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Beovu

Beovu is the market name for the drug, brolucizumab, and is typically prescribed to treat “wet” age-related macular degeneration (AMD) in patients. Wet AMD is a condition wherein new blood vessels develop in the eye which can cause loss of vision.  

The active chemical matrix in Beovu works to inhibit the presence of another compound referred to as vascular endothelial growth factor (VEGF). If excess levels of VEGF are present in the human eye, blood vessel production results and consequently the potential for wet AMD. According to Beovu’s manufacturer, global pharmaceutical firm Novartis, Beovu was designed to block VEGF and alleviate vision loss resulting from wet AMD.

Beovu is injected directly into the gelatinous vitreal cavity of the human eye and is typically injected monthly for the first 2-3 doses and then once every 8-12 weeks thereafter. Beovu is only available by prescription and must be administered by a qualified professional.

Novartis launched Beovu following its approval by the U.S. Food and Drug Administration (FDA) in October 2019.  Less than one year following approval, some patients reported issues with intraocular inflammation; retinal vasculitis; and vascular occlusion; conditions that can lead to vision loss. In February 2020, the American Society of Retina Specialists (ASRS) issued a safety update for doctors concerning Beovu.

The FDA has not taken any formal action with respect to Beovu. However, Novartis submitted a new label update to the FDA in June 2020 which includes additional safety information concerning retinal vasculitis and vascular occlusion.

Prescription Name and Overview

Beovu is the brand name for a prescription medication designed to treat “wet” AMD, a chronic eye condition caused by abnormal blood vessel formations. The condition can cause blurred vision or blind spots in the visual field of sufferers. Symptoms of wet AMD tend to appear rapidly and worsen. Typical symptoms include:

  • Visual Distortion
  • Impaired Central Vision
  • Blurry Spots in Field of Vision
  • Facial Recognition Issues
  • Increased Lighting Needs
  • Decreased Color Brightness
  • Difficulty Reading Due to Blurriness

Beovu was approved by the FDA in October 2019 for the treatment of AMD. It is classified as a VEGF inhibitor due to its ability to inhibit the growth of the blood vessels which leads to AMD.

Generic Name and Overview

Brolucizumab (marketed as Beovu).

OTC  Name and Overview

Manufacturer

Beovu (brolucizumab)

Novartis International AG (Basel, Switzerland)

Novartis-U.S. (Cambridge, Massachusetts)

Drug Development

ESBATech (phase IIa)

Alcon Laboratories (phase IIb)

Labeled Indications

Beovu is a human vascular endothelial growth factor inhibitor and is used in the treatment of wet, age-related macular degeneration.

Dosages

Beovu is administered by intravitreal injection. Intravitreal injections involve the insertion of a syringe needle directly into the gelatinous pocket at the back of the eye. This procedure is usually performed by a trained specialist.  The recommended dose is 6mg every 25-31 days for the first three doses. Afterward, patients may receive 6mg doses every 8-12 weeks.

What Is It Used For?

The active compound matrix in Beovu is classified as a VEGF inhibitor, meaning it blocks a critical protein key to the creation of certain blood vessels in the eye. These blood vessels can grow, then leak blood and other fluids into the eye causing damage and vision loss.

What are the Approved Uses?

Beovu was approved by the FDA in October 2019 to treat wet age-related macular degeneration.

Production Anecdotes / History

Beovu began development from its inception as a targeted drug meant to address a specific protein sequence that causes blood vessels in the eye to grow abnormally and impair vision. It was approved by the FDA following two masked clinical trials code-named HAWK and HARRIER which included among them more than 1,800 enrolled patients around the world. A major perceived benefit of Beovu over earlier AMD therapies (such as Eylea) is that it allows a higher concentration of its key compound to reach the retina and choroid following injection.

In February 2020, the American Society of Retina Specialists issued a safety update concerning Beovu which enumerated 14 cases of patients developing retinal vasculitis following injection. At least 11 of the detailed cases involved retinal vasculitis of a nature that can cause vision loss. The FDA has not issued any warning or communication concerning Beovu. However, Beovu’s manufacturer, Swiss-based Novartis, added a new warning on its label in June 2020 to included additional safety information concerning retinal vasculitis and retinal vascular occlusion.

Precautions

Retinal Vasculitis and/or Retinal Vascular Occlusion

Patients have reported symptoms of retinal vasculitis and retinal vascular occlusion following injections with Beovu.  Retinal vasculitis is an inflammation of the branches of the retinal artery and retinal occlusion is a blockage of the small veins that carry blood away from the retina. These conditions can lead to permanent vision loss. Patients on Beovu experiencing any vision loss should tell their physician or medical professional immediately.

Endophthalmitis/Retinal Detachment

Endophthalmitis and/or retinal detachment may occur following injections into the eye. Beovu patients experiencing symptoms should tell their physician or medical professional immediately.

