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TOZAL(R) Nutritional Supplement Improves Vision in Common Form of Macular Degeneration

- Multicenter study finds unique combination of micronutrients superior to current 'AREDS' standard of care; Results supported by new omega-3 study -

HOUSTON, Sept. 10 /PRNewswire/ -- A landmark study at five university-based research centers found that TOZAL(R), a patented combination of antioxidants and micronutrients, enabled patients with "dry" macular degeneration to improve their vision. Patients in the study's placebo arm, who received the "AREDS-type" nutritional formulation (the current standard of care), continued to lose their eyesight. Results of the TOZAL study are supported by a major new study, which shows that omega-3 acids cut the risk of developing "wet" macular degeneration.

"The TOZAL study demonstrates that treatment with this supplement can help patients with age-related vision loss," said lead investigator Francis E. Cangemi, M.D., a macular degeneration specialist affiliated with Vitreo-Retinal Associates of New Jersey.

At six months, 57 percent of those in the TOZAL treatment group improved an average of one-half eye-chart line of visual acuity, and 20 percent stayed the same. All patients in the placebo (AREDS-type nutritional supplement) arm lost visual acuity, with an average loss of 1.49 lines at the end of six months. The treatment group continued to show improvement over time, while most in the placebo group continued to lose visual acuity over time. The study was published in the February 2007 issue of BMC Ophthalmology, a peer-reviewed open-access medical journal.

Age-related macular degeneration is a progressive disorder associated with central vision loss and is the leading cause of visual impairment and blindness in people over age 60. More than 15 million Americans have macular degeneration, and an additional 50 million are at risk. Ninety percent of those with macular degeneration have the atrophic or "dry" form of the disease.

Although there is no cure for macular degeneration, the accepted standard of care since 2001 has been the use of nutritional supplements based on the federally funded Age-Related Eye Disease Study (AREDS). Further studies have suggested that the AREDS formulation is not optimal and clinical trials of a new formulation -- dubbed "AREDS II" -- are now underway. TOZAL's ingredients are similar to those in AREDS II, with some additional components. TOZAL is made from taurine, omega-3 fatty acids, zinc, antioxidants and lutein.

While the TOZAL study shows how a combination of nutritional components can arrest macular degeneration, a study published in an August 8 issue of The American Journal of Clinical Nutrition demonstrates that one critical ingredient in the TOZAL formulation -- omega-3 fatty acids -- can significantly reduce the risk of developing the disease. In a large population-based study in seven European countries, researchers found that seniors who had higher intakes of omega-3 docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) had far lower risks of developing wet macular degeneration. Those in the top 25 percent of DHA and EPA levels -- 300 milligrams a day and above -- reduced their risk by 70 percent. TOZAL is the only currently available eye-health formulation that contains these acids.

"While the AREDS II study will not be completed for five years, both of these studies demonstrate the value of trying this new nutritional approach right now to stave off five years of age-related vision loss," said Dr. Cangemi.

Dr. Cangemi enrolled 75 elderly patients in the TOZAL study who had at least one of their eyes diagnosed with dry macular degeneration. Study sites included New York Eye and Ear Infirmary, Ohio State University, University of California, Irvine and University of Texas, Austin. All patients were treated with the TOZAL formulation for six months.

Study participants saw the researchers during five visits over the six months, during which they repeatedly received a battery of eye tests. Participants were instructed to take TOZAL three times a day and to maintain a log, which was checked by researchers on each visit. The primary objective of the study was to measure change in visual acuity, while a secondary objective was to find improved macular function as measured by these tests.

"We saw significant improvements in visual acuity, but did not see demonstrated improvements in function," said Dr. Cangemi. "This is likely due to the short duration of the study."

The study's Institutional Review Board determined that all patients must receive the standard of care, so no true placebo arm was permitted. Instead, Dr. Cangemi used a widely accepted placebo protocol and constructed comparisons with placebo data from the "MIRA-1" study, which followed the same inclusion and exclusion criteria as TOZAL. All patients in the MIRA study -- including those in the placebo arm -- received AREDS supplements.

Patients in the TOZAL study were initially divided into two groups: those receiving TOZAL plus electrical microcurrent stimulation (MCS) and those receiving TOZAL and sham MCS. MCS was abandoned early in the study. Reported results are based on the arm of the study in which 37 patients received TOZAL and sham MCS.

TOZAL was developed by Edward L. Paul, O.D., Ph.D., an optometrist and nutritionist who is an authority on nutrition and vision loss. Dr. Paul has licensed the TOZAL formulation to AmeriSciences, a leading developer of science-based nutritional supplements that is based in Houston. He serves on the AmeriSciences Scientific Advisory Board.

Dr. Cangemi received funding for the study and manuscript preparation from Atlantic Medical, Inc., a company that holds patent rights to TOZAL.

SOURCE Atlantic Medical, Inc.
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