EU approves Lucentis (ranibizumab) for visual impairment

Novartis has announced that 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 (PM). With this approval, Lucentis is the first retinal treatment approved for these conditions, addressing an important unmet medical need.

The submission was supported by data from the Novartis sponsored MINERVA study, 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 CNV, regardless of the underlying etiology, with no new safety findings.

Comment: In September 2016 the EMA's Committee for Medicinal Products for Human Use recommended a change to the terms of the marketing authorisation for the medicinal product Lucentis. The CHMP adopted an extension to an existing indication as follows: In the EU, Lucentis should be indicated in adults for: 1 The treatment of neovascular (wet) age-related macular degeneration (AMD) 2 The treatment of visual impairment due to choroidal neovascularisation (CNV) 3 The treatment of visual impairment due to diabetic macular oedema (DME) 4 The treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO).