Genentech announced that the Food and Drug Administration (FDA) has approved Lucentis (ranibizumab) injection for the treatment of diabetic retinopathy in patients with diabetic macular edema (DME). Lucentis is the first ophthalmic drug approved for diabetic retinopathy in patients with DME.

Lucentis is a vascular endothelial growth factor (VEGF) inhibitor already approved for neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), and DME. It works by binding to and inhibiting VEGF-A, a protein involved in angiogenesis and the hyperpermeability of the vessels.

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The FDA approval was based on data from two Phase 3 identically-designed, parallel, double-masked, sham treatment-controlled clinical trials: RISE and RIDE. A total of 759 patients with diabetic retinopathy and DME were randomized to receive Lucentis 0.3mg monthly, Lucentis 0.5mg monthly, or sham injection. The primary outcome in RISE and RIDE was visual acuity gain at 24 months for DME patients. Results showed that Month 24, a greater proportion of patients experienced a 3-step or better improvement of their disease vs. the sham group, as determined by color fundus photography.

Lucentis is available as 0.05mL single-use vials to provide 6mg/mL and 10mg/mL strengths solutions for intravitreal injection.

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