Individuals with damaged or declining vision are a growing, international demographic. “According to estimates made by the World Health Organization in 2014, 285 million people worldwide have some type of visual impairment,” noted Lynda Doyle, vice president of global marketing, OmniActive Health Technologies, Morristown, NJ. “With so many people affected, it is no wonder the global eye health market—comprising of OTC (over-the-counter) eye care and eye health supplements—is worth nearly $5 billion, growing a hardy 15% from 2008 to 2013 (Euromonitor, 2014).” Moreover, Ms. Doyle cited data from Innova Market Research that found a variety of new product introductions in the eye health supplement category contributed 3.4% of the total supplements introduced to the market in 2014.
Growing consumer interest plus the proliferation of sound clinical research backing various ingredients for eye health will continue to propel this market forward.
A growing aging population is the most apparent factor driving demand for eye health products, according to Golan Raz, vice president of the health and nutrition division at LycoRed, South Orange, NJ. Specifically, he stated Age Related Eye Disease (ARED) is a growing international concern. “The risk accumulates as we age, however, especially after the age of 50 the risk for ARED grows substantially. At the age of 75 years old, 25% of the population suffers from age-related macular degeneration (AMD).”
AMD is the leading cause of visual impairment and blindness in older Americans, according to the National Eye Institute (NEI). This form of eye disease results in yellowish deposits in the retina, which in time can cause distortion and gradual blurring of vision. Larger deposits and leaking blood vessels in the retina caused by AMD may impair the ability to see straight ahead over time, only leaving peripheral vision intact.
Jeffrey Anshel, OD, FAAO, founder of Corporate Vision Consulting, Encinitas, CA, pointed to a survey conducted by the Ocular Nutrition Society, which found that Baby Boomers were expressly aware of the importance of nutrition in maintaining eye health.
“Since we tend to lose our pigments with age (think gray hair), our eyes also lose these pigments and make them more susceptible to oxidation from free radicals,” he explained.
Ms. Doyle suggested eye health supplements are amassing a following of varying ages. “Eye health continues to be a top consumer health concern around the world in all age categories, and it is emerging as a top health concern for kids here in the U.S. (HealthFocus International, 2012). And it’s not just about age-related eye disease anymore—there are many dimensions to consumer concerns around eye health, including not being able to see as well as one used to, eyestrain from too much computer use, poor night vision and not being able to see things close up or far away. Concerns about eye health are far-reaching across all ages.”
Daily stresses to the eyes presented by phones, computers, televisions and tablets pose a new and growing threat to eye health. The blue light emitted from such devices is damaging to the retina over time, explained Ms. Doyle, and can seriously impact visual acuity.
Janice Brown, technical support with AstaReal, Inc., Burlington, NJ, added that the prevalence of digital devices used in work and leisure has led to an increased incidence of Computer Vision Syndrome (also known as Digital Eye Strain), with symptoms including eye strain, headaches, blurred vision, dry eyes, and neck and shoulder pain. She warned that many of these symptoms may be temporary, but some people may experience impaired vision long-term, and in some cases blurred distance vision.
“These devices are being used by younger individuals every year, creating a lifetime of assault on our eyes,” Ms. Doyle cautioned. “In addition, obesity, smoking, exposure to sun and environmental pollutants, not to mention the natural oxidative stress our bodies experience as we age, are all risk factors in visual performance and eye health.”
In an attempt to better educate the public on ways to project their sight, OmniActive Health Technologies launched the Lutein for Every Age campaign three years ago, to help individuals understand how they can take a proactive approach to maintaining vision over a lifetime through supplementation, healthy diet and lifestyle choices.
“This award-winning campaign also helps educate consumers about the importance of getting beneficial amounts of lutein and zeaxanthin isomers per day, which can be difficult through just diet alone,” Ms. Doyle explained. “Even individuals eating the government recommended nine servings of fruits and vegetables per day are only getting around 6 mg of lutein through their diet, far below beneficial levels. Supplementation with the macular carotenoids is critical in order to maintain proper eye health over a lifetime.”
The high incidence of diabetes worldwide is also impacting consumer interest in the eye health market. The Centers for Disease Control and Prevention (CDC) reported that diabetes (type 1 and type 2) affects more than 29 million people in the U.S., and is the leading cause of new blindness among those ages 20-74. The leading cause of blindness for American adults is diabetic retinopathy (DR), which causes damage to the blood vessels of the retina. In 2008, 33% of diabetic adults age 40 and up had some form of DR.
