Roles of Faricimab in the Treatment of Neovascular Age-Related Macular Degeneration and Diabetic Macular Edema
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Abstract
Faricimab is a new anti-vascular endothelial growth factor (anti-VEGF) that was registered by the US Food and Drug Administration in 2021. This drug was registered in Thailand in 2022 for the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). Faricimab is the only anti-VEGF drug whose duration of treatment depends on visual acuity assessment and retinal anatomic outcomes leading to the reduced numbers of treatment and expenses. In addition, faricimab is the first anti-VEGF drug developed as a bispecific antibody, allowing it to inhibit both the VEGF pathway and the Ang/Tie pathway. Therefore, its effectiveness is expected to last longer than that of other anti-VEGF drugs that can inhibit only the VEGF pathway. In a phase 3 clinical trial comparing the efficacy and safety of faricimab with aflibercept, a commonly used first-line drug for the treatment of nAMD and DME, faricimab was not inferior to aflibercept as measured by best-corrected visual acuity change from baseline with the extension of dosing duration to 16 weeks. Safety of faricimab was similar to that of aflibercept. However, the efficacy and safety of faricimab should be monitored to maximize treatment outcomes for patients. Faricimab has recently been registered in Thailand, data on its use in the country are therefore limited. This article provides information on faricimab including its general information, dosage, method of administration, efficacy, adverse reactions and guidelines for drug use in Thailand.
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ผลการวิจัยและความคิดเห็นที่ปรากฏในบทความถือเป็นความคิดเห็นและอยู่ในความรับผิดชอบของผู้นิพนธ์ มิใช่ความเห็นหรือความรับผิดชอบของกองบรรณาธิการ หรือคณะเภสัชศาสตร์ มหาวิทยาลัยสงขลานครินทร์ ทั้งนี้ไม่รวมความผิดพลาดอันเกิดจากการพิมพ์ บทความที่ได้รับการเผยแพร่โดยวารสารเภสัชกรรมไทยถือเป็นสิทธิ์ของวารสารฯ
References
National Statistical Office, Ministry of Digital Economy and Society. The 2021 survey of the older persons in Thailand [online]. 2022 [cited Nov 12, 2022]. Available from: www.nso.go.th/sites/2014/.
Anothaisintawee T, Leelahavarong P, Ratanapakorn T, Teerawattananon Y. The use of comparative effectiveness research to inform policy decisions on the inclusion of bevacizumab for the treatment of macular diseases in Thailand's pharmaceutical benefit package. Clinicoecon Outcomes Res. 2012; 4: 361-74.
Abd AJ, Kanwar RK, Kanwar JR. Aged macular degeneration: current therapeutics for management and promising new drug candidates. Drug Discov Today. 2017; 22: 1671-9.
Bowornwattanadilok P. Update diabetic macular edema management. Thammasat Thai Journal of Ophthalmology. 2013; 8: 46-53.
Finger RP, Daien V, Eldem BM, Talks JS, Korobelnik JF, Mitchell P, et al. Anti-vascular endothelial growth factor in neovascular age-related macular degeneration - a systematic review of the impact of anti-VEGF on patient outcomes and healthcare systems. BMC Ophthalmol. 2020; 20: 294.
Adamis AP, Brittain CJ, Dandekar A, Hopkins JJ. Building on the success of anti-vascular endothelial growth factor therapy: a vision for the next decade. Eye (Lond). 2020; 34: 1966-72.
Nguyen QD, Brown DM, Marcus DM, Boyer DS, Patel S, Feiner L, et al. Ranibizumab for diabetic macular edema: results from 2 phase III randomized trials: RISE and RIDE. Ophthalmology. 2012; 119: 789-801.
Brown DM, Schmidt-Erfurth U, Do DV, Holz FG, Boyer DS, Midena E, et al. Intravitreal aflibercept for diabetic macular edema: 100-week results from the VISTA and VIVID studies.Ophthalmology. 2015; 122: 2044-52.
