European Commission (EC) has granted an additional indication for Novartis’s Lucentis (ranibizumab) to treat patients with eye disease due to choroidal neovascularization (CNV) associated with causes other than neovascular age-related macular degeneration (nAMD), or secondary to pathologic myopia (PM).
Novartis noted that Lucentis is the first retinal treatment approved for this eye disease that deals with an important unmet medical need.
“This confirms Lucentis as standard of care in diseases of the retina,” said Paul Hudson, CEO Novartis Pharmaceuticals. “With this approval, Lucentis is the only treatment available for a wide range of choroidal neovascularization conditions. We are dedicated to bringing new innovations to the market, as we are aware that there is still high unmet medical need for patients with retinal diseases.”
The approval is applicable to all 28 European member states, as well as Iceland, Liechtenstein and Norway. It was based on the positive opinion from the Committee for Medicinal Products for Human Use (CHMP), adopted in October 2016. After this approval, Lucentis covers six indications in Europe. Submissions for this indication have been filed in 11 other countries, including Switzerland, Australia, Indonesia and Brazil.
About choroidal neovascularization eye disease
CNV 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. CNV 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 CNV).