FDAnews
www.fdanews.com/articles/61535-macusight-to-initiate-two-trials-of-sirolimus

MACUSIGHT TO INITIATE TWO TRIALS OF SIROLIMUS

August 8, 2006

MacuSight announced that the FDA has accepted the company's investigational new drug application for its proprietary formulation of sirolimus (rapamycin). The application covers the compound's development as a treatment for wet age-related macular degeneration and diabetic macular edema, a manifestation of diabetic retinopathy. The company intends to begin a Phase I trial of the drug in diabetic macular edema during the third quarter and a Phase I trial in age-related macular degeneration during the fourth quarter.

Sirolimus is a highly potent, broad-acting compound that has demonstrated the ability to combat disease through multiple mechanisms of action including immunosuppressive, anti-angiogenic, anti-migratory, anti-proliferative, anti-fibrotic and anti-permeability activity. MacuSight believes that sirolimus may serve as a potential therapeutic for a wide range of ocular diseases and conditions.