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www.fdanews.com/articles/178860-priority-review-approved-for-genentechs-lucentis-in-myopic-neovascularization

Priority Review Approved for Genentech’s Lucentis in Myopic Neovascularization

October 13, 2016

FDA granted Priority Review for Lucentis (ranibizumab injection) for the treatment of myopic choroidal neovascularization, a complication of severe near-sightedness that can lead to blindness.

The supplemental BLA is based on results from a Phase III study that demonstrated treatment with Lucentis provided superior visual acuity gains in people with mCNV compared to verteporfin photodynamic therapy, the only treatment currently approved by the FDA for mCNV, according to Genentech, the biologic’s sponsor.

Lucentis is approved for wet age-related macular degeneration, macular edema after retinal vein occlusion, and diabetic macular edema and related diabetic retinopathy.

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