The European Commission has approved the sixth indication for Novartis’ Lucentis, making it the only treatment available for a range of choroidal neovascularization (CNV) conditions.
Lucentis (ranibizumab) has now been cleared to treat patients for visual impairment due to CNV associated with causes other than neovascular age-related macular degeneration (nAMD) or secondary to pathologic myopia (PM).
Regulatory clearance for the sixth indication covers all 28 European member states, along with Iceland, Liechtenstein, and Norway. The company filed regulatory submissions in an additional 11 countries.
The latest approval was based on data from the Minerva study, which demonstrated that treatment with Lucentis therapy resulted in a significant gain of visual acuity by about 10 letters at two months.
The improvement was maintained for up to the full 12 months of the one-year study.
Genentech and Novartis developed Lucentis, which is a humanized therapeutic antibody fragment designed to block all biologically active forms of vascular endothelial cell growth factor-A.
Genentech holds the commercial rights to Lucentis in the US, with Novartis owns exclusive rights in the remaining parts of the world.
Lucentis is licensed to treat nAMD and visual impairment due to CNV, DME, BRVO and CRVO.
Novartis said the safety profile of Lucentis has been well established in a clinical development program that enrolled over 76,000 patients across indications and has 3.7 million patient-treatment years of exposure since its launch in the US in 2006.
The drug is separately being studied as combination therapy for retinal disorders.
Image: View of the Fabrikstrasse, Novartis headquarters in Switzerland. Photo: courtesy of Novartis AG.