Sébastien Bornet, vice president of global sales and marketing at Horphag Research, Geneva, Switzerland, stressed that diabetics and those suffering from retinopathy should pay close attention to eye health, citing research published in the Journal of Ocular Pharmacology and Therapeutics that revealed the company’s French maritime pine bark extract could benefit such conditions. According to a 2009 study, two months of supplementing with 150 mg of Pycnogenol daily benefited microcirculation, retinal edema and visual acuity in the early stages of diabetic retinopathy, Mr. Bornet said.
Among the many nutritional components available to support eye health, formulas utilizing carotenoids are among the most popular and effective.
Data from MarketsandMarkets predicted that sales for carotenoids would continue to grow significantly in the coming years. In 2013, the research firm said these ingredients earned approximately $1.16 billion, and predicted they will grow at a CAGR of 3.5% from 2014 to reach $1.42 billion by 2019.
Perhaps the most significant research contributing to the prominence of these nutrients is NEI’s Age-Related Eye Disease Study (AREDS). Published in 2001 in the Archives of Ophthalmology (now JAMA Ophthalmology), the AREDS 1 trial found that high levels of vitamin C, vitamin E, beta-carotene and zinc reduced the risk of AMD and associated vision loss.
In 2013, NEI completed the AREDS 2 study, which examined if omega-3 fatty acids, along with antioxidants lutein and zeaxanthin, would have similar effects. Results found the new combination did not further reduce the risk of progression to advanced AMD. However, research did determine that lutein and zeaxanthin could provide a safe and effective alternative to beta-carotene, which was associated with risk of lung cancer in smokers in the AREDS 1 study.
LycoRed’s Mr. Raz commented that the AREDS 1 and 2 trials reaffirmed lutein’s role as an essential nutrient in the prevention of age-related eye disease. He added that lycopene also plays an important role in the functionality of lutein and suggested the “combination of these two synergistic carotenoids is going to be popular in the coming years.” Lycopene is a carotenoid that imparts the red pigment in tomatoes.
Mr. Raz continued, “It was found that people who suffer from age-related eye disease are more likely to have a lower blood level of lycopene [Clinica Chimica Acta, 2005]. The scientific thinking is that lycopene is taking a role in the protection of lutein while being absorbed. This scientific theory suggests that supplementation of both lutein and lycopene can improve prevention as the high level of lycopene will help lutein to reach its destination: the eye.”
Lutein and zeaxanthin are two of the most studied eye health ingredients on the market.
Clinical research published in the British Journal of Ophthalmology in 2015 found that supplementation with lutein and/or zeaxanthin increased macular pigment optical density (MPOD) in patients with early AMD. In addition, lutein was found to benefit retinal sensitivity.
The randomized, double-blind, placebo-controlled trial included 112 patients with early AMD. They were randomly assigned to take 10 mg lutein, 20 mg lutein, lutein (10 mg)+zeaxanthin (10 mg), or placebo daily for 2 years.
MPOD progressively increased after supplementation with lutein/zeaxanthin, while no significant change was observed in the placebo group. The most significant increase from baseline was found in the 20 mg lutein group after the first 48 weeks, while, at 2 years, MPOD in the 10 and 20 mg lutein groups were comparable.
The researchers concluded that macular carotenoids can augment MP and improve visual function in patients with early AMD, however more research is needed.
“Lutein and zeaxanthin still maintain the ‘leadership’ roles for eye health,” asserted Dr. Anshel. “They accumulate specifically in the central part of the retina (where we get our 20/20 vision from) and serve to filter high intensity light that might harm the sensitive cells of the retina.”
OmniActive’s Ms. Doyle further stressed the power of lutein and zeaxanthin, saying these “potent antioxidants protect against oxidative stress in neural tissue, especially in the eyes and brain. Lutein and the zeaxanthin isomers can neutralize most free radicals—including singlet oxygen, superoxide, hydroxyl and peroxynitrite radicals—and also activate antioxidant enzymes. These xanthophylls differ in their antioxidant activity, and complement each other especially in the macula.”
She referenced a body of compelling clinical research, which has demonstrated that long-term carotenoid supplementation may assist in healthy eyesight, visual performance and acuity, as well as support glare and contrast sensitively, vision in dim light and chromatic blur.
OmniActive offers a range of macular carotenoids including: Lutemax 2020 lutein with enhanced levels of zeaxanthin isomers; Lutemax Free lutein and lutein esters; and OmniXan RR-Zeaxanthin from natural paprika. Ms. Doyle noted the “Lutemax range of products are produced under a fully integrated supply chain process that starts with the cultivation of marigold flowers and continues through the extraction and manufacturing of beadlets, oils and powders for superior quality control.”
