Basis for VisiVite's Eye Vitamin Formulas

Vitamin Science Inc began in 2001 with the expressed intent of providing nutritional supplementation formulas for ophthalmic conditions. Vitamin Science now makes various formulas for both macular degeneration and Dry Eye Syndrome.

Macular Degeneration Overview and AREDS

Macular degeneration is a leading cause of irreversible legal blindness in the world. It causes decline and loss of central vision, which is the area responsible for being able to see details, such as read a book and recognize faces. It is extremely common in elderly caucasion patients. Clinical findings of dry macular degeneration include drusen, atrophy, and irregular pigmentation. Histopathologically, there are disturbances below the retina in Bruch’s membrane and sometimes the vascular choroid layer that result in atrophy and dysfunction of the overlying retina.

Until recently, treatment options for macular degeneration were limited. Dry macular degeneration was unresponsive to laser and oral supplements such as Ocuvite and ICaps. Wet macular degeneration was treated with Argon laser, ablating the neovascular but at the result of a vision losing scar. Because of the severe vision losses associated with late stages of dry macular degeneration and progression from dry to wet macular degeneration, a treatment that could prevent this progression was needed.

However, the National Eye Institute’s Age Related Eye Disease study showed for the first time ever that nutritional supplementation, with the right ingredients and high enough quantities, successfully reduced the progression of dry (atrophic) wet macular degeneration. The Age-Related Eye Disease Study involved 4,757 participants, 55-80 years of age, in 11 clinical centers nationwide. Participants in the study were given one of four treatments: 1) zinc alone; 2) antioxidants alone; 3) a combination of antioxidants and zinc; or 4) a placebo, a harmless substance that has no medical effect. The benefits of the nutrients were seen only in people who began the study at high risk for developing advanced AMD -- those with intermediate AMD, and those with advanced AMD in one eye only. In this group, those taking "antioxidants plus zinc" had the lowest risk of developing advanced stages of AMD and its accompanying visual loss. Those in the "zinc alone" or "antioxidant alone" groups also reduced their risk of developing advanced AMD, but at more moderate rates compared to the "antioxidants plus zinc" group. Those in the placebo group had the highest risk of developing advanced AMD.

Benefits were seen in patients with both moderate and severe forms of AMD. Scientists found that people at high risk of developing advanced stages of AMD, a leading cause of vision loss, lowered their risk by about 25 percent when treated with a high-dose combination of vitamin C, vitamin E, beta-carotene, and zinc. In the same high risk group -- which includes people with intermediate AMD, or advanced AMD in one eye but not the other eye -- the nutrients reduced the risk of vision loss caused by advanced AMD by about 19 percent.

While these numbers are not as high as we might prefer, AREDS was the first study of its kind showing clear and significant benefit to nutritional supplementation.

The AREDS participants reported few side effects from the treatments. About 7.5 percent of participants assigned to the zinc treatments -- compared with five percent who did not have zinc in their assigned treatment -- had urinary tract problems that required hospitalization. Participants in the two groups that took zinc also reported anemia at a slightly higher rate; however, testing of all patients for this disorder showed no difference among treatment groups. Yellowing of the skin, a well-known side effect of large doses of beta-carotene, was reported slightly more often by participants taking antioxidants.

The failings of AREDS

1. AREDS utilized the less expensive synthetic, rather than natural vitamin E. Synthetic vitamin E is formed by chemically combining two molecules. The resultant Vitamin E contains both right-handed (D form) and left-handed (L form) molecules. Hence, the Vitamin E listed on many AREDS supplements list dl-alpha tocopherol. Unfortunately, only the D, or right handed form of the Vitamin E molecule is biologically active. Therefore, half of the vitamin E is these mixtures is the “L” type, which can be considered a biological contaminant with no biologic activity. This is particularly important in view of a large retrospective meta-analysis study from Johns Hopkins which showed higher incidence of cardiac events when patients too more than 400 IU of Vitamin E daily. It is our contention that the risks of Vitamin E are higher when taking synthetic rather than Natural (vegetable) forms of Vitamin E. VisiVite uses only Natural Vitamin E.
   
   

2. There are three common chemically related compounds, known as carotenoids: the beta-carotene form of Vitamin A, Lutein and Zeaxanthin. AREDS studied beta carotene, despite the fact that the carotenoids that are found in the highest concentration in normal, healthy maculas are Lutein and Zeaxanthin. These chemicals serve two important functions. Their natural pigmentation blocks the harmful effects of ultraviolet light. Secondly, they act as antioxidants, scavenging for free radical oxygen molecules and reducing degenerative and cancerous disease. Lutein and Zeaxanthin are found in Marigold flowers. Both molecules have received the FDA’s coveted GRAS (generally regarded as safe) designation. These molecules are now thought to be so important that the National Eye Institute has announced an “AREDS 2 Study” in which either one or both of these important compounds will be part of the study formula. The FloraGLO brand Lutein and Optisharp brand Zeaxanthin in VisiVite products are the same right handed molecular form that is found in nature. There is evidence from the National Eye Institute supporting Lutein and Zeaxanthin. In 1994, a National Eye Institute (NEI)-supported study indicated that consumption of foods rich in carotenoids -- particularly green, leafy vegetables such as collard greens, kale, and spinach -- was associated with a reduced risk of developing AMD. In 2001, data from the Third National Health and Nutrition Examination Survey reported that higher intakes of lutein and zeaxanthin among people ages 40-59 may be associated with a reduced risk of advanced AMD. Importantly, AREDS did not include either Lutein or Zeaxanthin because at the time the study was instituted, these compounds were not commercially available.
   
