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FDA Approves Beovu for Treatment of Wet Age-Related Macular Degeneration

A new drug for wet age-related macular degeneration (AMD) has been approved by the U.S. Food and Drug Administration (FDA). Brolucizumab (brand name Beovu®) is the first FDA-approved anti-VEGF drug to offer improved vision, greater fluid reduction, and a three-month dosing schedule after the initial ramp-up period.1

What is anti-VEGF therapy?

Anti-VEGF drugs capture VEGF, a protein that stimulates blood vessel growth. VEGF stands for vascular endothelial growth factor. When cells create VEGF in the eyes, it encourages the growth of new blood vessels, and with AMD these vessels tend to be unusually weak and leaky. This leakiness can damage the retina and results in vision loss.2 There are several anti-VEGF drugs and one of these is brolucizumab (Beovu).

What is brolucizumab (Beovu)?

Brolucizumab (Beovu®), also known as RTH258, is a treatment for wet age-related macular degeneration (AMD). It works by stopping or reducing the production of VEGF. Like other treatments for wet AMD, the drug is injected into the eye through a very small needle.1,3

Brolucizumab clinical trials

In clinical trials, people using brolucizumab (Beovu) experienced better vision and less fluid in their eyes. Doctors also measured larger decreases in retinal thickness, which leads to less fluid, as early as 16 weeks into treatment. At least 30 percent of those on the drug gained at least 15 letters after one year.1,3

During clinical trials, 90 percent of those taking the drug were age 65 or older, and 60 percent were age 75 or older. Approximately 50 percent of those participating in the drug trials maintained good results when given doses every three months. The rest were treated every two months.3

What are the possible side effects of brolucizumab?

In clinical trials, more than 1,800 people worldwide took brolucizumab (Beovu) for two years. The most common side effects were:

  • Blurred vision
  • Cataract
  • Conjunctival hemorrhage
  • Vitreous floaters
  • Eye pain1,3

Serious complications included retinal detachment, endophthalmitis (an infection inside the eye), increases in pressure inside the eye, stroke, heart attack, and sudden death.3,4

Dosing information for brolucizumab (Beovu)

The recommended dose for brolucizumab (Beovu) is 6 mg (0.05 mL of 120 mg/mL solution) injected every 25 to 31 days for the first three months. After this initial phase, the same amount of the drug is injected every 12 weeks for most patients.

It is hoped that a drug that has to be injected less often will encourage people with wet AMD to stick with their treatment regimen.

Things to know about brolucizumab

Brolucizumab (Beovu) should not be given to people who have a current infection in or near the eye, uveitis, or other eye inflammation. Call your doctor immediately if your eye becomes red, sensitive to light, painful, or your vision changes after using brolucizumab (Beovu).3

This drug has not been tested in pregnant women or women who are breastfeeding.3

  1. Novartis. Novartis receives FDA approval for Beovu®, offering wet AMD patients vision gains and greater fluid reductions vs aflibercept. Available at: https://www.novartis.com/news/media-releases/novartis-receives-fda-approval-beovu-offering-wet-amd-patients-vision-gains-and-greater-fluid-reductions-vs-aflibercept. Accessed on 10/8/19.
  2. American Macular Degeneration Foundation. Macular Degeneration Treatments. n.d. https://www.macular.org/treatments. Accessed 10/8/19.
  3. Brolucizumab (Beovu) Prescribing Information. Available at: https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/beovu.pdf. Accessed 10/8/19.
  4. American Society of Retina Specialists. Endophthalmitis. Available at: https://www.asrs.org/patients/retinal-diseases/29/endophthalmitis. Accessed 10/8/19.

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