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Safety and efficacy of Razumab – The new biosimilar in India: Our experience
VV Sameera, AG Apoorva, Shrinivas Joshi, AS Guruprasad
September-December 2016, 28(3):180-185
The aim of this study was to evaluate the safety and efficacy of biosimilar intravitreal ranibizumab (Razumab) for the treatment of chorioretinal vascular diseases such as diabetic macular edema (DME), neovascular age-related macular degeneration (nAMD), and macular edema secondary to retinal vein occlusions (RVOs).
A prospective analysis was performed on consented patients with DME (Group 1), nAMD (Group 2), and macular edema secondary to RVO (Group 3). All patients received Razumab at baseline. Snellen visual acuity assessment, anterior segment and fundus evaluation, fundus photo, and optical coherence tomography imaging were done at days 0, 1, 7, and 30, respectively. The International Society for Clinical Electrophysiology of Vision standard electroretinography (ERG) was performed at baseline and day 30 (23 eyes who could afford the investigation). Primary and secondary outcome measures were safety parameters that included signs of clinical and ERG toxicity and changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT), respectively.
One hundred and twenty-three eyes of 95 patients received biosimilar intravitreal ranibizumab injection between November 2015 and April 2016. No serious drug-related ocular or systemic adverse events were identified. Mean pretreatment BCVA was 0.67 ± 0.41 logMAR with CMT 345.90 ± 128.84 μm and postinjection BCVA at day 30 was 0.57 ± 0.37 logMAR with CMT reducing to 287.66 ± 90.28 μm, indicating statistical significance (
= 0.001 and
< 0.0001, respectively) for all groups.
The biosimilar intravitreal ranibizumab for DME, nAMD, and macular edema secondary to RVO was tolerated over a month with improvements in BCVA and CMT without detectable ocular and systemic toxicity. While the long-term safety and efficacy remain unknown, these short-term results suggest that biosimilar ranibizumab could become a safe, low-cost therapy for macular diseases.
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