The FDA has expanded the approved use for Roches' Lucentis (ranibizumab injection) 0.3 mg to treat diabetic retinopathy (DR) in patients with diabetic macular edema (DME). Lucentis is administered by a physician as an injection into the eye once a month. It is intended to be used along with appropriate interventions to control blood sugar, blood pressure and cholesterol.The FDA granted Lucentis for DR with DME breakthrough therapy designation
The drug’s safety and efficacy to treat DR with DME were established in two clinical studies involving 759 participants who were treated and followed for three years. In the two studies, participants being treated with Lucentis showed significant improvement in the severity of their DR at two years compared to patients who did not receive an injection.
The FDA previously had approved Lucentis to treat DME and macular edema secondary to retinal vein occlusions, both of which cause fluid to leak into the macula resulting in blurred vision. Lucentis also is approved to treat wet (neovascular) age-related macular degeneration, a condition in which abnormal blood vessels grow and leak fluid into the macula.