Full US approval goes to diabetic retinopathy drug Lucentis
Lucentis® has become the only drug available in the US market which can be used to manage the diabetic eye condition with or without diabetic macular edema (DME), it has been announced.
The monthly ranibizumab injection has now been approved to treat all forms of diabetic retinopathy after the US Food and Drug Administration (FDA) gave it the stamp of approval.
The drug was developed by Genentech which is a part of Roche. Sandra Horning, who is the chief medical officer and head global product development at Genentech, said: “Diabetic retinopathy is the leading cause of vision loss among working-aged adults in the US between the ages of 20 and 74. We are very pleased that Lucentis is now FDA-approved to treat retinopathy in people with and without DME.”
Medicines are granted FDA approval if study results show the drug could be a potential improvement in the safety and effectiveness of the treatment of a serious disease.
In the most recent trial that tested Lucentis®, the drug was compared to pan retinal laser therapy in more than 300 people with diabetic retinopathy.
Ms Horning added: “In multiple clinical studies, Lucentis demonstrated a significant improvement of patients’ diabetic retinopathy, and it is the first and only anti-VEGF therapy approved to treat all forms of diabetic retinopathy.”
The treatment is also approved for wet age-related macular degeneration, macular edema after retinal vein occlusion, myopic choroidal neovascularization and diabetic macular edema.