Review on the Safety and Efficacy of Brolucizumab for Neovascular Age-Related Macular Degeneration From Major Studies and Real-World Data.

Autor:	Radke NV; The C-MER Drugs and Medical Devices Research and Development Center, Shenzhen, China.; The C-MER (Shenzhen), Dennis Lam Eye Hospital, Shenzhen, Guangdong, China., Mohamed S; Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China., Brown RB; University of Pittsburgh, UPMC Eye Centre, Pittsburgh, PA., Ibrahim I; Singapore Eye Research Institute, Singapore National Eye Centre, Singapore., Chhablani J; University of Pittsburgh, UPMC Eye Centre, Pittsburgh, PA., Amin SV; Department of Ophthalmology and Visual Science, University of Chicago, Chicago, IL., Tsang CW; Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China., Brelen ME; Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China., Raichand NS; Hinsdale Central, Hinsdale, IL., Fang D; Shenzhen Eye Hospital, Jinan University, Shenzhen Eye Institute, Shenzhen, China., Zhang S; Shenzhen Eye Hospital, Jinan University, Shenzhen Eye Institute, Shenzhen, China., Dai H; Department of Ophthalmology, Beijing Hospital, Beijing, China., Chen GLJ; Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China., Cheung CMG; Singapore Eye Research Institute, Singapore National Eye Centre, Singapore., Hariprasad SM; Department of Ophthalmology and Visual Science, University of Chicago, Chicago, IL., Das T; Anant Bajaj Retina Institue-Srimati Kanuri Santhamma Centre for Vitreoretinal Disease, L V Prasad Eye Institute, Hyderabad, Telangana, India., Lam DSC; The C-MER Drugs and Medical Devices Research and Development Center, Shenzhen, China.; The C-MER International Eye Research Center of The Chinese University of Hong Kong (Shenzhen), Shenzhen, China.; The C-MER Dennis Lam and Partners Eye Center, C-MER International Eye Care Group, Hong Kong, China.
Jazyk:	angličtina
Zdroj:	Asia-Pacific journal of ophthalmology (Philadelphia, Pa.) [Asia Pac J Ophthalmol (Phila)] 2023 Mar-Apr 01; Vol. 12 (2), pp. 168-183. Date of Electronic Publication: 2023 Mar 24.
DOI:	10.1097/APO.0000000000000602
Abstrakt:	Frequent antivascular endothelial growth factor injections in neovascular age-related macular degeneration (nAMD) often lead to poor compliance and suboptimal outcomes. A longer-acting agent has been a pressing unmet need until recently. Brolucizumab, an antivascular endothelial growth factor agent, is a single-chain antibody fragment approved by the US Food and Drug Administration (FDA) on October 8, 2019, for treating nAMD. It delivers more molecules at equivalent volumes of aflibercept, thus achieving a longer-lasting effect. We reviewed literature published in English between January 2016 and October 2022 from MEDLINE, PubMed, Cochrane database, Embase, and Google scholar using the keywords: "Brolucizumab, real-world data, intraocular inflammation (IOI), safety, and efficacy". Brolucizumab showed reduced injection frequency, better anatomic outcomes, and noninferior vision gains compared with aflibercept in HAWK and HARRIER studies. However, post hoc studies on brolucizumab revealed a higher-than-expected incidence of IOI, leading to the early termination of 3 studies: MERLIN, RAPTOR, and RAVEN for nAMD, branch retinal vein occlusion, and central retinal vein occlusion, respectively. Contrastingly real-world data showed encouraging outcomes in terms of fewer IOI cases. The subsequent amendment of the treatment protocol resulted in reduced IOI. Thereafter US FDA approved its use in diabetic macular edema on June 1, 2022. Based on major studies and real-world data, this review shows that brolucizumab is effective for treating naive and refractory nAMD. The risk of IOI is acceptable and manageable, but proper preinjection screening and high-vigilance care of IOI are needed. More studies are warranted to evaluate further the incidence, best prevention, and treatment measures for IOI. Competing Interests: J.C.: Consultant/speaker—Salutaris, Erasca, Novartis, Allergan, AcuViz, Ocular Therapeutics, OD-OS. S.M.H.: Consultant/speaker—EyePoint Pharmaceuticals, Allergan, Alimera Sciences, Novartis, Biogen, Bausch & Lomb and Regeneron. C.M.G.C.: speaker/consultant for and grants from—Bayer, Novartis, Roche, Allergan, Topcon, Zeiss, Boehringer Ingelheim; supported by the National Medical Research Council Singapore Open Fund Large Collaborative Grant (NMRC/LCG/004/2018). The remaining authors have no funding or conflicts of interest to declare. (Copyright © 2023 Asia-Pacific Academy of Ophthalmology. Published by Wolters Kluwer Health, Inc. on behalf of the Asia-Pacific Academy of Ophthalmology.)
Databáze:	MEDLINE
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