules, tablets and softgels).
• Stability. The shelf life rests on stability data for the product in its pack. The tablet's stability protocol was designed to support a three-year expiry, and the AREDS2 formula has a 24-month stability program (stability testing).
• Packs. The AREDS2 formula ships in a 60-count pack and a trial pack, both made in each run (sample and trial packs).

From our records

• An AREDS2 eye-health formula: a premium formula for an established Australian health brand, built on the AREDS2 nutrient levels, with vitamin E brought to the AREDS2 level before build. A 60-count pack and a trial pack, a certification to reach more customers, and a 24-month stability program. Design to production order in under seven weeks, reordered a year later with the certification renewed.
• An eye-health tablet rescued from encapsulation: an established natural health company's formula moved to a direct-compression tablet, with a stability protocol for a three-year expiry. Shipped in 2024. Across the relationship we developed and quoted nine products, and a fish oil and a krill oil capsule are also in production.