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Clinical Study: Patients with Early Age-Related Macular Degeneration Benefit from Phototrop(R)

NEW ORLEANS (October 25, 2004) – Phototrop®, a patented dietary supplement that combines acetyl L-carnitine, highly concentrated omega-3 and coenzyme Q 10, may support and maintain visual function in an elderly patient population at increased risk of developing vision loss. These findings of a double-blind, placebo-controlled study, will be presented today at the 2004 American Academy of Ophthalmology and European Society of Ophthalmology Joint Meeting in New Orleans.

Researchers studied the effect of Phototrop® on 106 patients in the early stages of AMD. The researchers found that the patients experienced a statistically significant decrease in drusen, yellow deposits that accumulate under the retina. As the size and number of drusen increase, central vision can be impaired making it difficult to read or drive.

Phototrop® was developed by sigma-tau HealthScience, a wholly-owned subsidiary of the Italian pharmaceutical company sigma-tau S.p.A. Phototrop® will be available in the United States by the end of the year through the web site:

“Our study found a statistically significant decrease in the drusen-covered areas of the eyes of those who were administered Phototropâ for a one-year-period, while they increased in those who were taking the placebo,” said the study’s lead researcher, Professor Janos Feher, Department of Ophthalmology, University of Rome La Sapienza. “Phototrop® is the only formulation on the market proven to support visual function by facilitating the re-absorption of drusen.”

There currently are few treatments for older adults suffering from the early stages of degeneration of the macula --- the center of the retina. Advanced AMD is the leading cause of blindness in people 65 and older.

Although little is known about what triggers AMD, previous research has shown that the decline of mitochondrial function and the oxidation of the retina’s cellular membranes play a central role in the disease’s onset and progression. The recent study was aimed at testing the effectiveness of certain compounds that restore mitochondrial and peroxisomal efficiency and support the maintenance and function of photoreceptor cells, or the rods and cones that convert light energy into vision.

Study Overview

The double-blind, placebo-controlled, single-center study carried out in Hungary was titled “Improvement of Fundus Alterations in Early AMD Treated With a Combination of Acetyl-L-Carnitine, Highly Concentrated N-3 Fatty Acids, and Coenzyme Q10” The 106 patients enrolled in the study were aged 55 to 70 and had been diagnosed with early AMD. There was no significant difference between the treatment groups at screening.

The primary objective of the study was to determine how Phototropâ influenced visual functions of patients aged 55 to 70 years with early AMD after 12 months of treatment compared with placebo-treated patients. The study was also aimed at evaluating changes in fundus alterations or the drusen-covered areas. Finally, the safety of the product was considered.

The findings justify an assumption that an appropriate combination of mitotropic compounds (those that influence mitochondrial metabolism) improves visual functions in early AMD and diminish the risk of vision loss associated with more advanced stages of the disease.

About Phototrop®

In currently incurable neurodegenerative diseases such as macular degeneration, improvement, stabilization or a slower progression of the disease over time are considered a positive response to treatment. These types of responses were observed in patients treated with Phototropâ in clinical trials for early AMD.

Phototrop® contains a combination of acetyl-L-carnitine, highly concentrated omega-3 fatty acids, and coenzyme Q10. Acetyl L-carnitine improves mitochondrial functions, particularly lipid metabolism. Omega-3 fatty acids play an important role as structural membrane lipids, particularly in nerve tissue and the retina. Coenzyme Q10, is a powerful antioxidant and a component of the mitochondrial electron transport chain.

About The Metabolic Approach

sigma-tau HealthScience is addressing the problems associated with a longer life by pioneering The Metabolic Approach to health and well-being. “This approach is unique because it focuses on the role that nutritional supplements can play in reversing the cellular and molecular problems that lead to disease and aging even before symptoms are evident,” said Dr. Massimo Picari, M.D., director of strategic marketing and communications at sigma-tau HealthScience. The Metabolic Approach is based on the assumption that a proper combination of endogenous and other natural compounds (e.g. carnitines, Coenzyme Q10, omega-3, etc.) can provide metabolic support that removes or minimizes the cause of cell damage long before symptoms appear and well before they ultimately evolve into conditions that are detrimental to good health.

About sigma-tau

Founded in 1957, sigma-tau S.p.A. has focused the largest part of its research on the development of metabolic compounds, i.e. molecules that occur within the human body. The company has either sponsored or been involved in 70 percent of all the research ever done on L-carnitine, and holds more than 150 related patents. sigma-tau’s L-carnitine is approved by the U.S. Food and Drug Administration (FDA), as well as 31 other health ministries worldwide.
sigma-tau HealthScience was established in 1998 to pursue the development of these compounds in the nutritional supplement area. All of the company’s products, from raw materials to finished formulations, meet pharmaceutical grade quality standards and are produced according to GMP guidelines. The sigma-tau HealthScience company philosophy is that only pharmaceutical quality products supported by the strongest scientific research and testing should be made available to healthcare professionals and consumers. Product quality backed up by strong science, research and development and thorough testing are the foundation of the sigma-tau HealthScience product system. For more information about the company, please visit



Purposes: The aim of this randomized, double-masked, placebo controlled clinical trial was to determine the efficacy of a combination of acetyl-L-carnitine, highly concentrated n-3 fatty acids, and coenzyme Q10 (Phototrop®) on the visual functions and fundus alterations in early age-related macular degeneration (AMD).

Methods: One hundred six patients with a clinical diagnosis of early AMD were randomized to the treated or control group. The primary efficacy variable was the change in the visual field mean defect (VFMD) from baseline to 12 months of treatment, with secondary efficacy parameters of visual acuity (Snellen chart and ETDRS chart), and foveal sensitivity as measured by perimetry. Fundus photographs taken at the screening and after 12 months were evaluated according to the criteria of the International Classification and Grading System for AMD.

Results: The mean change in all four parameters of visual functions showed significant improvement in the treated group by the end of the study period. In addition, in the treated group only 1 out of 48 cases (2%), while in the placebo group 9 out of 53 (17%) showed clinically significant (>2.0dB) worsening in VFMD (p= 0.006, odds ratio:10.93). Decrease in the drusen covered area of treated eyes was also statistically significant as compared to placebo when the most affected eyes (p=0.045) or the less affected eyes ( p=0,017) were considered.

Conclusions: These findings strongly suggested that an appropriate combination of compounds which affect mitochondrial lipid metabolism, may improve and subsequently stabilize visual functions, and may also prevent visual impairment, as well as it may also improve fundus alterations in patients affected by early AMD. No safety concerns on Phototropâ were raised in this study,

Marc Tewey
sigma-tau Pharmaceuticals Inc.

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