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news.Genentech, a member of the Roche Group, has received approval from the FDA after a six-month Priority Review of Lucentis (ranibizumab injection), indicated for the treatment of macular edema following retinal vein occlusion (RVO).
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Lucentis is a vascular endothelial growth factor (VEGF) inhibitor which was first approved by the FDA for the treatment of neovascular (wet) age-related macular degeneration (AMD) in 2006.
Lucentis is known to bind to and inhibit VEGF-A, a protein that plays a critical role in the formation of new blood vessels (angiogenesis) and the hyperpermeability (leakiness) of the vessels.
Genentech said that the safety and efficacy profile of Lucentis was analysed in a total of 397 patients with macular edema following branch-RVO through the Bravo study, while the safety and efficacy profile of Lucentis in a total of 392 patients with macular edema following central-RVO was analysed through the Cruise study.
Hal Barron, executive vice president of global development and chief medical officer at Genentech, said: “This approval provides an important new medicine for people experiencing the unexpected vision loss associated with macular edema following RVO.
“In the Lucentis RVO clinical trials more people treated with monthly Lucentis showed vision improvement during the six-month study with an effect seen as early as seven days.”