Brolucizumab, sold under the trade name Beovu, is a humanized single-chain antibody fragment for the treatment of neovascular age-related macular degeneration. The most common side effects are reduced visual acuity, cataract, conjunctival haemorrhage and vitreous floaters. The most serious side effects are blindness, endophthalmitis, retinal artery occlusion and retinal detachment. Brolucizumab was designed to attach to and block a substance called vascular endothelial growth factor A. VEGF-A is a protein that makes blood vessels grow and leak fluid and blood, damaging the macula. By blocking VEGF-A, ranibizumab reduces the growth of the blood vessels and controls the leakage and swelling.
History
This drug was developed by ESBATech, Alcon Laboratories, and Novartis. Brolucizumab is U.S. Food and Drug Administration approved in ophthalmology as Beovu. Brolucizumab successfully completed phase III development in wet age-related macular degeneration meeting the primary efficacy endpoint of non-inferiority to aflibercept in mean change in best corrected visual acuity 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 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 with uncompromised efficacy. The FDA approved Beovu based on evidence from two clinical trials 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 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.
Safety concerns
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. Novartis responded with a statement standing behind the efficacy of Beovu. 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 and HARRIER clinical trials and noted in the original prescribing information.
