Lupin announced the completion of a global Phase 3 clinical study of LUBT010, its biosimilar candidate to Lucentis. The study has achieved its primary endpoint of therapeutic equivalence in visual acuity improvement for wet AMD patients, showcasing comparable safety and immunogenicity between LUBT010 and Lucentis.
Lupin has been marketing its ranibizumab biosimilar in India under the brand name RaniEyes since 2022. Ranibizumab is a recombinant humanised IgG1 kappa isotype monoclonal antibody fragment used in the treatment of Neovascular Age-related Macular Degeneration (also called wet AMD), Macular Edema Following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), Diabetic Retinopathy (DR) and Myopic Choroidal Neovascularization (mCNV).
The l Phase 3 study was designed as a global clinical trial, in line with recommendations from EMA and the US FDA, to evaluate the efficacy, safety, and immunogenicity of LUBT010 versus Lucentis in patients with Neovascular Age-related Macular Degeneration. A total of 600 patients from India, the US, the EU and Russia were randomised in the study and received either LUBT010 or Lucentis 0.5 mg, administered as an intravitreal injection once a month for 12 months. Patients were followed for efficacy, safety and immunogenicity assessment. The data from this Phase 3 study will be part of Lupin’s application for marketing approval with the US FDA and the European Medicines Agency (EMA).