FDA Approves Treatment for All Forms of Diabetic Retinopathy

The approval is based on a controlled study which compared Lucentis to panretinal laser treatment in 305 individuals
The approval is based on a controlled study which compared Lucentis to panretinal laser treatment in 305 individuals

Genentech announced that the Food and Drug Administration (FDA) has approved Lucentis (ranibizumab) injection 0.3mg for treatment of all forms of diabetic retinopathy. This approval marks Lucentis as the first approved drug to treat diabetic retinopathy in patients with or without diabetic macular edema (DME). 

Lucentis previously was approved for the treatment of diabetic retinopathy in patients with DME in February 2015. The FDA's Priority Review for the treatment of diabetic retinopathy without DME was based on data from the randomized, active-controlled Diabetic Retinopathy Clinical Research Network's (DRCR.net) Protocol S study (n=305) that compared Lucentis to panretinal laser treatment in diabetic retinopathy patients both with and without DME. 

The analysis indicated that patients with and without DME in the Lucentis treatment group had improvements in the severity of their retinopathy. Nearly 40% of patients in the Lucentis group without baseline DME had a 2-step or better improvement in their diabetic retinopathy, and 28.4% had a 3-step or better improvement at 2 years. Among patients with baseline DME, 58.5% had a 2-step or better improvement and 31.7% had a 3-step or better improvement at 2 years.  

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Lucentis, a vascular endothelial growth factor (VEGF) inhibitor binds to and inhibits VEGF-A. The binding of ranibizumab to VEGF-A prevents the interaction of VEGF-A with its receptors (VEGFR1 and VEGFR2) on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation. It is currently indicated to treat patients with wet age-related macular degeneration (AMD), macular edema after retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy and myopic choroidal neovascularization (mCNV). 

Lucentis is available as 6mg/mL and 10mg/mL strength solutions for intravitreal injection as single-use prefilled syringes and single-use vials. 

For more information call (800) 821-8590 or visit Lucentis.com.