Mr. Raz suggested potent carotenoids like lutein and zeaxanthin are exceptionally useful in protecting eyes from the damaging light coming from phones, TVs and computer screens. These ingredients “filter harmful high-energy blue wavelengths of light and by that can reduce the risk for age-related eye diseases,” he said. “Lutein and zeaxanthin are known as powerful antioxidants and while present in the eye, can reduce the level of free radicals and prevent oxidation. This activity is helping to protect healthy cells and improve eye health.”
LycoRed recently began a pre-clinical program examining a new carotenoid composition known as Lyc-O-Vision. The formula includes lutein from marigolds, whole-tomato extract that naturally contains lycopene, rosemary extract and natural beta-carotene. Mr. Raz said the first stage in the company’s exploration is evaluating its effectiveness with cells taken from age-related eye disease patients.
While plenty of research has demonstrated the effects of lutein and zeaxanthin in patients with AMD, astaxanthin is now emerging as a carotenoid that can support eye health. AstaReal has “conducted studies to show that AstaReal astaxanthin works directly on the ciliary body (muscle in the eye), which becomes fatigued after prolonged use of digital devices,” commented Ms. Brown. “The ciliary body has three functions: accommodation, aqueous humor production and maintenance of the lens zonules. Our studies have shown astaxanthin to improve focus rates in patients suffering with CVS [Computer Vision Syndrome] symptoms.” In other studies, she said astaxanthin was shown to improve ROS [Reactive oxygen species] scavenging activity in the aqueous humor, thus supporting the delivery of oxygen to the lens.
Synergy with Omega-3s
While lutein and zeaxanthin are clearly a winning combination, research from the LUTEGA study published in 2013 in JAMA Ophthalmology suggested that omega-3s also offer a synergistic benefit to these ingredients. Trial results demonstrated that supplementation with a combination of lutein, zeaxanthin, docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) led to increased concentrations of lutein, zeaxanthin and fatty acids in plasma and a significant improvement in the optical density of the macular pigment.
The randomized, double-blind, placebo-controlled, parallel clinical trial evaluated 172 individuals with non-exudative (dry form) AMD over 12 months. Subjects were administered either a capsule containing 10 mg of lutein and 1 mg zeaxanthin (from FloraGLO lutein) and 100 mg DHA + 30 mg EPA, or twice these dosages (20/2/200/60).
The results found supplementation significantly improved the plasma antioxidant capacity, circulating macular xanthophyll levels, and the optical density of the macular pigment. Researchers said that these are important factors that could help minimize the risk of progression to wet AMD.
Neptune Technologies & Bioressources Inc., Laval, Quebec, Canada, is targeting the eye health category with the introduction of NKO Focus, which combines omega-3s with lutein and other essential vitamins. The condition-specific formulation is designed to support eye health and brain health by combining the benefits of krill oil with lutein esters, vitamin A and thiamine (vitamin B1).
When combined with NKO, a clinical trial showed lutein’s absorption improved by as much as eight times than a generic counterpart. NKO Focus also contains DHA and phospholipids known to support healthy brain function.
In a press release from the company, Jacqueline Khayat, Neptune’s sales director commented, “We took the ‘original’ NKO and gave it a boost, targeting brain and vision health. This is the first krill oil blend to offer such a powerful delivery mechanism to support brain and vision health. NKO is the perfect vehicle to increase bioavailability of other ingredients.”
Aimée Shunney, ND, a Nordic Naturals advisory board member, said that omega-3s are “crucial for optimal health throughout the lifespan—from womb to tomb.” However, she emphasized that long-chain omega-3 fats EPA and DHA are especially important during pregnancy and throughout infancy and childhood to ensure healthy nervous system development. “A growing number of studies in both human infants and animals support this idea, showing a strong correlation between the intake of omega-3 fats, especially DHA, and cognitive function, visual acuity and overall brain development,” she said.
A study published in the Journal of Nutrition in 2004, she noted, “measured the impact of DHA on visual development in 6-month-old infants and found that retinal and visual cortex maturation was greatly improved in infants receiving supplemental DHA versus infants who were deficient in DHA.”
To meet this important health need, Nordic Naturals, Watsonville, CA, introduced Omega Boost Junior, an omega-3 supplement for kids 2 years and older, positioned for eye health, brain health, immune function and nervous system function. A half-teaspoon serving (in liquid format) offers 285 mg of omega-3s in Paradise Punch flavor.
Various herbal supplements can also benefit eye function, in many cases due to their antioxidant potency.
