The European Commission has approved Novartis’ Lucentis® (ranibizumab) as a treatment for 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). Novartis said the antibody fragment VEGF-A inhibitor is the first retinal therapy approved for these indications. Regulatory clearance for this sixth indication for Lucentis covers all 28 European member states, along with Iceland, Liechtenstein, and Norway. Regulatory submissions have been filed in an additional 11 countries.
The latest European approval was based on data from the Minerva study, which showed that Lucentis therapy resulted in a significant gain of visual acuity by approximately 10 letters at two months. This improvement was maintained for up to the full 12 months of the one-year study. Novartis maintains that ranibizumab has proven to be effective for the treatment of CNV, regardless of the underlying etiology. “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 CNV conditions.”
Lucentis was developed by Genentech and Novartis. Genentech has the commercial rights to Lucentis in the U.S., with Novartis holding exclusive rights in the rest of the world. The drug is separately being investigated as combination therapy for retinal disorders. In October 2016 Ophthotech reported positive data from a Phase IIb combination therapy trial evaluating its lead anti-PDGF candidate, Fovista® (pegpleranib), in combination with Lucentis therapy in 449 patients with wet AMD. The trial data showed that in comparison with Lucentis therapy alone, the combination treatment with Fovista demonstrated a 62% additional benefit from baseline on the primary endpoint of mean visual acuity.
Ophthotech has now initiated a pivotal Phase III program to evaluate Fovista in combination with anti-VEGF therapies in patients with newly diagnosed wet AMD. In addition, Ophthotech and Novartis have inked a licensing and commercialization agreement granting the latter exclusive rights to commercialize Fovista in markets outside the U.S. Ophthotech retains sole rights to commercialize Fovista in the U.S., and will lead the global Phase III clinical program and the potential future U.S. registration of Fovista. Ophthotech and Novartis will collaborate on attaining regulatory approvals for Fovista outside the U.S.