Safety and efficacy of Stivant® – The new biosimilar of bevacizumab in Iran

Purpose: The purpose of this study was to evaluate the efficacy and safety profile of intravitreal injection of bevacizumab biosimilar (Stivant) for various retinal neovascular conditions. Methods: Prospective analysis was carried out on 385 injections which were administered with intravitreal Stivant® injection in Farabi Eye Hospital in Iran. The injections were administered for various indications such as wet age related macular degeneration (AMD), diabetic macular edema (DME), and retinal vein occlusion (RVO).Results: The mean age of the patients was 61.7 ± 7.20 years. A total of 55.1%% injections were administered to men and 44.9% to women. The indications for which the injection was administered were DME (61%), AMD (22 %), and RVO (17%). Mean pretreatment BCVA was 0.67 ± 0.41 logMAR with CMT 425 ± 54.9 μm μm and postinjection BCVA at day 30 was 0.57 ± 0.37 logMAR with CMT reducing to 312.20 ± 40.81 μm, indicating statistical significance (P = 0.01 and P < 0.001, respectively) for all groups. Among the ocular side effects, none of the patients were reported with severe inflammation, endophthalmitis or rise in intraocular pressure (IOP) > 21 mm of Hg during 3 months follow up period post injections. No systemic adverse events were noted in study population. Conclusion: Intravitreal injection of Stivant® (biosimilar of Bevacizumab) was tolerated well over a period of three months with improvement in BCVA and CMT. This prospective analysis suggests this biosimilar can be effective and safe in the management of various retinal neovascular conditions as well.