Wells JA, Glassman AR, Ayala AR, Jampol LM, Aiello LP, Antoszyk AN, et al. Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema. N Engl J Med. 2015; 372: 1193-203.
Flaxel CJ, Adelman RA, Bailey ST, Fawzi A, Lim JI, Vemulakonda GA, et al. Age-related macular degeneration preferred practice pattern. Ophthalmology. 2020; 127: 1-65.
Flaxel CJ, Adelman RA, Bailey ST, Fawzi A, Lim JI, Vemulakonda GA, et al. Diabetic retinopathy preferred practice pattern. Ophthalmology. 2020; 127: 66-145.
Jonisch J, Shah G. Diagnosis of age-related macular degeneration. In: Ho AC, Regillo CD, editors. Age-related macular degeneration diagnosis and treatment. New York: Springer; 2011. p. 23-38.
Steinle N, Kaiser PK. Combination therapy with ocular photodynamic therapy for age-related macular degeneration. In: Ho AC, Regillo CD, editors. Age-related macular degeneration diagnosis and treatment. New York: Springer; 2011. p. 99-118.
Powers AC, Stafford JM, Rickels MR. Diabetes mellitus: complications. In: Loscalzo J, Fauci AS, Kasper DL, Hauser SL, Longo DL, Jameson JL, editors. Harrison's Principles of Internal Medicine. 21st ed. New York: Mcgraw Hill; 2022. p. 3120-36.
Das A, McGuire PG, Rangasamy S. Diabetic macular edema: pathophysiology and novel therapeutic targets. Ophthalmology. 2015; 122: 1375-94.
Liberski S, Wichrowska M, Kociecki J. Aflibercept versus faricimab in the treatment of neovascular age-related macular degeneration and diabetic macular edema: a review. Int J Mol Sci. 2022; 23: 9424.
Khan M, Aziz AA, Shafi NA, Abbas T, Khanani AM. Targeting angiopoietin in retinal vascular diseases: a literature review and summary of clinical trials involving faricimab. Cells. 2020; 9: 1869.
Smith AG, Kaiser PK. Emerging treatments for wet age-related macular degeneration. Expert Opin Emerg Drugs. 2014; 19: 157-64.
Shirley M. Faricimab: First approval. Drugs. 2022; 82: 825-30.
Regula JT, Lundh von Leithner P, Foxton R, Barathi VA, Gemmy Cheung CM, Bo Tun SB, et al. Targeting key angiogenic pathways with a bispecific CrossMAb optimized for neovascular eye diseases. EMBO Mol Med. 2017; 9: 1265-88.
Genentech. Vabysmo [online]. 2022 [cited Oct 14, 2022]. Available from: www.gene.com/download/pdf /vabysmo_prescribing.pdf.
Drug.com. Pegaptanib Information from Drugs.com; c2000-2023 [updated Dec 2, 2022; cited Jan 5, 2023]. Available from: www.drugs.com/history/macugen.html.
Hussain RM, Shaukat BA, Ciulla LM, Berrocal AM, Sridhar J. Vascular endothelial growth factor antagonists: promising players in the treatment of neovascular age-related macular degeneration. Drug Des Devel Ther. 2021; 15: 2653-65.
Blinder KJ, Dugel PU, Chen S, Jumper JM, Walt JG, Hollander DA, et al. Anti-VEGF treatment of diabetic macular edema in clinical practice: effectiveness and patterns of use (ECHO Study Report 1). Clin Ophthalmol. 2017; 11: 393-401.
Heier JS, Khanani AM, Quezada Ruiz C, Basu K, Ferrone PJ, Brittain C, et al. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials. Lancet. 2022; 399: 729-40.
