Beovu® (brolucizumab) can improve sight and slow down the deterioration caused by wet AMD, a condition developed by nearly 40,000 people in the UK each year1,2
Eye injections are a source of fear for people living with wet AMD, with nearly 55% regularly feeling anxious before treatment3
Brolucizumab could help minimise treatment burden, with more than 50% of patients maintained on 12-weekly dosing intervals immediately after the loading phase to week 482
London, UK, 03 February, 2021 — Novartis today announced that the National Institute for Health and Care Excellence (NICE) has issued final guidance, also known as Technology Appraisal Guidance (TAG), recommending Beovu® (brolucizumab) as an option in the NHS for the treatment of neovascular (wet) age-related macular degeneration (AMD) in adults.
Sight loss has a significant financial impact, costing the UK economy a staggering £25.2 billion a year, due to the costs of informal care by family and friends, productivity losses, and quality of life impacts4. Macular disease, including wet AMD, is the biggest cause of sight loss in the UK5 with up to 40,000 people developing wet AMD every year1. It is a long-term, degenerative disease that can cause changes in vision, often experienced as gaps or dark spots in the centre of a person’s sight6.
NICE’s guidance was based on findings from the Phase III HAWK and HARRIER clinical trials, in which brolucizumab met the primary endpoint, demonstrating gains in best-corrected visual acuity (BCVA) from baseline that were non-inferior to aflibercept at week 482,7. Approximately 30% of patients treated with brolucizumab gained at least 15 letters at week 482,7. Vision gain was seen as early as four weeks into the trial and sustained over the remainder of the trial2,7.
Results from HAWK and HARRIER also showed that more than 50% of patients on brolucizumab were maintained on a 12-weekly dosing interval (56% in HAWK and 51% in HARRIER) immediately after the loading phase through year one2,7.
“Eye injections are a source of fear and anxiety for people with wet AMD and in these exceptional times, they are more anxious than ever about hospital visits,” said Cathy Yelf, Chief Executive of the Macular Society. “We are delighted that a new treatment option, which has the potential to maintain vision and help minimise the number of hospital visits for people living with this devastating condition, is now available in England and Wales.”
In wet AMD, faulty blood vessels leak fluid and blood in the back of the eye, which can permanently scar the macula8,9. If this fluid is left untreated, central vision will gradually get worse9. Brolucizumab works by suppressing the growth of these abnormal blood vessels, reducing the potential for fluid and blood leaking into the retina2.
“Without treatment, wet AMD can progress rapidly causing significant vision loss, which can make everyday activities such as reading and recognising faces more difficult,” said Professor Faruque Ghanchi, Consultant Ophthalmologist at Bradford Teaching Hospitals NHS Foundation. “We welcome NICE’s guidance recommending brolucizumab, which has shown the potential to maintain vision and help minimise the number of hospital visits for people living with this devastating condition. Minimising treatment burden is more important than ever during these unprecedented times.”
In fluid-related secondary clinical endpoints, significantly fewer brolucizumab-treated patients had intra-retinal and/or sub-retinal fluid (IRF/SRF) compared to aflibercept at week 48 (31% for brolucizumab 6 mg vs. 45% for aflibercept in HAWK [P<0.001]; 26% vs. 44%, respectively, in HARRIER) [P<0.001]2. Presence of IRF and SRF may disrupt the normal retinal structure and cause damage to the macula2.
Additionally, brolucizumab showed significantly greater reductions in central subfield thickness compared with aflibercept at week 16 and at week 48. In both trials, 30% fewer patients had signs of disease activity with brolucizumab versus aflibercept as early as week 16 (24% for brolucizumab 6mg vs. 35% for aflibercept in HAWK [P=0.001]; 23% vs. 32%, respectively, in HARRIER) [P=0.002]2. Brolucizumab exhibited an overall well tolerated safety profile in treated patients2.
