Eye health update: exploring the latest developments in the eye health market.

The connection between nutrition and eye health has been made and consumers and eye care professionals are really starting to "get it." Over the past several years much work has been done and a lot of ground gained on the part of researchers, suppliers and associations to get the word out regarding not only nutrition and eye health but also the fact that most degenerative eye diseases can be prevented. The real explosion in the eye health market came following publication of the Age-Related Eye Disease Study (AREDS), whose results pointed to key nutrients as having a role in the prevention of age-related macular degeneration (AMD). This study, referred to as a seminal work by most experts in the eye health field, opened the minds of many consumers as well as eye care professionals to the relationship between nutrition and eye health.

The AREDS results coupled with the rapid increase in aging Americans has brought increasing attention to eye health issues. Discussing this was Amy Cone, marketing director, Kemin Foods, Des Moines, IA, who said, "Vision starts changing for most people in their late 40's or early 50's and their consciousness of eye health seems to increase because they are seeing the eye doctor more frequently. A proactive eye doctor will routinely give them dilated eye exams, which are particularly important in the case of eye conditions such as AMD."

There are several eye diseases to watch out for, however, the most frequently discussed are AMD, cataracts and diabetic retinopathy (see Table 1). So far, most of the research has focused on nutrition's role in AMD, and to a lesser extent cataracts and diabetic retinopathy.

AMD specifically has been recognized as the leading cause of legal blindness in people age 50 and over in the Western world. In addition, according to a recent Duke study, the prevalence of AMD among U.S. residents age 65 and older increased from 5% to 27% between 1991 and 1999. Worldwide the statistics are even more staggering. It is estimated that 25 to 30 million people are afflicted with the disease, according to the AMD Alliance International, Toronto, Ontario, Canada, an advocacy group supporting global AMD consumer education, research and treatment.

In the case of diabetic retinopathy, the amount of consumers affected is also overwhelming, as the cases of diabetes have skyrocketed during the past decade. In the U.S. alone, according to Greg Edmunds, vice president--marketing, Charles Bowman Company, Holland, MI, 17 million people have been diagnosed with diabetes and this figure is growing exponentially every year. The Natural Marketing Institute (NMI), Harleysville, PA, reported in its Health & Wellness 2003 Trends report that over 41% of diabetics are treating vision problems compared to 26% of the general population. In other words, said Mr. Edmunds, 4.5 million diabetics are treating vision problems. "It is important to mention that when an individual is diagnosed with diabetes, there is a real risk of blindness. Unfortunately, there are little or no conventional therapies offered (pharmaceuticals) to treat this possible outcome," he said.

Exploring Recent Developments in Research: Beyond AREDS

The AREDS study, as mentioned previously, was the crowning achievement for the nutrition community, and is THE work that is referenced today when discussing nutrition and eye health. Revisiting the AREDS study, Lynda Doyle, director of marketing--new ingredients and business development, DSM Nutritional Products, Inc., Parsippany, NJ, said, "AREDS showed significant reduced risk of progression to advanced AMD and its associated vision loss in individuals with AMD, who were supplemented with vitamins C and E, beta-carotene, copper and zinc. AREDS has provided health professionals credibility to the role of nutrition in eye health." She added, "Since the October 2001 announcement of these results, the eye health market has exploded. In addition to the Ocuvite Preservision, the product used in AREDS, there have been numerous products formulated based on the study."

Discussing how the study affected the eye care community, Ms. Cone said, "The interesting thing about AREDS was the way it impacted the eye health community. Prior to the study there was a lot skepticism, particularly among ophthalmologists. The AREDS study really allowed some doors to be opened in terms of the receptivity level to the concept of nutrition and eye health."