Intraocular Pressure and Thromboembolic Events

An increase of pressure within the eye and increased risk of arterial thromboembolic events (ATE) following injection with VEGF inhibitors have been noticed.

Long-Term Use Considerations

Aside from the larger vision issues identified on Beovu’s warning label, the most common adverse reactions experienced by Beovu patients are:

  • Blurred Vision
  • Cataracts
  • Conjunctival Hemorrhage
  • Eye Pain
  • Vitreous Floaters
  • Intraocular Inflammation
  • Retinal Hemorrhage
  • Vitreous Detachment
  • Conjunctivitis
  • Retinal Pigment Epithelial Tear
  • Corneal Abrasion
  • Hypersensitivity
  • The detachment of Retinal Pigment Epithelium
  • Punctate Keratitis
  • Retinal Tear
  • Endophthalmitis
  • Blindness
  • Conjunctival Hyperemia
  • Lacrimation Increased
  • Abnormal Eye Sensation

Drug Interactions

Advise your physician or attending professional of any medications you use, including over-the-counter medication and vitamins; prior to injections of Beovu.  

Long-Term Side Effects

Long term side effects from use of Beovu are not well documented.

FDA Warnings (History Of)

The FDA has not issued any warning or other drug communication for Beovu as of the date of this article. However, less than six months following Beovu’s release in October 2019, the American Society of Retina Specialists released a communication to its members in February 2020 highlighting already developing cases of occlusive retinal vasculitis in patients – a condition which could lead to permanent vision loss.  

Beovu’s manufacturer, Novartis AG, moved swiftly to amend the warnings on Beovu’s label and submitted a new label to the FDA in June 2020. The new warnings include safety information concerning retinal vasculitis and retinal vascular occlusion.

Lawsuits

Attorneys are currently conducting research into potential claims for vision loss resulting from Beovu. Lawsuits are anticipated and patients who took Beovu and suffered either partial or total vision loss should consider discussing their options with an attorney at the earliest opportunity.

Sources Cited (12)

1. “Label: BEOVU- brolucizumab injection, solution” https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5d1dc1fa-a2d3-46ed-9e9a-c1a036590d3d

2. “Brolucizumab (Beovu) for age-related macular degeneration” https://pubmed.ncbi.nlm.nih.gov/32022789/

3. “Novartis Knew About Beovu Vision Risks but Failed to Warn, Plaintiff Says” https://newyork.legalexaminer.com/health/novartis-knew-about-beovu-vision-risks-but-failed-to-warn-plaintiff-says/

4. “Clinical Review Report: Brolucizumab (Beovu)” https://www.ncbi.nlm.nih.gov/books/NBK565330/

5. “Clinical Review Report: Brolucizumab (Beovu): (Novartis Pharmaceuticals Canada Inc.): Indication: Treatment of Neovascular (wet) Age-Related Macular Degeneration (AMD) [Internet].” https://www.ncbi.nlm.nih.gov/books/NBK565337/

6. “Pharmacoeconomic Report: Brolucizumab (Beovu): (Novartis Pharmaceuticals Canada Inc.): Indication: Treatment of neovascular (wet) age-related macular degeneration (AMD) [Internet].” https://www.ncbi.nlm.nih.gov/books/NBK565511/

7. “Drug Approval Package: BEOVU (brolucizumab-dbll)” https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761125_Orig1_toc.cfm

8. “US FDA approves updated Novartis Beovu® label, to include additional safety information” https://www.novartis.com/news/media-releases/us-fda-approves-updated-novartis-beovu-label-include-additional-safety-information

9. “’Lightning struck’: How a safety alert shifted doctor sentiment on Novartis’ Beovu” https://www.fiercepharma.com/pharma/lightning-struck-how-a-safety-alert-shifted-doctor-sentiment-novartis-beovu?amp%3Butm_medium=rss%20

10. “Novartis identifies possible risk factors for Beovu patients” https://www.reuters.com/article/novartis-beovu-safety-idUSL8N2I004K

11. “Eye drug side effects are real, Novartis confirms in new warning” https://www.biopharmadive.com/news/novartis-beovu-safety-fda-eylea-regeneron/575816/

12. “Beovu Prescribing Information” https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761125s004lbl.pdf

Tracy Everhart is the Editor for Drug Law Journal. A highly-trained and certified medical professional, Tracy is also an accomplished medical writer. After spending years on the front lines of the medical profession, Tracy now devotes her expertise and skills to researching and reporting on new drugs and devices that enter the market, as well as their side-effects and the real-life stories involved. Prior to joining Drug Law Journal, Tracy wrote for benchmark online healthcare resources focused on families and, in particular, women’s health issues. Tracy holds post-graduate degrees from both the American College of Healthcare Sciences and the Yale School of Nursing. She is also a graduate of both Hampshire College, where she studied microbiology and the University of South Carolina school of nursing.

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