Brolucizumab: Evaluation of Compassionate Use of a Complex Anti-VEGF Therapy

References

• Tadayoni R, Sararols L, Weissgerber G, Verma R, Clemens A, Holz FG. Brolucizumab: a newly developed Anti-VEGF molecule for the treatment of neovascular age-related macular degeneration. Ophthalmologica. 2020;244:93–101. doi:10.1159/000513048
   Web of Science ®Google Scholar
• Patel NA, Berrocal AM, Murray TG, Villegas VM. Advanced Coats’ disease treated with intravitreal brolucizumab combined with laser photocoagulation. Am J Ophthalmol Case Rep. 2020;19:eCollection. doi:10.1016/j.ajoc.2020.100815
   Google Scholar
• Rispoli M, Eandi CM, Di Antonio L, Kilian R, Montesel A, Savastano MC. Biomarkers in early response to brolucizumab on pigment epithelium detachment associated with exudative age-related macular degeneration. Biomedicines. 2021;9(6):668. doi:10.3390/biomedicines9060668
   PubMed Web of Science ®Google Scholar
• Yu JS, Carlton R, Agashivala N, Hassan T, Wykoff CC. Brolucizumab vs aflibercept and ranibizumab for neovascular age-related macular degeneration: a cost-effectiveness analysis. J Manag Care Spec Pharm. 2021;27(6):743–752. doi:10.18553/jmcp.2021.27.6.743
   PubMed Web of Science ®Google Scholar
• Singer M, Albini TA, Seres A, et al. Clinical characteristics and outcomes of eyes with intraocular inflammation after brolucizumab: post hoc analysis of HAWK and HARRIER. Ophthalmol Retina. 2021. doi:10.1016/j.oret.2021.05.003
   Google Scholar
• Ogura Y, Jaffe GJ, Cheung CMG, et al. Efficacy and safety of brolucizumab versus aflibercept in eyes with polypoidal choroidal vasculopathy in Japanese participants of HAWK. Br J Ophthalmol. 2021. doi:10.1136/bjophthalmol-2021-319090
   Web of Science ®Google Scholar
• Sacconi R, Giuffrè C, Corbelli E, Borrelli E, Querques G, Bandello F. Emerging therapies in the management of macular edema: a review. F1000Research. 2019;8:1413. doi:10.12688/f1000research.19198.1
   Google Scholar
• European Medicines Agency: EMA/MB/69923/2010 – annual report of the European Medicines Agency; 2009. Available from: https://www.ema.europa.eu/en/documents/annual-report/annual-report-european-medicines-agency-2009_en.pdf. Accessed December 8, 2021.
   Google Scholar
• Nguyen QD, Das A, Do DV, et al. Brolucizumab: evolution through preclinical and clinical studies and the implications for the management of neovascular age-related macular degeneration. Ophthalmology. 2020;127(7):963–976. doi:10.1016/j.ophtha.2019.12.031
   PubMed Web of Science ®Google Scholar
• Baumal CR, Bodaghi B, Singer M, et al. Expert opinion on management of intraocular inflammation, retinal vasculitis, and vascular occlusion after brolucizumab treatment. Ophthalmol Retina. 2021;5(6):519–527. doi:10.1016/j.oret.2020.09.020
   PubMedGoogle Scholar
• Cox JT, Eliott D, Sobrin L. Inflammatory complications of intravitreal anti-VEGF injections. J Clin Med. 2021;10(5):981. doi:10.3390/jcm10050981
   PubMed Web of Science ®Google Scholar
• Anderson WJ, da Cruz NFS, Lima LH, Emerson GG, Rodrigues EB, Melo GB. Mechanisms of sterile inflammation after intravitreal injection of antiangiogenic drugs: a narrative review. Int J Retina Vitreous. 2021;7(1):37. doi:10.1186/s40942-021-00307-7
   PubMedGoogle Scholar
• Dugel PU, Singh RP, Koh A, et al. HAWK and HARRIER: ninety-six-week outcomes from the Phase 3 trials of brolucizumab for neovascular age-related macular degeneration. Ophthalmology. 2021;128(1):89–99. doi:10.1016/j.ophtha.2020.06.028
   PubMed Web of Science ®Google Scholar
• Witkin AJ, Hahn P, Murray TG, et al. Occlusive retinal vasculitis following intravitreal brolucizumab. J Vitreoretin Dis. 2020;4(4):269–279. doi:10.1177/2474126420930863
   PubMedGoogle Scholar
• Bell JS, Richards GC. Off-label medicine use: ethics, practice and future directions. Aust J Gen Pract. 2021;50(5):329–331. doi:10.31128/AJGP-08-20-5591
   Web of Science ®Google Scholar
• Bilgic A, Kodjikian L, March de Ribot F, et al. Real-world experience with brolucizumab in wet age-related macular degeneration: the REBA Study. J Clin Med. 2021;10(13):2758. doi:10.3390/jcm10132758
   PubMed Web of Science ®Google Scholar
• Monés J, Srivastava SK, Jaffe GJ, et al. Risk of inflammation, retinal vasculitis, and retinal occlusion-related events with brolucizumab: post hoc review of HAWK and HARRIER. Ophthalmology. 2021;128(7):1050–1059. doi:10.1016/j.ophtha.2020.11.011
   PubMed Web of Science ®Google Scholar
• Dugel PU, Koh A, Ogura Y, et al. HAWK and HARRIER: phase 3, multicenter, randomized, double-masked trials of brolucizumab for neovascular age-related macular degeneration. Ophthalmology. 2020;127(1):72–84. doi:10.1016/j.ophtha.2019.04.017
   PubMed Web of Science ®Google Scholar
• Baumal CR, Spaide RF, Vajzovic L, et al. Retinal vasculitis and intraocular inflammation after intravitreal injection of brolucizumab. Ophthalmology. 2020;127(10):1345–1359. doi:10.1016/j.ophtha.2020.04.017
   PubMed Web of Science ®Google Scholar
• Agostini H, Mulyukov Z, Tsilimbaris M, et al. Comparison of the efficacy of brolucizumab with natural disease progression in wet AMD using clinical data from the Phase III HAWK and HARRIER trials and modelled placebo data. Curr Eye Res. 2020;45(10):1298–1301. doi:10.1080/02713683.2020.1731832
   PubMed Web of Science ®Google Scholar
• Iyer PG, Albini TA. Drug-related adverse effects of antivascular endothelial growth factor agents. Curr Opin Ophthalmol. 2021;32(3):191–197.
