Lucentis to treat patients for visual impairment due to choroidal neovascularization associated with causes other than neovascular age-related macular degeneration or secondary to pathologic myopia, EC approved
The European Commission ( EC ) has granted an additional indication for Lucentis ( Ranibizumab ) to treat patients with visual impairment due to choroidal neovascularization ( CNV ) associated with causes other than neovascular age-related macular degeneration ( nAMD ), or secondary to pathologic myopia.
With this approval, Lucentis is the first retinal treatment approved for these conditions.
The approval is based on the positive opinion from the Committee for Medicinal Products for Human Use ( CHMP ), adopted in October 2016.
Following this approval, Lucentis covers six indications in Europe.
Choroidal neovascularization is an ocular condition caused by the growth of abnormal blood vessels below the retina, which cause disruption to vision. The condition can occur rapidly, and is a major cause of vision loss, causing symptoms including visual distortion, color disturbances, partial loss of vison or a blindspot within the visual field.
Choroidal neovascularization is most commonly associated with neovascular ( wet ) age-related macular degeneration and pathologic myopia, but it can also occur with many other conditions including uveitis, central serous chorioretinopathy, angioid streaks, trauma, retinal or macular dystrophies, and with no apparent cause ( idiopathic choroidal neovascularization ).
The submission was supported by data from MINERVA trial, which showed that Lucentis treatment resulted in a significant gain of visual acuity by approximately 10 letters at two months; this gain was maintained to month 12 of the one-year study.
Ranibizumab has therefore proven to be effective for the treatment of choroidal neovascularization, regardless of the underlying etiology, with no new safety findings.
Lucentis is a humanized therapeutic antibody fragment designed to block all biologically active forms of vascular endothelial cell growth factor-A ( VEGF-A ). Increased levels of VEGF-A are seen in nAMD and other ocular diseases such as DME and retinal vein occlusion ( RVO ).
Lucentis was specifically designed for the eye, minimizing systemic exposure.
Lucentis is licensed for the treatment of neovascular age-related macular degeneration, and for the treatment of visual impairment due to choroidal neovascularization, diabetic macular edema, branch retinal vein occlusion and central retinal vein occlusion. ( Xagena )
Source: Novartis, 2016