The FDA today expanded the indication of Roche's ranibizumab (Lucentis), approving the drug for the treatment of diabetic retinopathy in patients with diabetic macular edema.
The FDA today expanded the indication of Roche’s ranibizumab (Lucentis), approving the drug for the treatment of diabetic retinopathy (DR) in patients with diabetic macular edema (DME).
Lucentis, a vascular endothelial growth factor (VEGF), was previously approved to treat DME and macular edema secondary to retinal vein occlusions, as well as wet (neovascular) age-related macular degeneration. A supplemental New Drug Application to include the treatment of DR in the drug’s approved uses was granted priority review by the FDA in October 2014.
The FDA based its nod on positive results from 2 clinical studies evaluating the safety and efficacy of Lucentis in 759 patients with DR. Compared with patients who did not receive treatment, Lucentis-treated participants reported significant improvement in their DR’s severity after 2 years.
“Diabetes is a serious public health crisis, affecting more patients every year,” said Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, in a press release. “Today’s approval gives patients with diabetic retinopathy and diabetic macular edema the first significant therapy to treat this vision-impairing complication.”
The most common adverse events reported by trial participants treated with Lucentis include bleeding of the conjunctiva, eye pain, floaters, and increased intraocular pressure inside the eye. Several Lucentis-treated patients experienced more serious side effects such as endophthalmitis and retinal detachments.
DR, a leading cause of blindness in adults in the United States, is the most common eye disease associated with diabetes.