Lupin Reports the P-III Study Completion of LUBT010 (Biosimilar, Lucentis) for Neovascular Age-related Macular Degeneration
Shots:
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Lupin has concluded P-III study evaluating the efficacy, safety & immunogenicity of LUBT010 (0.5mg, intravitreal, QM for 1yr.) vs Lucentis in wet AMD adults (n=600) across India, US, EU & Russia
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The trial met its 1EP, showing therapeutic equivalence in visual acuity improvement plus similarity in safety & immunogenicity b/w both the drugs. Results will form the basis of approval across the US & EU
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Ranibizumab is a recombinant humanized IgG1 kappa isotype mAb intended for treating wet AMD, macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR) & myopic choroidal neovascularization (mCNV)
Ref: Lupin | Image: Lupin
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A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies, FDA, EMA, and biosimilar approvals. He can be contacted at connect@pharmashots.com