Novartis receives EC Approval for Beovu, a next-generation anti-VEGF treatment for wet AMD, a leading cause of blindness worldwide
[caption id="attachment_9277" align="aligncenter" width="747"] Press Release[/caption]
- Beovu (brolucizumab)?is the only anti-VEGF treatment?approved in Europe for wet AMD that offers the option to start eligible patients on three-month dosing intervals immediately after the loading phase1
- For the more than 20 million people worldwide who are living with wet AMD, frequent injections are a common reason patients drop off existing treatments2-4
- Approval is based on two head-to-head clinical trials, HAWK and HARRIER, in which Beovu achieved robust vision gains that were non-inferior to aflibercept at year one (primary endpoint)1,5
- Beovu also demonstrated superior fluid resolution versus aflibercept at week 16 and year one (secondary endpoints)1,5
- Beovu [summary of product characteristics] Basel, Switzerland. Novartis: 2020.
- Varano M, et al. Current barriers to treatment for wet age-related macular degeneration (wAMD): findings from the wAMD patient and caregiver survey. Clin Ophthalmol. 2015;9:2243?2250.
- Wong WL, Su X, Li X, et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and met analysis. Lancet Glob Health. 2014;2:106-16.
- Singer M. Advances in the management of macular degeneration. F1000Prime Rep. 2014;6:29.
- Dugel P, Koh A, Ogura Y, et al; HAWK and HARRIER Study Investigators. HAWK and HARRIER: Phase 3, multicenter, randomized, double-masked trials of brolucizumab for neovascular age-related macular degeneration. Ophthalmology. 2020;127(1):72-84.
- Qazi Y, et al. Mediators of ocular angiogenesis. J. Genet. 2009;88(4):495-515.
- National Eye Institute. Facts About Age-Related Macular Degeneration. Available at https://nei.nih.gov/health/maculardegen/armd_facts (link is external). Accessed February 2020.
- Schmidt-Erfurth U, et al. Guidelines for the management of neovascular age-related macular degeneration by the European Society of Retina Specialists (EURETINA). Br J Ophthalmol. 2014;98:1144-1167.
- European Society for Retinal Specialists (EURETINA). Retinal Diseases in Europe: Prevalence, Incidence, and Healthcare Needs. Available at: https://www.euretina.org/downloads/EURETINA_Retinal_Diseases.pdf. Accessed February 2020.
- Arnold J, et al. The role of sub-retinal fluid in determining treatment outcomes in patients with neovascular age-related macular degeneration--a phase IV randomised clinical trial with ranibizumab: the FLUID study. BMC Ophthalmol. 2016;143(4):679-680.
- Data on file. RTH258 Core Data Sheet. Novartis; 2019.
- Beovu [US prescribing information] East Hanover, NJ. Novartis: 2019.
- Beovu [Swissmedic prescribing information] Switzerland. Novartis: 2020.
- Beovu [prescription medicine decision summary] Australia. Novartis: 2020.
- Nimz EL, et al. Intraocular and systemic pharmacokinetics of brolucizumab (RTH258) in nonhuman primates. The Association for Research in Vision and Ophthalmology (ARVO) annual meeting. 2016. Abstract 4996.
- Escher D, et al. Single-chain antibody fragments in ophthalmology. Oral presentation at EURETINA congress. 2015. Abstract.
- Gaudreault J, et al. Preclinical pharmacology and safety of ESBA1008, a single-chain antibody fragment, investigated as potential treatment for age related macular degeneration. ARVO Annual Meeting abstract. Invest Ophthalmol Vis Sci 2012;53:3025. http://iovs.arvojournals.org/article.aspx?articleid=2354604 (link is external). Accessed February 2020.
- Tietz J, et al. Affinity and Potency of RTH258 (ESBA1008), a Novel Inhibitor of Vascular Endothelial Growth Factor A for the Treatment of Retinal Disorders. IOVS. 2015; 56(7):1501.
- Kim R. Introduction, mechanism of action and rationale for anti-vascular endothelial growth factor drugs in age-related macular degeneration. Indian J Ophthalmol. 2007;55(6):413-415.
- World Health Organization. Priority eye diseases: Age-related macular degeneration. Available at http://www.who.int/blindness/causes/priority/en/index7.html (link is external). Accessed February 2020.
- NHS Choices. Macular Degeneration. Available at http://www.nhs.uk/Conditions/Macular-degeneration/Pages/Introduction.aspx (link is external). Accessed February 2020.
- What is metamorphopsia? Available at https://www.healthline.com/health/metamorphopsia (link is external). Accessed February 2020.
- Mitchell J, Bradley C. Quality of life in age-related macular degeneration: a review of the literature. Health Qual Life Outcomes. 2006;4:97.
- van Lookeren Campagne M, et al. Mechanisms of age-related macular degeneration and therapeutic opportunities. J Pathol. 2014; 232(2):151-64. doi: 10.1002/path.4266.