Clinical Study Gives New Hope to Patients with Age-Related Macular Degeneration.

Health/Medical Writers

ROME--(BUSINESS WIRE)--June 9, 2003

There is new hope for patients in the early stages of Age-Related Macular Degeneration (AMD), the leading cause of blindness in older adults. A double-blind, placebo-controlled study has found that patients with early AMD showed a statistically significant improvement in visual function when treated with Phototrop, a compound that combines acetyl-L-carnitine, highly concentrated omega-3, and coenzyme Q10.

The findings were reported for the first time in the United States at the Association for Research in Vision and Ophthalmology (ARVO) annual meeting in Fort Lauderdale.

Phototrop was developed by sigma-tau HealthScience, a wholly-owned subsidiary of the Italian pharmaceutical company sigma-tau S.p.A. It currently is only available in Italy, where it is being marketed to ophthalmologists, but sigma-tau HealthScience is evaluating several options for U.S. distribution.

"The combination of a good omega-3 product with the acetyl-L-carnitine proved to be effective in the controlled clinical research," said Janos Feher, M.D., Department of Ophthalmology, University of Rome La Sapienza, the study's lead researcher. "Based on the results of our research, we believe patients with early AMD will benefit from taking Phototrop."

Currently, there are few treatments for older adults suffering from degeneration of the macula - the center of the retina. Although the cause of AMD is still unknown, 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 retinal functions.

"A previous pilot study had shown that patients with early AMD showed an improvement when given this combination of acetyl-L-carnitine, omega-3 and coenzyme Q10," Dr. Feher said. "We used a double-blind, placebo-controlled study - an approach that is still quite rare in the field of dietary supplements - to confirm those findings."

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. sigma-tau HealthScience was established in 1998 to pursue the development of these compounds in the nutritional supplement area using pharmaceutical-quality standards. For more information about the company, please visit www.st-hs.com.