Novartis Receives FDA Approval for Beovu for Wet AMD

Source: Novartis

Novartis announced that the FDA approved Beovu (brolucizumab-dbll) injection, also known as RTH258, for the treatment of wet age-related macular degeneration (AMD). Beovu is the first FDA approved anti-VEGF to offer both greater fluid resolution versus aflibercept and the ability to maintain eligible wet AMD patients on a 3-month dosing interval immediately after a 3-month loading phase,1 according to a company news release.

“Beovu is the first FDA approved anti-VEGF that really offers three things all in one product. One, it’s the vision gains that doctors expect from anti-VEGFs. Beyond that, specifically for doctors, they see greater fluid resolution and fluid reduction in the layers of the retina. And for patients, longer dosing intervals are really important for them,” Patrick Mooney, vice president and head, Eyecare Franchise, at Novartis, said in an interview with Eyewire News. “Patients want to be treated less frequently so this is the first time you’ve seen, combined in one product, the vision gains that we expect, the reductions in fluid that doctors expect, as well as the ability, after three monthly loading doses, to go right to 12 weeks if able, and deliver upon that without any compromise in efficacy.”

“Beovu meets our goals in clinical practice for treating wet AMD: improving vision and drying retinal fluid,” Pravin U. Dugel, MD, Managing Partner, Retinal Consultants of Arizona; Clinical Professor, Roski Eye Institute, Keck School of Medicine, University of Southern California; and principal investigator of the HAWK clinical trial, said in a company news release. “With Beovu, greater fluid reduction was demonstrated through larger decreases in retinal thickness and a higher proportion of patients with drier retinas. Coupled with the potential to treat patients with quarterly injections, this approval may change the way we approach the treatment of wet AMD.”

The approval of Beovu was based on findings from the phase 3 HAWK and HARRIER clinical trials, in which Beovu demonstrated noninferiority versus aflibercept in mean change in best-corrected visual acuity (BCVA) at year 1 (week 48).1,2 In both clinical trials, approximately 30% of patients gained at least 15 letters at year one. In HAWK and HARRIER, Beovu showed greater reduction in central subfield thickness (CST) as early as week 16 and at year 1, and fewer patients had intraretinal (IRF) and/or subretinal fluid (SRF).2

The Beovu molecule is engineered to deliver the highest concentration of drug, providing more active binding agents than other anti-VEGFs, according to Novartis. By inhibiting VEGF, Beovu suppresses the growth of abnormal blood vessels and the potential for fluid leakage into the retina.2

“The approval of Beovu delivers on the Novartis commitment to reimagining treatments for patients suffering from serious visual impairment,” Marie-France Tschudin, President, Novartis Pharmaceuticals, said in the news release. “The product labels of existing treatments state that they are not as effective when dosed every 12 weeks. Beovu is the first to offer less frequent dosing in the first year of therapy while maintaining its effectiveness. This gives more time for wet AMD patients to focus on what’s important in their lives.”

In HAWK and HARRIER, eligible patients could be maintained on a 3-month dosing interval immediately after the loading phase.1,2 At year 1, over half of patients were maintained on the 3-month dosing interval (56% in HAWK and 51% in HARRIER). The remaining patients in the study were treated on a 2-month dosing schedule.1,2

Beovu exhibited an overall safety profile comparable to aflibercept. Beovu is contraindicated in patients with ocular or periocular infections, active intraocular inflammation or with known hypersensitivity to brolucizumab or any of the excipients in Beovu. Hypersensitivity reactions may manifest as rash, pruritus, urticaria, erythema or severe intraocular inflammation.1

The most common adverse events (≥5% of patients) with Beovu were vision blurred, cataract, conjunctival hemorrhage, vitreous floaters and eye pain.1,2

“As sight disappears, so does a person’s connection to the world,” Dawn Prall, Founder and Executive Director, The Support Sight Foundation, said in the news release. “We welcome a new treatment that helps maintain vision and has the potential for quarterly treatments, which can reduce the burden on patients and their caregivers and help people with wet AMD keep doing what they love with the people they love.”

With this approval, Novartis is offering “Beovu Your Way” in the United States. This program provides personalized, one-on-one support for patients and caregivers, with access to a care specialist committed to understanding patients’ unique needs and preferences. Novartis is partnering with patient advocacy organizations to deliver educational materials for patients and caregivers, with the goal of empowering wet AMD patients to live safely and independently.


1. BEOVU [prescribing information] East Hanover, NJ. Novartis: 2019.

2. Dugel P, et al. HAWK and HARRIER: Phase 3, multicenter, randomized, double-masked trials of brolucizumab for neovascular age-related macular degeneration [published online ahead of print]. Ophthalmology. 2019.

3. 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.

4. 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.

5. Singer M. Advances in the management of macular degeneration. F1000Prime Rep. 2014;6:29.

6. 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.

7. Qazi Y, et al. Mediators of ocular angiogenesis. J. Genet. 2009;88(4):495-515.

8. National Eye Institute. Facts About Age-Related Macular Degeneration. Available athttps://nei.nih.gov/health/maculardegen/armd_facts (link is external). Accessed September 2019.

9. World Health Organization. Priority eye diseases: Age-related macular degeneration. Available athttp://www.who.int/blindness/causes/priority/en/index7.html (link is external). Accessed September 2019.

10. NHS Choices. Macular Degeneration. Available at http://www.nhs.uk/Conditions/Macular-degeneration/Pages/Introduction.aspx (link is external). Accessed September 2019.

11. 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.

12. Mitchell J, Bradley C. Quality of life in age-related macular degeneration: a review of the literature. Health Qual Life Outcomes. 2006;4:97.

13. Friedman DS, O’Colmain BJ, Munoz B, et al. Prevalence of age-related macular degeneration in the United States. Arch Ophthalmol. 2004;122(4):564-72.

14. Klein R, Chou CF, Klein BE, Zhang X, Meuer SM, Saaddine JB. Prevalence of age-related macular degeneration in the U.S. population. Arch Ophthalmol. 2011;129(1):75-80.

15. American Academy of Ophthalmology. Age-related macular degeneration preferred practice patterns. Available at: https://www.aao.org/preferred-practice-pattern/age-related-macular-degeneration-ppp-2015 (link is external). Accessed September 2019.

16. 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.

17. Escher D, et al. Single-chain antibody fragments in ophthalmology. Oral presentation at EURETINA congress. 2015. Abstract.

18. 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 September 2019.

19. 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.

20. 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.

21. Healthline. What is metamorphopsia? Available at https://www.healthline.com/health/metamorphopsia(link is external). Accessed September 2019.

22. 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.

Related Content