The product, called Phototrop, and manufactured by Italian firm sigma-tau HealthScience, is currently available in Italy and Hungary, with launches planned in the Netherlands and Belgium at the end of this month.
The double-blind, placebo-controlled study on 106 patients in the early stages of AMD demonstrated a statistically significant decrease in drusen, yellow deposits that accumulate under the retina, after one year of treatment. As the size and number of drusen increase, central vision can be impaired making it difficult to read or drive.
The drusen-covered areas of the eyes increased in those who were taking the placebo, said the study's lead researcher, Professor Janos Feher from the department of ophthalmology at the University of Rome La Sapienza. Sigma-tau claims that Phototrop is the only formulation on the market proven to support visual function by facilitating the re-absorption of drusen.
"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," concluded the researchers.
The findings were presented last week at the American Academy of Ophthalmology and European Society of Ophthalmology joint meeting in New Orleans. The single-centre study carried out in Hungary was previously discussed at the Arvo meeting in the US last year and has just been accepted for publication in the journal of the European society for ophthalmology, Opthalmologica.
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 company suggests that acetyl L-carnitine improves mitochondrial functions, particularly lipid metabolism, while 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.