Not only did AREDS create a forum for discussion for time relationship between nutrition and eye health, it also allowed other ingredients beyond the AREDS nutrients to be explored as well. One such ingredient was lutein, a carotenoid that was left out of time AREDS trial because it was not commercially available at the time. To bolster lutein's position in eye health several studies were conducted in the interim. Of particular interest is the latest study, the Lutein Antioxidant Supplementation Trial (LAST), which was completed last year by Dr. Stuart Richer. The results of the study were presented at the 2002 Association for Research in Vision and Ophthalmology (ARVO) meeting. In this double-blind, placebo-controlled trial, 90 AMD patients were supplemented daily with 10 mg of lutein, 10 mg of lutein plus a mixed antioxidant formula of placebo for 12 months. Patients ingesting the lutein supplement experienced significant improvements in several objective measurements of visual function, including glare recovery, contrast sensitivity and visual acuity vs. placebo. Patients also experienced a 50% increase in macular pigment density relative to those on placebo. Slightly better results were observed in those subjects consuming the combination supplement. Kemin is eagerly awaiting publication of these results and while it regards the study findings to date as encouraging, it does not consider the study to be conclusive and thinks the results call for a larger trial to obtain a larger universe of data--a wish that may soon come true.

According to Ms. Cone, "We have heard from various sources that the National Institutes of Health (NIH) is very seriously considering and possibly already taking action toward an AREDS plus lutein national clinical trial. Ultimately this would shore up among the medical community lutein's role in eye health."

In terms of cataracts, Ms Doyle said the research continues to point toward vitamin C and E. "Several recent studies have linked time antioxidant vitamins C and E with a reduced risk of cataracts. The Nutrition and Vision Project, an analysis of the Second National Health and Nutrition Examination Survey, the five-year follow-up to the Beaver Dam Eye Study, and the Roche European-American Cataract Trial (REACT) have all indicated that people with higher intakes and/or better biological measures of the antioxidant vitamins C and E have a reduced risk of age-related cataracts."

Beyond vitamins C and E, Kemin feels lutein may also have a role in the prevention of cataracts. "In the last several years more attention has been paid to carotenoids, specifically lutein and zeaxanthin. The reason for this is because of the 600 carotenoids found in nature, and of the 20 found in human serum, only lutein and zeaxanthin are found in the lens," the company said. While the research on lutein and zeaxanthin with respect to cataracts remains preliminary the findings are encouraging and call for more work to be undertaken.

What's New on the Eye Health Ingredient Front?

Beyond time mainstay ingredients in the eye health market are those that remain wedged between the descriptors "established" and "up-and-coming." While most of these ingredients do not have the luxury of being involved in studies on the scale of the AREDS trial, they nonetheless remain interesting possibilities that warrant further investigation. What follows are the latest developments on lutein, zeaxanthin, omega 3 fatty acids, blueberries, bilberries and Pycnogenol[R].

Lutein & Zeaxanthin

Lutein is an obvious front runner in the eye health arena due to research that has been piling up over the last several years. It is this research that has made the ingredient such an exciting, interesting prospect in the eye health market. Despite being left out of the AREDS study, research carried out by a host of experts in the field has propelled lutein to the front lines of science-based ingredients.

Lutein, along with zeaxanthin, is highly concentrated in the macula, a small area of the retina responsible for central vision and high visual acuity. The macular pigment is the yellow pigment within the macula that protects this tissue from the damaging photo-oxidative effects of blue light, and is comprised entirely of lutein and zeaxanthin.

Commenting of the function of lutein and zeaxanthin was Leo Cullen, executive vice president, Buckton Scott Nutrition, Fairfield, NJ. "Although exactly how lutein and zeaxanthin function in the eye is not fully understood, researches propose that their health benefits have to do with their antioxidant ability and their absorption of near-to-blue ultra-violet (UV) light," he said, adding, "A growing body of evidence from epidemiological and experimental studies has implicated a role for the macular pigment in the protection against cataract and AMD."