Khanani AM, Guymer RH, Basu K, Boston H, Heier JS, Korobelnik JF, et al. TENAYA and LUCERNE: Rationale and design for the phase 3 clinical trials of faricimab for neovascular age-related macular degeneration. Ophthalmol Sci. 2021; 1: 100076.
Wykoff CC, Abreu F, Adamis AP, Basu K, Eichen baum DA, Haskova Z, et al. Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with diabetic macular oedema (YOSEMITE and RHINE): two randomised, double-masked, phase 3 trials. Lancet. 2022; 399: 741-55.
Eter N, Singh RP, Abreu F, Asik K, Basu K, Baumal C, et al. YOSEMITE and RHINE: Phase 3 randomized clinical trials of faricimab for diabetic macular edema: study design and rationale. Ophthal mol Sci. 2022; 2: 100111.
MICROMEDEX® [Database on the internet]. Colorado: Thomson Reuters (Healthcare); c1974-2022. DRUGDEX® System, Faricimab. 2022 [cited Sep 19, 2022]. Available from: www.micromedexsolutions.com Subscription required to view.
American Society of Retina Specialists. 2020 Global trends in retina survey [online]. 2020 [cited Oct 12, 2022]. Available from: www.asrs.org/sections/inter -national/global-trends-in-retina.
Zhang J, Zhang J, Zhang C, Zhang J, Gu L, Luo D, et al. Diabetic macular edema: current understanding, molecular mechanisms and therapeutic implications. Cells. 2022; 11: 3362.
Chongtrakul P, Sumpradit N, Yoongthong W. ISafE and the evidence-based approach for essential medicines selection in Thailand. Essent Drugs Monit 2005; 34: 18-9.
Laoharuangchaiyot J, Kapol N. Review of access to high-cost essential medicines through drug selection process of the National List of Essential Medicines in Thailand: subcategory E (2). Journal of Health Systems Research. 2021; 15: 1-22.
MICROMEDEX® [Database on the internet]. Colorado: Thomson Reuters (Healthcare); c1974-2022. DRUGDEX® System, Aflibercept. [cited Dec 30,
. Available from: www.micromedexsolutions.com Subscription required to view.
MICROMEDEX® [Database on the internet]. Colorado: Thomson Reuters (Healthcare); c1974-2022. DRUGDEX® System, Bevacizumab. [cited Dec 30,
. Available from: www.micromedexsolutions.com Subscription required to view.
Uptodate [Internet]. MA: Wolters Kluwer; c2022. Faricimab; [cited Dec 30, 2022]. Available from: www.uptodate.com/contents/faricimab-drug-information? search=faricimab&source=panel_search_result&selectedTitle=1~3&usage_type=panel&kp_tab=drug_general&display_rank=1.
Uptodate [Internet]. MA: Wolters Kluwer; c2022. Bevacizumab; [cited Dec 30, 2022]. Available from: www.uptodate.com/contents/bevacizumab-including-biosimilars-drug-information?search=bevacizumab& source=panel_search_result&selectedTitle=1~148&
usage_type=panel&kp_tab=drug_general&display_
rank=1.
Uptodate [Internet]. MA: Wolters Kluwer; c2022. Aflibercept; [cited Dec 30, 2022]. Available from: www.uptodate.com/contents/aflibercept-ophthalmic-drug-information?search=aflibercept&source=panel_ search_result&selectedTitle=1~28&usage_type=panel&showDrugLabel=true&display_rank=1.
Ministry of Public Health. National drug information: Median price [online]. 2019 [cited Dec 30, 2022].
Available from: ndi.fda. moph.go.th/ drug _value
/index/public/.
National Drug Information. National List of Essential Medicines category E(2) [online]. 2019 [cited Jan 5, 2023]. Available from: ndi.fda.moph.go.th/drug_national.
Nair AA, Finn AP, Sternberg P, Jr. Spotlight on faricimab in the treatment of wet age-related macular degeneration: design, development and place in therapy. Drug Des Devel Ther. 2022; 16: 3395-400.