Lucentis Gains Approval to Treat Myopic Choroidal Neovascularization
Genentech announced that the Food and Drug Administration (FDA) has approved Lucentis (ranibizumab injection) for the treatment of patients with myopic choroidal neovascularization (mCNV). This approval marks Lucentis as the first anti-vascular endothelial growth factor (VEGF) approved to treat mCNV in the United States.
The FDA approval was based on data from the Phase 3, randomized, double-masked, active-controlled RADIANCE study, which compared the safety and efficacy of Lucentis 0.5mg vs. verteporfin photodynamic therapy (vPDT) in 276 patients with visual impairment due to mCNV. Study patients were randomized to two groups receiving Lucentis injections guided by pre-specified retreatment criteria and one group receiving vPDT.
The data showed Lucentis provided superior visual acuity gains in patients with mCNV vs. vPDT. Lucentis groups I and II had a mean change in best-corrected visual acuity of +12.1 and +12.5 letters from baseline, respectively, as compared to +1.4 letters for patients treated with vPDT. Efficacy between the Lucentis groups I and II was similar.
Lucentis, a VEGF inhibitor, is currently approved to treat patients with wet age-related macular degeneration (AMD), macular edema after retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR) in people with DME and now myopic choroidal neovascularization (mCNV). It is available as 6mg/mL and 10mg/mL strength solution for intravitreal injection in single-use vials.
For more information call (800) 821-8590 or visit Lucentis.com.