Novartis announced today that the US Food and Drug Administration (FDA) approved BEOVU® (brolucizumab-dbll) injection for the treatment of wet age-related macular degeneration (wet AMD). Wet AMD is caused by too much VEGF (vascular endothelial growth factor), a protein which at high levels can lead to the growth of abnormal blood vessels that can leak fluid into the retina.1 BEOVU is specifically designed to block VEGF.2,3 This important milestone provides more options for patients.
As we well know, wet AMD has a dramatic impact on patients and their caregivers.4 When someone’s vision is severely impaired, it can take away the independence and freedom that they once enjoyed.4 Medical treatments such as BEOVU may help patients living with wet AMD maintain their vision.
For more information, please visit https://www.pharma.us.novartis.com/news/media-releases/novartis-receives-fda-approval-beovu-offering-wet-amd-patients-vision-gains-and.
BEOVU® (brolucizumab-dbll) injection is used for the treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD).
Important Safety Information
You should not use BEOVU if you have an infection in or around the eye, eye inflammation, or if you are allergic to brolucizumab or any of the ingredients in BEOVU.
BEOVU is a prescription medicine given by injection into the eye. Injections in the eye, including BEOVU, may cause an infection of the eye or retinal detachment (separation of retina from the back of the eye). It is important to contact your doctor right away if your eye becomes red, sensitive to light, painful, or you develop a change in your vision.
Increased eye pressure has been seen within 30 minutes of an eye injection, including BEOVU. Sustained increases in eye pressure also have been reported. Your doctor should monitor for this when you receive a BEOVU injection.
There is a potential risk of stroke, heart attack, or blood clots in patients receiving eye injections of vascular endothelial growth factor (VEGF) inhibitor drugs, including BEOVU.
The most common side effects reported in patients receiving BEOVU were reduced clarity in vision, cataract, broken blood vessels in the eye, and vitreous floaters (moving spots in the field of vision).
You are encouraged to report negative side effects to FDA at www.fda.gov/medwatch or (800) FDA-1088.
Please see full Prescribing Information.
- 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.
- Dugel P, at al. HAWK and HARRIER: Phase 3, multicenter, randomized, double-masked trials of brolucizumab for neovascular age-related macular degeneration [published online ahead of print April 12, 2019]. Ophthalmology. doi:10.1016/j.ophtha.2019.04.017.
- BEOVU [prescribing information] East Hanover, NJ. Novartis: 2019.
- Mitchell J, Bradley C. Quality of life in age-related macular degeneration: a review of the literature. Health Qual Life Outcomes. 2006;4:97.