Discussing recent developments with both lutein and zeaxanthin, Ms. Cone said, "Zeaxanthin is a stereoisomer, which means it is a very closely related compound to lutein. In fact, they occur together in nature and are often measured together." She added, "There is some exciting new research that shows that the lutein that one takes in is converted in the retina to zeaxanthin. Researchers are showing that people take in lutein in greater amounts than zeaxanthin in the diet and it is taken up and converted in situ to the form that best suits the biological need in the particular area of the retina."

Omega 3 Fatty Acids

Also finding a place in the maintenance of eye health and the prevention of eye diseases are omega 3 fatty acids. Although the research is in its infancy, experts remain optimistic. According to Pronova Biocare, Oslo, Norway, the role of DHA in eye health relates to the correlation of low incidence of AMD in populations with high intakes of fish. According to a study published in the Archives of Ophthalmology in 2000, 3654 individuals older than 49 years were examined in order to reveal signs of clinical AMD. At the same time, dietary questionnaires were collected to correlate the intake of certain nutrients with the occurrence of the disease. Two hundred and twenty-nine participants were found to have clinical signs of AMD in different stages of development. Correlation with the different dietary intake of nutrients among the participants in the study showed that a regular intake of fish (1-3 fish meals per month) prevented the development of AMD, while a high intake of saturated fat and cholesterol predisposed to a higher risk of contracting the disease.

Further, in the Nurses' Health Study, which included 42,743 women and 29,746 men followed for almost 10 years, 567 developed AMD. Fat intake in the study was assessed by a food frequency questionnaire. As in the study mentioned in the previous paragraph, fat intake was positively correlated with increased risk of getting the disease, while a high intake of fish was associated with a 35% lower risk compared to those who only seldom had fish meals.

Earlier this year, according to Pronova, a scientific meeting was arranged in Paris, France, to discuss the scientific basis for using DHA-enriched omega 3 supplements for the prevention and treatment of AMD. The company said there was a general agreement that the scientific basis for using DHA was present and preparations are ongoing for a controlled clinical trial in France using a recently launched DHA-based nutritional supplement.

Moving away from AMD, omega 3's have also been connected to dry eye. In the largest study to date examining the relationship of diet to dry eye, researchers at Harvard Medical School have discovered that eating more of the omega 3's in flaxseed and fish can help prevent and relieve the dry-eye symptoms experienced by some 59 million Americans. The study, presented at the Annual Meeting of the Association for Research and Ophthalmology, involved 32,470 women who participated in the Women's Health Study at Harvard Medical School. The study showed conclusively that in many patients dry eye is a dietary deficiency of the omega 3 oils found in flaxseed and fish. Omega 3's, researchers said, are the essential fatty acids that eyes, lids and tear film need to function best, but that the body cannot produce.

Bilberries & Blueberries

Bilberries and their American cousins, blueberries, have been prevalent in the eye health arena for some time. However, it is bilberry that has hogged the spotlight when it comes to research. It is the frequently referenced use of bilberries by World War II fighter pilots that prompted a deeper examination of the botanical and has been the impetus behind almost three decades of clinical work. More recently the work and emphasis has focused on diabetic retinopathy.

One such product that has been available in Europe by prescription for diabetic retinopathy and other veinous disorders is Difrarel[R], which is manufactured by Laboratoires Leurquin Mediolanum, Neuilly, France. Over 60 studies have been performed on Catocyanic Complex[R], which is the active component in Difrarel, or on Difrarel itself. Charles Bowman's Mr. Edmunds said few companies have fully understood bilberry's function in eye health because until now, Catocyanic Complex had not been available on the U.S. market. What makes Leurquin's bilberry ingredient so unique is that unlike any other product on the market, it is produced through a fermentation process, which, according to the company, allows it to preserve the nutritive and active properties of the compound.

On the blueberry front, Tom Payne, consultant to the U.S. Highbush Blueberry Council, Folsom, CA, said a lot of the development of blueberries in the U.S. has been based on eye health markets overseas. "What happened was Japan came to the forefront and made an association between bilberries/blueberries and eye health," he said. "They didn't really discriminate between the two--bilberries and blueberries--because they felt it was the anthocyanins that were responsible for the positive effects on eye health."

