Abstract :
Purpose: To report the clinical efficacy and safety of the intravitreal ranibizumab biosimilar molecule, Razumab® (IVRz) as an economic alternative to the innovator molecule (Lucentis) in macular diseases under real-world conditions.
Materials and Methods : A single? center, prospective study of 100 consecutive eyes undergoing three-monthly IVRz between April 2020 to March 2021 for a variety of macular disorders including diabetic macular edema (DME), neovascular age?related macular degeneration (nAMD), retinal vein occlusion (RVO), and myopic choroidal neovascular membrane (mCNVM). The main outcome measures were changes in best-corrected visual acuity (BCVA), central subfield thickness (CST), intraretinal-fluid (IRF), and subretinal-fluid (SRF) along with a safety analysis at weeks 4, 8, and 12 respectively.
Results: Of the 100 eyes of 100 patients undergoing IVRz, a majority had DME (39 eyes; 39%) followed by RVO (34 eyes; 34%), nAMD (21 eyes; 21%), and mCNVM (6 eyes; 6%). Mean BCVA improved from baseline to weeks 4, 8, and 12 (P
Conclusions: Our real-world data suggests that IVRz therapy is safe and efficacious for the management of varied macular pathologies. The cost-effectiveness and systemic and ocular safety of this regulatory-approved biosimilar makes it a suitable alternative to the branded drug. Further comparative studies into the benefit-cost analysis of these biosimilar and branded agents are warranted to better understand the health economics of anti-vascular endothelial growth factor (anti-VEGF) therapy in chorioretinal disorders.
Keyword :
Biosimilars, Ranibizumab, Realworld, Razumab, Antivascular endothelial growth factor.