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Lucentis recommended for EU approval for sixth indication
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The Committee for Medicinal Products for Human Use has recommended the approval of Lucentis in the European Union for the treatment of patients with visual impairment due to choroidal neovascularization not caused by neovascular age-related macular degeneration or myopic choroidal neovascularization, Novartis announced.
The indication would be the sixth approved indication in Europe for use of Lucentis (ranibizumab).
A major cause of vision loss, CNV can occur with conditions including uveitis, central serous chorioretinopathy, angioid streaks, trauma and retinal or macular dystrophies, among others, a company press release said, and if approved, ranibizumab would be the first retinal treatment approved for these conditions.
The recommendation was supported by the MINERVA study, in which visual acuity gains achieved at 2 months were maintained at 1 year in patients with CNV, regardless of underlying etiology.
“Lucentis has already transformed the management of a number of ocular conditions, and we are hopeful that these additional patient groups affected by CNV will benefit from this treatment,” Vasant Narasimhan, global head of drug development and chief medical officer of Novartis, said in the release.
The treatment is already approved for the treatment of neovascular AMD and visual impairment caused by diabetic macular edema, branch retinal vein occlusion, central retinal vein occlusion and CNV secondary to pathologic myopia, the release said.