|Type||Single-chain variable fragment|
|Target||Vascular endothelial growth factor A (VEGFA)|
|Trade names||Beovu, Vsiqq|
|Other names||Brolucizumab-dbll, ESBA1008, RTH258, DLX1008|
|Main uses||Wet age-related macular degeneration (AMD)|
|Side effects||Reduced visual acuity, cataracts, conjunctival bleeding, floaters|
|Chemical and physical data|
|Molar mass||26281.17 g·mol−1|
Common side effects include reduced visual acuity, cataracts, conjunctival bleeding, and floaters. Other side effects may include blindness, infection inside the eye, retinal artery occlusion, and retinal detachment. Use in pregnancy may harm the baby. It is a piece of a monoclonal antibody that attaches to and block vascular endothelial growth factor A (VEGF-A). VEGF-A is a protein that makes blood vessels grow and leak fluid.
Brolucizumab was approved for medical use in the United States in 2019 and Europe in 2020. In the United Kingdom it costs the NHS about £820 per dose as of 2021. This amount in the United States is about 1,950 USD.
On 23 February 2020, the American Society of Retina Specialists reported side effects of the drug, specifically in 14 cases of retinal vasculitis reported in Beovu patients, 11 of the cases were occlusive retinal vasculitis that can lead to vision loss.
On 11 June 2020, the FDA approved an updated Beovu label, that included additional safety information specifically including the characterization of adverse events, retinal vasculitis and retinal vascular occlusion, as part of the spectrum of intraocular inflammation observed in HAWK (NCT02307682) and HARRIER (NCT02434328) clinical trials and noted in the original prescribing information.
Brolucizumab successfully completed phase III development in wet age-related macular degeneration (AMD) meeting the primary efficacy endpoint of non-inferiority to aflibercept in mean change in best corrected visual acuity (BCVA) from baseline to week 48. Furthermore, brolucizumab demonstrated superiority to aflibercept in key secondary endpoint measures of disease activity in wet AMD, a leading cause of blindness in two head-to-head pivotal Phase III studies. 
On 8 October 2019, Novartis announced that the U.S. Food and Drug Administration (FDA) approved brolucizumab injection for the treatment of wet AMD. Beovu is the first FDA approved anti-VEGF to offer both greater fluid resolution versus aflibercept and the ability to maintain eligible wet AMD patients on a three-month dosing interval immediately after a three-month loading phase[failed verification] with uncompromised efficacy.[medical citation needed]
The FDA approved Beovu based on evidence from two clinical trials (Trial 1/ NCT02307682 and Trial 2/NCT02434328) of 1459 patients, 50–97 years old, with wet AMD. The trials were conducted at 336 sites in the United States, Canada, Central and South America, European countries, Israel, Turkey, Australia, New Zealand, Japan, South Korea, Singapore, Taiwan, and Vietnam.
While brolucizumab was initially developed for ophthalmology, non-ophthalmology indications (to which Cell Medica hold development rights) are also under investigation, under the name DLX1008. DLX1008 is under preclinical development for Kaposi sarcoma and glioblastoma.
Brolucizumab was approved for use in the European Union in February 2020.
Laboratory development names were RTH258 (Novartis Compound Code) and ESBA1008 (ESBATech AG).[medical citation needed]
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