Of late, Mr. Payne said, research out of Japan has made an association between blueberries and eye strain. "Quite a bit of the trend now hasn't only been eye health but also fighting against eye strain," he said. "Some of the products coming out of Asia contain names such as 'Tired Eyes/claiming that bilberries/blueberries are not only good for vision but also for those that sit in front of computers all day, for example."

Comparing awareness levels, Mr. Payne pointed out that overseas 85-90% of consumers are aware of the relationship of blueberries to eye health, while in the U.S., the penetration hovers around 15-20% awareness.

In recent developments, Mr. Payne said the U.S. Highbush Blueberry Council recently developed an eye health energy bar for the U.S. military. "'We started by investigating a number of the ocular formulas on the market and put some of the most frequently used ingredients into this bar," he said. "It was tested by the military and they gave it a perfect 10." Mr. Payne went on to say that the military really liked the concept of soldiers being able to eat products that are good for specific functions, such as eye health.

Pycnogenol[R]

Horphag Research, Geneva, Switzerland, has been actively involved on the eye health front with its Pycnogenol[R] product. The company claims it has conducted a couple of studies with more than 1000 subjects to show that Pycnogenol[R] is helpful in maintaining the integrity of the tiny capillaries in the eye to stop the progression of diabetic retinopathy. Dr. Frank Schonlau, a scientist with Horphag Research, said, "In diabetes, the elevated glucose in the bloodstream alters the proteins making up the capillary walls allowing them to get brittle causing blood to then seep out from the capillaries into the retina. While the retina fills with blood, the blood supply is cut off and thus the cells are not properly supplied with oxygen and then die off." He continued, "Many people don't really understand that those things that damage the light sensing cells in the eye are irreversible. This is not like what happens, for instance, when you cut yourself and the neighboring cells divide and fill in the gap until the wound is healed. If these light sensing cells die off, they are gone for good."

Education and Awareness

Awareness of eye health in general and the nutraceuticals that can play a role has grown significantly, especially among consumers over 50. But should there be a wider audience involved in the nutrition and eye health discussion? The short answer is yes. However, as Kemin's Ms. Cone pointed out, there are going to be several challenges in addressing younger age groups. "Different age groups have lower levels of receptivity to prevention messages because of what is going on in their lives and what are their immediate concerns. For the younger age brackets, they tend to not be as focused on themselves as they are on others in their life--for example, with those raising children," she said, adding, "However, with respect to nutrition we know that people are not eating according to the food pyramid across the age spectrum and it is certainly thought that the earlier consumers have appropriate nutrition, the better off they are going to be."

Frank Assumma, director of marketing, Natural Health Science, Hillside, NJ, also said penetrating younger generations with prevention messages will be difficult. "The preventative approach to health is very difficult to communicate yet is the easiest to implement," he said. "Selling prevention is similar to getting people to believe in saving for retirement at a young age. For younger age groups, their question is 'why now?'" He continued, "You can't make up for 20 years of not saving your money and in the same way, you cannot make up for 20 years of not taking care of yourself. We need to start talking about and promoting eye health as early as possible. The earlier that people start to care about this the faster the degradation will cease."

DSM's Ms. Doyle pointed out that only 19% of adults 40 and older are taking a vitamin of a dietary supplement for eye health, according to data from the "2003 Gallup Study of Eye Health." Of particular interest, she said, is the more detailed data that only 15% of 40-49 year-olds are taking vitamins or dietary supplements for eye health, compared to 23% of those 65 and older. "This points to a key issue in the eye health market--educating 'younger' consumers about the importance of prevention when it comes to eye health," she said.

