FDA Approves Lucentis for Diabetic Retinopathy With Diabetic Macular Edema

The FDA has expanded the approved use for ranibizumab injection (Lucentis, Genentech) to include treatment for diabetic retinopathy in patients with diabetic macular edema, according to a press release.

Lucentis previously received FDA approval for treatment of diabetic macular edema and macular edema secondary to retinal vein occlusions. The drug is also approved to treat wet (neovascular) age-related macular degeneration.

The agency granted Lucentis for diabetic retinopathy with diabetic macular edema breakthrough therapy designation and, in October 2014, reviewed the new use for Lucentis under the FDA’s priority review program.

“Diabetes is a serious public health crisis, affecting more patients every year,” Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “[This] approval gives patients with diabetic retinopathy and diabetic macular edema the first significant therapy to treat this vision-impairing complication.”

Ranibizumab 0.3 mg is administered via injection into the eye once monthly and is intended to be used along with other interventions to control glucose levels, blood pressure (BP) and cholesterol.