Once such ingredient is Pycnogenol from Horphag, which the company’s Mr. Bornet said “provides potent antioxidant protection to the eyes, protects and strengthens retinal capillaries and has demonstrated the ability to stop further progression of early diabetic retinopathy. In fact, six clinical studies with more than 1,200 participants have demonstrated that Pycnogenol improves the vascular system of the eyes to preserve healthy eyesight.”
The most significant of these studies, he said, demonstrated Pycnogenol’s benefits for diabetic retinopathy. “In this study, 1,169 subjects with diabetes 1 and 2 participated and took Pycnogenol in dosages ranging from 20 mg to 160 mg, depending on severity of retinal bleedings, for six months. The outcome showed that on average, no further vision loss occurred, suggesting that Pycnogenol effectively stops the progression of retinopathy [Schonlau F. & Rohdewald P. International Ophthalmology, 2002].”
Don Stanek, director of sales for Linnea, Easton, PA, said younger supplement users in their 30s and 40s are looking for botanicals as they age in order to postpone or avoid the need for pharmaceutical intervention.
“Bilberry extract has been used for many, many years for eye health, specifically night blindness,” he said. “This goes back to the Royal Air Force during World War II. They ate bilberry jam and claimed their eyesight was better, at least at nighttime during battle. So anecdotally, bilberry has long been associated with eye support.”
The root of this association comes from bilberry’s antioxidant potency. “Bilberry is rich in anthocyanins; it’s a great product for macular degeneration because of its rich antioxidant content,” Mr. Stanek explained. “Antioxidant botanicals that are free radical scavenging are going to support overall health, in addition to eye health. If you’re generally healthy, your organs are going to be healthy, extending benefits to eye health, brain health and more.”
Mr. Stanek also pointed to the potential of the ingredient vinpocetine—a semi-herbal extract from the lesser periwinkle plant, which has indications for brain health. However, he said, “because it brings vitamins, and nutrients and oxygen to the capillaries and small blood vessels in the body, it also benefits the eyes.”
The antioxidant potential of vitamin E derived from annatto is also beneficial for eye health, according to research examining American River Nutrition’s DeltaGold branded annatto tocotrienol ingredient. Plant-based annatto tocotrienol was given in a topical formulation and was found to delay the onset and progression of cataracts in an experimental cataract rat model, according to findings published in 2014 in the journal Molecular Vision.
“The anti-cataract effect of tocotrienol could be attributed to reduced lenticular oxidative stress and attenuation of nitrosative stress,” concluded the researchers, led by pharmacologist Nafeeza Mohd Ismail of the Universiti Teknologi MARA, Malaysia.
“While previous reports note that tocotrienols are absorbed in ocular tissue, this is the first study examining their beneficial effect on cataract,” commented Barrie Tan, president of American River Nutrition Inc., Hadley, MA. “Tocotrienol at low levels works both as a chemical and biological antioxidant in a dose-dependent manner, and its preventive application in topical eye formulas may be especially useful for our rapidly expanding aging population.”
Focusing on Delivery
With vision a key health concern for people of all ages, developing products that meet the needs of consumers at all walks of life is essential.
“Consumers look for portable, easy delivery systems that fit into their lifestyles,” commented OmniActive’s Ms. Doyle. “Now that the demographic has expanded to a younger population, there needs to be a variety of options. Many formulas are now fortified with lutein. Gummies with lutein and zeaxanthin isomers could possibly be a stepping stone for formulators to create products that incorporate the macular carotenoids for young children who are unable to swallow tablets and capsules.”
Additionally, she said teens and on-the-go adults need options to meet their busy lifestyles. “They can reach for stick packs to add to their favorite beverages or even slip a gel packet into their pockets to get their lutein and zeaxanthin isomers easily anytime they want.”
Developing for seniors, the demographic most associated with use of lutein and zeaxanthin, is clearly an important consideration. Ms. Doyle noted, “Many seniors find it increasingly difficult to swallow pills as they get older. Gummies, stick packs and gel packets might be just what this senior population needs in order to continue macular carotenoid supplementation.”
Barbara Katz, president, HealthFocus International, St. Petersburg, FL, said there is significant potential for functional foods and beverages supporting eye health. “Forty-four percent of the [HealthFocus International 2013 U.S. Trend Study] respondents in the U.S. would be extremely interested in foods or beverages that could help maintain good eyesight. To put it in perspective, that’s a similar number to those interested in immunity and improving mental energy.”
However, Dr. Anshel suggested the obsession with low-fat products might pose formulation issues. “Fortification of foods might be a direction in the future but since they [carotenoids] are fat-soluble and need fats to be best absorbed, the public perception of low-fat needs to change.”