However, Ms. Doyle said that consumer education alone isn't sufficient in driving the eye health supplement market. She said it is also critical to provide strong scientific support to health professionals, who play key roles in consumer health education. In this vein, DSM Nutritional Products, Inc. has provided that scientific support and health professional education through the Vitamin Nutrition Information Service (VNIS). The VNIS was founded in 1979 and is supported by DSM Nutritional Products, Inc. as a source of accurate and credible vitamin information for health professionals, educators and communicators. The VNIS monitors and disseminates vitamin research, sponsors professional symposia on current vitamin topics and generates materials to educate professionals about the roles of vitamins in health.

Another example of how DSM is working to build the eye health category is through Eye on Nutrition, which is a user-friendly tool that health professionals can use with their patients to assess their current nutrient status and identify behaviors that may help preserve eye health. Eye on Nutrition was created by the VNIS in conjunction with the American Optometric Association, St. Louis, MO, as part of an educational partnership, and is organized into three parts. The first section asks specific eye health history questions (i.e., Has anyone in your family been diagnosed with AMD?), as well as questions regarding certain behaviors that affect eye health (i.e., Do you smoke?). The user will then be asked whether they eat certain foods, how much and how often. After completing the test, the user receives an evaluation of their eye health history and behaviors as well as an analysis of their diet. Lastly, the user receives personalized tips on how they can help protect their eyes from developing cataracts and AMD.

Most experts believe that AREDS made the discussion of nutrition and eye health possible among eye care professionals. Going forward this will be a key influencer group in getting nutrition and eye health messages out to consumers.

Table I
Definitions and Visuals of Various Eye Diseases

(This information was compiled from a variety of sources. The images
showing eye disease simulations were provided courtesy of the National
Eye Institute, which is part of the National Institutes of Health
(NIH), Bethesda, MD.)

Age-Related Macular Degeneration (AMD): AMD is an eye disease that
Causes loss of central vision, leaving only peripheral, of side, vision
intact. It usually does not lead to total blindness, The disease can
manifest itself in the dry or wet form. The dry form occurs when drusen
collects beneath the macula causing it to thin and dry out. Dry AMD
accounts for 85-90% of all AMD cases. The wet form of AMD is caused by
the growth of choroidal neovascular vessels under the macula. The leaky
blood vessels cause distortion and Loss of central vision. Although wet
AMD accounts 10-15% of all AMD cases, it creates 90% of the severe
vision Loss associated with AMD, (AMD Alliance International, Toronto.
Ontario, Canada)

Cataract: A cataract is a clouding of all or part of the normally clear
lens within the eye, which results in blurred or distorted vision.
Cataracts are most often found in persons over age 55, but they are
also occasionally found in younger people. No one knows exactly what
causes cataracts, but it is known that a chemical change occurs within
the eye to cause the lens to become cloudy. This may be due to
advancing age, heredity, injury or disease. Excessive exposure to
ultraviolet radiation in sunlight, cigarette smoking or the use of
certain medications are also risk factors for the development of
cataracts. Although cataracts develop without pain or discomfort, there
are some indications that a cataract may be forming. These include
blurred or hazy vision, the appearance of spots in front of the eyes,
increased sensitivity to glare or the feeling of having a film over the
eyes. A temporary improvement in near vision may also indicate
formation of a cataract. (American Optometric Association, St. Louis,
MO)

Diabetic Retinopathy: Vision impairment is a frequent complication of
diabetes, for both type I and type 2. The major cause of blindness in
people with diabetes is diabetic retinopathy. Diabetic retinopathy is
a term used for all the abnormalities of the small blood vessels of the
retina caused by diabetes, such as weakening of blood vessel walls
or leakage from blood vessels. Retinopathy progresses from
non-proliferative or background retinopathy to proliferative
retinopathy. Nearly all patients who have type I diabetes for about 20
years will have evidence of diabetic retinopathy, while up to 21% of
people with type 2 diabetes have retinopathy when they are first
diagnosed with diabetes, and most will eventually develop some degree
of retinopathy. In the U.S., diabetes is responsible for 8% of legal
blindness, making it the leading cause of new cases of blindness in
adults 20-74 years of age. (American Diabetes Association, Alexandria,
VA)