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FDA grants priority review for Lucentis for myopic CNV

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The FDA accepted a supplemental biologics license application and granted priority review for Lucentis for the treatment of myopic choroidal neovascularization, according to a Genentech press release.

The application is based on the 12-month, randomized, double-masked, multicenter phase 3 RADIANCE study, in which Lucentis (ranibizumab) provided “superior visual acuity gains” in patients with myopic CNV compared with verteporfin photodynamic therapy, the release said.

If approved, Lucentis would be the first FDA-approved anti-VEGF therapy to treat myopic CNV, which affects about 41,000 people in the United States, according to the release.

Lucentis is already approved by the FDA for the treatment of wet age-related macular degeneration, macular edema secondary to retinal vein occlusion, diabetic macular edema and diabetic retinopathy in patients with DME.