Promising Drug Slows Progression of Dry AMD by 45 Percent

Fenretinide, a drug being developed by Sirion Therapeutics, slowed the progression of advanced dry age-related macular degeneration (AMD) by 45 percent for people receiving a higher dose of the treatment in a Phase II clinical trial.

Currently, there are no FDA-approved treatments for dry AMD — a vision-robbing condition that affects more than 10 million Americans and millions more around the world.

Sirion has been granted a Fast Track designation for the treatment by the FDA. The designation provides a quicker review of a New Drug Application for fenretinide — six months instead of 10 months — enabling the treatment, if approved, to get to the market more quickly.

“The results for fenretinide are very encouraging,” says Stephen Rose, Ph.D., chief research officer, Foundation Fighting Blindness. “We are in great need for answers to one of the most prevalent vision-robbing conditions in developed countries, and fenretinide is showing real promise as a treatment for dry AMD and possibly other conditions.”

The Foundation funded earlier preclinical studies of fenretinide, which demonstrated the drug’s potential for slowing vision loss in people affected by dry AMD, Stargardt disease, Best disease, and other conditions characterized by the buildup of toxic waste products in the retina.

Individuals participating in the Phase II study received either one of two oral doses of fenretinide — 300 mg or 100 mg. While both doses slowed the growth of the harmful lesions associated with advanced dry AMD (also known as geographic atrophy), the higher dose was more effective. Lesion growth is associated with increased vision loss.

Sirion’s announcement is based on an 18-month interim analysis of Phase II study results for fenertinide. Additional data from the interim analysis will be presented in May 2009 at the annual meeting of the Association for Research in Vision and Ophthalmology.

Sirion is carrying the current Phase II study to its conclusion, and also planning a meeting with the FDA to design a Phase III study.