“NICE’s guidance represents an important development for people in England and Wales living with wet AMD. This decision not only means people with wet AMD have access to a treatment option that has the potential to maintain their vision, but also offers to help minimise treatment burden and hospital visits,” said Chinmay Bhatt, Managing Director UK, Ireland & Nordics for Novartis Pharmaceuticals. “This is more vital than ever to help relieve pressure on healthcare systems. We are working closely with the NHS to ensure eligible patients can start benefiting from brolucizumab as soon as possible.”
Notes to Editors
About NICE’s Technology Appraisal Guidance (TAG)
In December 2020, NICE issued a Final Appraisal Determination (FAD), the final draft guidance recommending Beovu® (brolucizumab) for the treatment of wet AMD in adults. Following a consultation period of three weeks, the final recommendations have now been issued as NICE Technology Appraisal guidance. The NHS now has 30 days to make Beovu available for adult patients with wet AMD.
About Beovu® (brolucizumab)
Beovu® (brolucizumab) is a clinically advanced humanized single-chain antibody fragment (scFv)2,10. Single-chain antibody fragments are highly sought after in drug development due to their small size, tissue penetration, rapid clearance from systemic circulation and drug delivery characteristics10,11,12.
The proprietary innovate structure of brolucizumab results in a small molecule (26 kDa) with potent inhibition of, and high affinity to, all VEGF-A isoforms11. In preclinical studies, brolucizumab inhibited activation of VEGF receptors through prevention of the ligand-receptor interaction11,12,13. Increased signaling through the VEGF pathway is associated with pathological ocular angiogenesis and retinal edema8. Inhibition of the VEGF pathway has been shown to inhibit the growth of neovascular lesions and suppress endothelial cell proliferation and vascular permeability8.
About the HAWK and HARRIER studies
With more than 1,800 patients worldwide, HAWK (NCT02307682) and HARRIER (NCT02434328) are the first and only global head-to-head trials in patients with wet AMD that prospectively demonstrated efficacy at week 48 using an innovative q12w/q8w regimen, with a majority of brolucizumab patients on q12w immediately following the loading phase2. Both studies are 96-week prospective, randomised, double-masked multicentre studies and part of the Phase III clinical development of brolucizumab2. The studies were designed to compare the efficacy and safety of intravitreal injections of brolucizumab 6 mg (HAWK and HARRIER) and 3 mg (HAWK only) versus aflibercept 2 mg in patients with wet AMD2.
About wet age-related macular degeneration
Macular disease is the biggest cause of sight loss in the UK5 and age-related macular degeneration (AMD) is the most common type. There are two types of AMD, known as ‘dry’ and ‘wet’. Up to 40,000 people develop wet AMD in the UK each year1. Wet AMD occurs when abnormal blood vessels form underneath the macula, the area of the retina responsible for sharp, central vision8,14. These blood vessels are fragile and leak fluid, disrupting the normal retinal architecture and ultimately causing damage to the macula8,9.
Early symptoms of wet AMD include distorted vision (or metamorphopsia) and difficulties seeing objects clearly8,15. Prompt diagnosis and intervention are essential8,13. As the disease progresses, cell damage increases, further reducing vision quality. This progression can lead to a complete loss of central vision, leaving the patient unable to read, drive, or recognise familiar faces and potentially depriving them of their independence8,14. Without prompt treatment, vision can rapidly deteriorate16.
About Novartis in ophthalmology
At Novartis, our mission is to discover new ways to improve and extend people's lives. In ophthalmology, we develop and deliver life-changing medicines and therapies for diseases and conditions from front to back of the eye, enabled by data and transformative technologies. Our ophthalmic solutions reach more than 150M people per year, from premature infants to the elderly.
Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach more than 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 130 000 people of nearly 150 nationalities work at Novartis around the world. Find out more at www.novartis.com.
In the UK, we employ approximately 1,500 people to serve healthcare needs across the whole of the UK, as well as supporting the global operations of Novartis. Since 2014, Novartis has invested over £200 million in R&D and is a leading sponsor of clinical trials, in the UK. For more information, please visit www.novartis.co.uk.
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.
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 2021.
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.