The patent (no EP2473065B1), entitled ‘a xanthophyll composition containing macular pigments and a process for its preparation’, covers the composition and method of preparation of Lutemax 2020, a xanthophyll complex made up of three macular pigments - lutein, RR-zeaxanthin and RS (meso)-zeaxanthin.
Indian firm OmniActive first filed this patent in September 2009 (priority date), coinciding with the launch of Lutemax 2020 at SupplySide West in 2009.
Almost seven years later, the patent for Lutemax 2020 has been granted and OmniActive is keen to drive sales of Lutemax 2020 in Europe.
“OmniActive’s focus is to grow the European market by differentiating Lutemax 2020 and demonstrating how it uniquely impacts eye, skin and brain health through our robust and ongoing clinical programme,” said Lynda Doyle, global vice president of marketing, OmniActive Health Technologies.
She confirmed Lutemax 2020 was globally available, with the US, Europe and Asia its primary markets.
“Lutemax 2020 is readily available in the European food/supplement market. The science on macular carotenoids is well established,” she said.
This is interesting because although in the US Lutemax has GRAS (Generally Recognised as Safe) status, required for the marketing of novel food ingredients, in Europe, the legality of meso-zeaxanthin under novel food regulation has not yet been confirmed. Some proponents have, however, speculated that it may not be necessary under EU law since it existed in the food chain before 1997.
Safety evidence stacking up
From OmniActive’s perspective, the patent also provides welcome support that RS-zeaxanthin is safe.
“This European patent further supports the importance and safety of all three macular carotenoids – lutein, RR-zeaxanthin and RS (meso)-zeaxanthin as well as OmniActive’s commitment to educate industry members, consumers, researchers and healthcare professionals about the important role macular carotenoids play in health – eye, skin and brain – through each stage of life,” said Doyle.
The science behind RS-zeaxanthin is still in its infancy. Unlike lutein and RR-zeaxanthin, which are found in the brain, breast milk and other tissues as well as the eye, RS-zeaxanthin is only concentrated in a very localised area of the macular in the eye. This has led some researchers to question whether there are safety issues associated with the uptake of RS-zeaxanthin in organs and body systems where it is not inherently present.
OmniActive insists that RS-zeaxanthin is not only safe, but critical for optimal eye health. “Lutemax 2020 contains all three macular carotenoids at the same 5:1 ratio as found in nature. Very few supplements contain all three macular carotenoids at significant levels and healthy eyes require more than just lutein and RR-zeaxanthin alone. Meso-zeaxanthin is a necessary component to support visual function and health and its deposition in the eye is highly specific – the centre of the macula,” said Doyle.