Ranibizumab, combined with photodynamic therapy, to control abnormal growth of blood vessels in NVAMD is the gold standard in many countries; however, other treatment options with various VEGF inhibitors are also widely used. This medication is only available by prescription from a physician. Mechanism of Action
Full Answer
What is the purpose of using ranibizumab?
Ranibizumab injection (Lucentis) is used to treat wet age-related macular degeneration (AMD; an ongoing disease of the eye that causes loss of the ability to see straight ahead and may make it more difficult to read, drive, or perform other daily activities).
Why is ranibizumab better than bevacizumab?
Bevacizumab has a longer half-life in the systemic circulation than ranibizumab while ranibizumab is believed to penetrate the retina better and has higher affinity to VEGF-A than bevacizumab. These differences could have an impact on safety and efficacy of these drugs [4].
What is ranibizumab injection?
LUCENTIS® (ranibizumab injection) is a prescription medicine for the treatment of patients with: wet age-related macular degeneration (wAMD) macular edema following retinal vein occlusion (RVO) diabetic macular edema (DME)
What is ranibizumab and bevacizumab?
Currently, Ranibizumab (Lucentis) and Bevacizumab (Avastin) are two major anti-VEGF drugs for the treatment of AMD. Ranibizumab was licensed by FDA in June 2006, while Bevacizumab with similar molecular structure to Ranibizumab has also been proved to be highly effective for AMD.
Is ranibizumab anti VEGF?
In ophthalmology, intravitreal ranibizumab, bevacizumab, and aflibercept are the most commonly used anti-VEGF treatments for retinal disease.
Is ranibizumab glycosylated?
First, Bevacizumab (149 kDa) and Ranibizumab (48.39 kDa) have different molecular weights, mainly because Ranibizumab does not contain an Fc part; second, Bevacizumab is produced in a eukaryotic cell line (CHO cells) and is N-glycosylated in its Fc region, while Ranibizumab is produced in prokaryotic E.
Is ranibizumab a biologic?
Razumab is available at 30% discount compared to reference biologic ranibizumab in India and is the only similar biologic to ranibizumab being used clinically. Aflibercept has gained the market share in Europe and the US significantly in recent past.
What is ranibizumab Ophthalmology?
Ranibizumab ophthalmic (for the eyes) is used to treat the "wet form" of age-related macular degeneration. Ranibizumab is also used to treat swelling in the retina caused by diabetes or by a blockage in the blood vessels.
Is ranibizumab a protein?
Protein drugs that neutralize vascular endothelial growth factor (VEGF), such as aflibercept or ranibizumab, rescue vision in patients with retinal vascular diseases.
What is Avastin made from?
Avastin contains bevacizumab, a recombinant humanised monoclonal antibody produced by DNA technology. The applicant sought a marketing authorisation for Avastin in combination with 5- fluorouracil/folinic acid containing regimens for the first-line treatment of patients with metastatic carcinoma of the colon or rectum.
Who makes Macugen?
Approval of Macugen, developed by Eyetech Pharmaceuticals Inc. and Pfizer Inc., follows a priority review under the FDA's rolling submission-Pilot 1 program based on data from the companies' Phase II/III pivotal clinical trials.
What company makes eylea?
Aflibercept, sold under the brand names Eylea and Zaltrap, is a medication used to treat wet macular degeneration and metastatic colorectal cancer. It was developed by Regeneron Pharmaceuticals and is approved in the United States and the European Union.
Is vegf used for nvAMD?
The anti-VEGF agents, ranibizumab and bevacizumab, are both widely used in the treatment of nvAMD although bevacizumab has not yet received regulatory approval for intraocular use . Bevacizumab costs considerably less than ranibizumab when administered as an intraocular injection, which has led to widespread use and studies comparing the efficacy and safety of the two drugs. Bevacizumab shares identical pharmacology with ranibizumab although structural differences result in differences in receptor affinity and rates of drug clearance. While estimates of the vitreous half-life of ranibizumab vary, it is shorter than that of bevacizumab. Furthermore, the serum half-life of bevacizumab is about 20 days, more than twice that of ranibizumab and this has led to speculation that it may present a greater risk of systemic adverse effects. Considerable clinical trial evidence exists relating to the efficacy and safety of ranibizumab. The Comparison of age-related macular degeneration treatments trials (CATT) study of the two drugs found efficacy to be equivalent for the as needed versus as needed and monthly versus monthly comparisons. Ranibizumab as needed was equivalent to monthly ranibizumab, though the bevacizumab as needed was not equivalent to monthly bevacizumab. A greater number of serious adverse events (SAEs) occurred with bevacizumab. However, the study was insufficiently powered to identify differences in drug-related adverse events. Intravitreal injection of bevacizumab is associated with a low but significant risk of acute intraocular inflammation, shown to result in significant visual loss in some patients. Finally, there are issues related to fractionating of bevacizumab that has lead to sporadic cases of blindness worldwide. The increased risk for both systemic and ocular adverse events may influence the cost-effectiveness ratio of the two drugs based on health economic models. Further comparative studies and continuous monitoring of safety data are required to examine the incidence of adverse events.#N#Acknowledgement: Editorial Assistance was provided by Touch Briefings.#N#Support: During the peer review process, Novartis Pharma AG (Basel) and Genentech Inc (CA) were offered an opportunity to comment on this article. Changes resulting from comments received were made by the authors on the basis of scientific and editorial merit.
Is ranibizumab safe for AMD?
There is extensive robust and consistent evidence to support the efficacy and safety of ranibizumab in nvAMD. Data suggest that bevacizumab provides efficacy in wet AMD, but the safety profile of intravitreal bevacizumab remains to be established. There is the possibility of greater systemic effects of bevacizumab, possibly be due to its longer systemic half life after administration. There are also data to suggest that bevacizumab may have a higher risk of incidence of severe intraocular inflammation and ATEs. This incremental risk for systemic and ocular adverse events may influence the cost-effectiveness ratio based on health economic models that directly compare one anti-VEGF agent to the other.#N#Head-to-head studies including CATT show non-inferiority in VA when both drugs are given monthly (but not PRN), but these studies may not be powered for safety, particularly for rare but possibly fatal events such as ATEs. Even if all data are pooled from main head-to-head studies this will still be insufficient to detect safety differences between ranibizumab and bevacizumab. Continuous monitoring of safety data in postmarketing will be important to examine the incidence of adverse events.
Abstract
Background: The discussion on the use of bevacizumab is still ongoing and often doctors are deterred from using bevacizumab due to legal or political issues. Bevacizumab is an effective, safe and inexpensive treatment option for neovascular age-related macular degeneration (AMD), albeit unregistered for the disease.
Substances
This study was made possible by a grant awarded to the research project “Toward personalized medicine in patients with age-related macular degeneration” by the Radboud Institute for Health Sciences (grant 016.096.309) (FvA). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
