Priority Review Granted to Lucentis for Vision-Threatening Condition

The Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA), and granted Priority Review, for Lucentis (ranibizumab injection; Genentech), to expand its indication for the treatment of myopic choroidal neovascularization (mCNV).

Lucentis is currently approved to treat patients with wet age-related macular degeneration (AMD), macular edema after retinal vein occlusion (RVO), diabetic macular edema (DME) and diabetic retinopathy (DR) in people with DME.

The new sBLA is based on results from the Phase 3 Radiance study, which showed superiority in visual acuity gains compared to verteporfin photodynamic therapy in people with mCNV. A total of 277 patients with mCNV took part in the Radiance Phase 3 trial; a 12-month, randomized, double-masked, multicenter, active-controlled study comparing the efficacy and safety of Lucentis (0.5mg) versus verteporfin photodynamic therapy (vPDT). Results showed that after 3 months of treatment the two Lucentis groups gained 10.5 and 10.6 letters in visual acuity vs. the vPDT group which gained 2.2 letters.

If approved, Lucentis would be the first FDA-approved anti-vascular endothelial growth factor (VEGF) therapy to treat mCNV.

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