DEC 16, 2014
Comprehensive Ophthalmology, Retina/Vitreous
The U.S. FDA has granted breakthrough therapy designation for Lucentis for the treatment of diabetic retinopathy, according to Genentech.
The FDA previously granted the drug priority review status. The new designation will allow the company to expedite the development and review of Lucentis for diabetic retinopathy. If approved, this will be the fourth indication for Lucentis since 2006.
The FDA grants breakthrough status if a drug is intended to treat a serious or life-threatening disease or if preliminary clinical research suggests it will provide a significant improvement over existing therapies.