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Beovu FDA Approval History

Reviewed by J.Stewart BPharm. Last updated on Oct 9, 2019.

FDA Approved: Yes (First approved October 7, 2019)
Brand name: Beovu
Generic name: brolucizumab-dbll
Dosage form: Injection
Company: Novartis Pharmaceuticals Corporation
Treatment for: Macular Degeneration

Beovu (brolucizumab-dbll) is a human vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD).

  • By inhibiting VEGF, Beovu works to suppress the growth of abnormal blood vessels under the macula and reduce the potential for vision loss caused by fluid leakage into the retina.
  • Beovu is administered by intravitreal injection into the vitreous cavity of the eye every month for the first three doses, then every 8-12 weeks.
  • Common side effects include: vision blurred, cataract, conjunctival hemorrhage, vitreous floaters, and eye pain.

Development Timeline for Beovu

Oct  8, 2019Approval FDA Approves Beovu (brolucizumab-dbll) for the Treatment of Wet Age-Related Macular Degeneration (AMD)
Apr 15, 2019Novartis Announces FDA Filing Acceptance and Priority Review of Brolucizumab (RTH258) for Patients with Wet AMD
Oct 27, 2018Two-year data for Novartis brolucizumab reaffirm superiority versus aflibercept in reducing retinal fluid in patients with nAMD
Sep 22, 2018New analysis of Novartis Phase III brolucizumab (RTH258) data reinforces superior reduction of retinal fluid, a key marker of disease activity in nAMD
Apr 30, 2018New Novartis Phase III data for Brolucizumab Demonstrate Reliability of 12-week Treatment Interval

Further information

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