   

3. Beta-carotene is a form of Vitamin A. Though it may cause some yellowing of the skin, it is thought to be otherwise benign in most people. Patients with a habitual smoking history are the exception. There are now three large, population based studies demonstrating a higher risk of lung cancer in habitual smokers. And since beta-carotene is one of the five ingredients in the AREDS Formula, this means that current smokers and recent habitual smokers are advised not to take the AREDS Formula, removing the benefits of taking this for a large segment of the population. Vitamin Science therefore has specific formula designed with the needs of smokers in mind. By adding carotenoids other than beta-carotene, namely Lutein and Zeaxanthin, to their macular degeneration formulas, this ensures benefit to the patient without the potential adverse health risks that the AREDS Formula would otherwise entail.
   
   

4. Of the potential side effects of the AREDS formula, urinary tract problems carry the greatest patient worry. Although Vitamin Science provides a formula that is strictly based upon AREDS with 80 mg of Zinc Oxide, all VisiVite i-Defense Formulas reduce Zinc to 40 mg while adding Lutein, Zeaxanthin and other beneficial anti-oxidants. Because AREDS showed benefit to anti-oxidants alone and Zinc alone, the reduced Zinc and additional antioxidants results in a vitamin formula that is equal, and probably superior to AREDS, while minimizing a side effect that would otherwise cause a patient to discontinue his or her therapy with vitamin supplementation.

Other benefits to VisiVite

All VisiVite Formulas are provided as gelatin capsules. This gives the ingredients high bioavailability and requires only two total capsules daily in divided doses. Capsule contents can be readily emptied into food or drink for those patients who have difficulty swallowing.

The selection of which vitamin supplement to choose can be confusing for patients. Not uncommonly, patients falsely believe that they are taking an AREDS formula, only for the doctor to discover that the patient is taking Ocuvite, a formula that contains a small fraction of the nutrients in Ocuvite Preservision. In fact, patients are often at a loss to tell their doctors which of the four Ocuvite formulas they are taking. In contrast, VisiVite Macular Degeneration Formulas are clearly labeled and the VisiVite i-Defense formulas are color-coded, with unique packaging and capsule color: This makes it easy for the patient to remember that he or she takes the “Yellow” formula. And it makes it easy for physicians to remember that smokers must take either the “Red” or “Green” formulas.

All VisiVite formulas are manufactured in a laboratory that has received the National Nutritional Foods Association’s certification for Good Manufacturing Practice. As of October 2005, there are only 52 GMP certified laboratories worldwide.

VisiVite’s premium formulas include molecules with strong antioxidant activity and high patient recognition. These include:

• Bilberry- is a powerful member of a class of compounds known as Anthocyanidin Bioflavonoids. These bioflavonoids are particularly effective in strengthening capillaries and in improving night vision.
  
  
• Grape Seed Extract - Grape seed extract is a natural plant substance that has a concentrated source of oligomeric proanthocyanidins (OPC). These anti-oxidants help protect cells from free radical damage and also promote healthy circulation. Grape Seed Extract is rich in polyphenols, a compound that's high in antioxidants. Studies have shown OPC to be more powerful antioxidants than vitamin C, E, and beta-carotene.
  
  
• L-Glutathione – This is a powerful anti-oxidant with an extensive body of scientific literature. Glutathione (GSH) is a tripeptide, found in human cell tissue, formed from the amino acids cysteine, glycine, and glutamic acid. The "glutathione antioxidant system" is foremost among these internal protective systems because glutathione participates directly in the destruction of reactive oxygen compounds. Glutathione destroys free radicals, is involved in the detoxification of foreign compounds such as carcinogens, etc., and supports the normal active functioning of the immune system. It is our body's Master Antioxidant.Glutathione plays a key role in the body’s defense against pollutants and ultraviolet radiation. The highest concentration of glutathione is found in the liver which is the principal organ involved in the detoxification and elimination of toxic materials.
  
  
• Selenium - Selenium has a variety of functions. The main one is its role as an antioxidant in the enzyme selenium-glutathione-peroxidase. This enzyme neutralizes hydrogen peroxide, which is produced by some cell processes and would otherwise damage cell membranes.