Clinical effectiveness and safety of razumab (a biosimilar of ranibizumab)

Abstract

Context: This study was done to evaluate the effectiveness and safety of biosimilar Razumab for the treatment of diabetic macular edema (DME), neovascular age related macular degeneration (ARMD), and cystoid macular edema (CME) due to retinal vein occlusions (RVOs) and to assess the central foveal thickness (CFT) and LogMAR best corrected visual acuity(BCVA) post Intravitreal Anti- VEGF Razumab at the end of 1 month from the baseline values. Aims: The purpose of this study was to evaluate the safety and efficacy of intravitreal biosimilar Razumab© in the treatment of wet ARMD, DME, and RVOs. Settings and Design: This was a retrospective, observational study which was conducted in a tertiary eye care institute in Tamil Nadu. Subjects and Methods: Three hundred and nine patients having active or previously treated retinal vascular conditions including neovascular ARMD, DME, and CME due to RVO were subjected to best-corrected visual acuity (BCVA) using LogMAR charts, Goldmann applanation tonometry to measure intraocular pressures, slit-lamp biomicroscopy, indirect ophthalmoscopy, color fundus photography, and spectral-domain optical coherence tomography at baseline and 1 month postintravitreal injection Razumab©, respectively. Statistical Analysis Used: Microsoft Excel was used to enter the data of the findings, and the analysis was done using SPSS 22 version software (IBM, SPSS Inc.,Chicago,IL). Frequencies and proportions were used to enter the categorical data. Chi-square was used as a test of significance. Continuous data were represented as mean and standard deviation. BCVA and CFT data were analyzed using two-tailed paired t-test. Paired t-test is the test of significance for paired data such as before and after injection. P < 0.05 was considered statistically significant. Results: There was a significant improvement in visual acuity and a marked reduction in CFT at the end of 1 month from the baseline values collectively and in each disease pathology. Conclusions: Our study revealed the short-term result of the efficacy of Razumab©, the biosimilar of ranibizumab, as an effective treatment alternative in the management of wet ARMD, DME, and RVO by reducing CFT and improving visual acuity. However, long-term follow-up and repeat injections are required to determine its long-term safety and efficacy.

Keywords

• antivascular endothelial growth factor
• biosimilar
• diabetic macular edema
• ranibizumab
• razumab
• retinal vein occlusions
• wet armd