Ranibizumab

In the United States, ranibizumab is indicated for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization. Its effectiveness is similar to that of bevacizumab and aflibercept. A 2023 systematic review update found that while ranibizumab and bevacizumab provide similar functional outcomes in diabetic macular edema, there is low-certainty evidence suggesting that ranibizumab is more effective in reducing central retinal thickness than bevacizumab. Susvimo is a reformulation of ranibizumab suitable for injection via ocular implant. Susvimo was approved for medical use in the United States in October 2021. == Side effects ==

A 2014 Cochrane review did not find a difference between bevacizumab and ranibizumab in deaths or total severe side effects when used for macular degeneration. There, however, was not a lot of evidence, and thus this conclusion is not that certain. Serious adverse events related to the injection procedure occurred with an incidence rate of less than 1% and included endophthalmitis, retinal detachment, and traumatic cataracts. Other serious ocular adverse events observed among ranibizumab-treated patients (incidence rate < 1%) included intraocular inflammation and blindness. == Interactions ==

No significant interactions are known. ==Pharmacology==

Ranibizumab is a monoclonal antibody that inhibits angiogenesis by inhibiting vascular endothelial growth factor A, a mechanism similar to that of bevacizumab. == Society and culture ==

Legal status Biosimilars Byooviz was authorized for medical use in the European Union in August 2021. Ranibizumab-nuna (Byooviz) was approved for medical use in the United States in September 2021. In India, Lupin Limited received marketing approval for its biosimilar of Ranibizumab. In June 2022, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Ranivisio, intended for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to macular edema or choroidal neovascularization, and proliferative diabetic retinopathy. Ranivisio was authorized for medical use in the European Union in August 2022. Ranibizumab-eqrn (Cimerli) was approved for medical use in the United States in August 2022. In September 2022, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Ximluci, intended for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to diabetic macular edema, proliferative diabetic retinopathy, visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO or central RVO), and visual impairment due to choroidal neovascularization. Ximluci was authorized for medical use in the European Union in November 2022. In November 2023, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Rimmyrah, intended for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to diabetic macular edema, proliferative diabetic retinopathy, visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO or central RVO), and visual impairment due to choroidal neovascularization. Rimmyrah is a biosimilar medicinal product that is highly similar to the reference product Lucentis (ranibizumab), which was authorized in the EU in January 2007. In January 2024, Sandoz signed an agreement to acquire ranibizumab-eqrn, the biosimilar version of ranibizumab branded as Cimerli from Coherus BioSciences, Inc. for an upfront cash purchase payment of . In July 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Epruvy, intended for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to diabetic macular edema, proliferative diabetic retinopathy, visual impairment due to macular edema secondary to retinal vein occlusion and visual impairment due to choroidal neovascularization. Epruvy was authorized for medical use in the European Union in September 2024. Ranibizumab-leyk (Nufymco) was approved for medical use in the United States in December 2025. Economics Its effectiveness is similar to that of bevacizumab. Its rates of side effects also appear similar. A small study showed no superior effect of ranibizumab versus bevacizumab in direct comparison. The initial results of the larger Comparison of Age-related Macular Degeneration Treatments Trials (CATT) found that the two drugs "had equivalent effects on visual acuity when administered according to the same schedule;" however, serious adverse events were more common in the bevacizumab arm of the trial. According to a 2012 meta-analysis, the results of several subsequent head-to-head trials found that the two therapies performed equally at restoring visual acuity. A 2012 meta-analysis focused specifically on safety issues concluded that the rates of several adverse events were higher with bevacizumab, although the absolute rates of ocular serious adverse events were low with both therapies: ocular adverse events were about 2.8 times as frequent with bevacizumab than with ranibizumab. == References ==