The most popular format, according to LycoRed’s Mr. Raz, is the traditional liquid-filled soft gel. “These soft-gels can contain a combination of lutein, lycopene, vitamins and minerals and other essential nutrients that were proven to reduce the risk for ARED.”
While standard pills and tablets are still most common for eye health supplements, Ms. Brown of AstaReal said that functional beverages are a growing category. “Although eye health beverages are not established so much yet, we see that as a trend.” In order to tap into this emerging opportunity, AstaReal developed a water-soluble form of astaxanthin, AstaReal HBA. “This new version of our natural astaxanthin is ideal for functional beverages and liquid supplements and will greatly support this growing trend.”
Dr. Anshel said the growing number of aging consumers will continue to expand the eye care market, however, he expects the industry’s focus to shift to better emphasize life-long protection of the eyes. “Since we know there is lutein in breast milk, young children are likely getting their proper dosage. However, if we don’t think about it again until the person is past the age of 50, then we have a huge age gap where many people go unprotected without these vital nutrients in their diets.”
While eye surgery such as Lasik is becoming more popular and commonplace, Horphag’s Mr. Bornet believes preventive care with dietary supplements will become a more preferable avenue. “As the natural eye health market continues to grow and advance, consumers are continuing to look for natural solutions to improve overall eye health vs. vision correcting surgeries or treatments.”
Continued research revolving around the importance of nutrition in safeguarding sight will continue to propel the eye health supplement category, according to OmniActive’s Ms. Doyle. “Scientific interest in lutein and zeaxanthin isomers has grown significantly over the last three decades, and we expect this trend to continue. More recent research has been focused in younger, healthy populations, where these macular carotenoids have been shown to improve visual acuity and visual performance, reduce glare sensitivity, enhance contrast sensitivity and improve vision in dim light. As research revealing the positive health benefits of lutein and zeaxanthin isomers continues to grow, so does consumer awareness of the need to incorporate these powerful eye health nutrients and potent antioxidants into daily supplementation.”
Lisa Olivo is the associate editor of Nutraceuticals World. She can be reached at email@example.com.
A clinical trial examining EyePromise EZ Tears found a 38% improvement in symptoms associated with dry eye.
The dietary supplement designed for individuals with irritated eyes, EyePromise EZ Tears, was clinically proven to provide relief after one week of oral supplementation. Published in Advances in Ophthalmology and Visual Systems on March 26, the formula from ZeaVision LLC, Chesterfield, MO, was examined to see how the proprietary combination of omega-3s, vitamin A, vitamin D3, vitamin E, evening primrose oil, turmeric extract and green tea extract, might benefit patients with dry eye symptoms.
Dry eye affects the ocular surface and tear film, which results in ocular discomfort, visual disturbances and tear instability. Without treatment these symptoms can often lead to corneal and conjunctival inflammation and damage. It is often the lack of sufficient lubrication on the corneal surface that causes dry eye symptoms. In many patients, symptoms include blurriness, stickiness and dryness; eyes often burn, sting or itch. Sufferers can also experience grittiness, as if a foreign particle is stuck in the eye.
“We know eye health and nutrition are connected,” said Dr. Sean Mulqueeny, OD, and principal investigator of the study. “That said, there are relatively few studies addressing the use of supplementation with omega-3 essential fatty acids and other nutrients for dry eye. The ONIT [Ocular Nutrition Impact on Tear Film] study yielded a remarkable result—welcome news for those desperate for dry eye symptom relief.”
He added, “One of the most surprising findings from this study was the rapid onset of action after initiation of supplementation. In clinical tests administered, patients began demonstrating improvement within 1 week, and improvements continued to increase over the 8-week study.”
Sixty-seven patients with clinically documented dry eye participated in the study. Patients were enrolled from the general practice patient population, meeting a minimum of four diagnostic inclusion criteria. Eighty-four percent of the patients were female; 20% were contact lens wearers; and two thirds of the females were post-menopausal.
Over the course of the study, participants ingested one daily dose (two softgels) of EyePromise EZ Tears. Patients were clinically assessed prior to supplementation, after 1 week, 4 weeks and 8 weeks. Tests evaluated the corneal surface, tear volume, quality, osmolarity and lid inflammation. Participants also completed the Ocular Surface Disease Index (OSDI) assessment prior to supplement initiation and at each subsequent visit to document change of comfort and vision. The 12-item OSDI questionnaire provides a rapid assessment of the symptoms of ocular irritation consistent with dry eye and impact on vision-related functioning. At the conclusion of 8 weeks, participants experienced a 38% improvement in their OSDI scores.