   PubMed Web of Science ®Google Scholar
• Enríquez AB, Baumal CR, Crane AM, et al. Early experience with brolucizumab treatment of neovascular age-related macular degeneration. JAMA Ophthalmol. 2021;139(4):441–448. doi:10.1001/jamaophthalmol.2020.7085
   PubMed Web of Science ®Google Scholar
• Bulirsch LM, Saßmannshausen M, Nadal J, Liegl R, Thiele S, Holz FG. Short-term real-world outcomes following intravitreal brolucizumab for neovascular AMD: SHIFT. Br J Ophthalmol. 2021. doi:10.1136/bjophthalmol-2020-318672
   Web of Science ®Google Scholar
• Haensli C, Pfister IB, Garweg JG. Switching to brolucizumab in neovascular age-related macular degeneration incompletely responsive to ranibizumab or aflibercept: real-life 6 month outcomes. J Clin Med. 2021;10(12):2666. doi:10.3390/jcm10122666
   PubMed Web of Science ®Google Scholar
• Dugel PU, Jaffe GJ, Sallstig P, et al. Brolucizumab versus aflibercept in participants with neovascular age-related macular degeneration: a randomized trial. Ophthalmology. 2017;124(9):1296–1304. doi:10.1016/j.ophtha.2017.03.057
   PubMed Web of Science ®Google Scholar
• Kulikov AN, Sosnovskii SV, Berezin R, et al. Vitreoretinal interface abnormalities in diabetic macular edema and effectiveness of anti-VEGF therapy: an optical coherence tomography study. Clin Ophthalmol. 2017;11:1995–2002. doi:10.2147/OPTH.S146019
   PubMed Web of Science ®Google Scholar
• Ashkenazy N, Henry CR, Abbey AM, McKeown CA, Berrocal AM, Murray TG. Successful treatment of juvenile xanthogranuloma using bevacizumab. J AAPOS. 2014;18(3):295–297. doi:10.1016/j.jaapos.2014.01.007
   Web of Science ®Google Scholar
• Sisk RA, Berrocal AM, Albini TA, Murray TG. Bevacizumab for the treatment of pediatric retinal and choroidal diseases. Ophthalmic Surg Lasers Imaging. 2010;41(6):582–592. doi:10.3928/15428877-20100830-03
   Google Scholar
• Graversen VK, Hamichi SE, Gold A, Murray TG. History through the eyes of a pandemic. Curr Opin Ophthalmol. 2020;31(6):538–548. doi:10.1097/ICU.0000000000000711
   Web of Science ®Google Scholar
• Eguale T, Buckeridge DL, Verma A, et al. Association of off-label drug use and adverse drug events in an adult population. JAMA Intern Med. 2016;176(1):55–63. doi:10.1001/jamainternmed.2015.6058
   PubMed Web of Science ®Google Scholar
• Eguale T, Verma A, Tamblyn R. In defense of off-label prescribing-reply. JAMA Intern Med. 2016;176(6):861–862. doi:10.1001/jamainternmed.2016.1406
   Web of Science ®Google Scholar
• Gazarian M, Kelly M, McPhee JR, Graudins LV, Ward RL, Campbell TJ. Off-label use of medicines: consensus recommendations for evaluating appropriateness. Med J Aust. 2006;185(10):544–548. doi:10.5694/j.1326-5377.2006.tb00689.x
   PubMed Web of Science ®Google Scholar
• Murray TG, Berrocal AM. Ethics in the practice of retina. Retin Physician. 2019;54:67–78.
   Google Scholar
• Radley DC, Finkelstein SN, Stafford RS. Off-label prescribing among office-based physicians. Arch Intern Med. 2006;166(9):1021–1026. doi:10.1001/archinte.166.9.1021
   PubMed Web of Science ®Google Scholar
• Gopal AD, Wallach JD, Shah SA, Regillo C, Ross JS. On-label and off-label clinical studies of FDA-approved ophthalmic therapeutics. Ophthalmology. 2021;128(2):332–334. doi:10.1016/j.ophtha.2020.07.028
   Web of Science ®Google Scholar
• Borysowski J, Ehni HJ, Górski A. Ethics codes and use of new and innovative drugs. Br J Clin Pharmacol. 2019;85(3):501–507. doi:10.1111/bcp.13833
   PubMed Web of Science ®Google Scholar
• Brown DM, Wolf S, Garweg J, et al. Brolucizumab for the treatment of visual impairment due to diabetic macular edema: 52-week results from the KITE and KESTREL studies. Invest Ophthalmol Vis Sci. 2021;62(8):1045.
   Web of Science ®Google Scholar