Lupin Limited (Lupin) announced the successful completion of a global Phase 3 clinical study of LUBT010, its biosimilar candidate to Lucentis (Genentech). 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, the company said in a press release.

The Phase 3 study was designed as a global clinical trial, in line with recommendations from the EMA and the FDA, to evaluate the efficacy, safety and immunogenicity of LUBT010 vs Lucentis in patients with wet AMD, the company said. A total of 600 patients from India, United States, EU and Russia were randomized in the study and received either LUBT010 or Lucentis 0.5 mg, administered as an intravitreal injection once a month for 12 months. The data from this Phase 3 study will be part of Lupin’s application for marketing approval with the FDA and the EMA.

Lupin has been marketing its ranibizumab biosimilar in India under the brand name RaniEyes since 2022. Ranibizumab is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment used in the treatment of wet AMD, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy and myopic choroidal neovascularization.