Drug Insights

Is Brolucizumab-dbll approved by the FDA?

24 June 2024
3 min read

Yes, brolucizumab-dbll, marketed under the brand name Beovu, is FDA approved. The FDA approved Beovu on October 7, 2019, for the treatment of neovascular (wet) age-related macular degeneration (AMD). This approval marked a significant advancement in the management of AMD, providing a new option for patients suffering from this vision-impairing condition.

What is Brolucizumab-dbll?

Brolucizumab-dbll is an anti-angiogenic ophthalmic agent used primarily for treating neovascular (wet) age-related macular degeneration (AMD) and diabetic macular edema (DME). These conditions are characterized by abnormal blood vessel growth in the eye, leading to vision impairment and, potentially, blindness. Brolucizumab-dbll helps by reducing the amount of blood flow to these abnormal vessels, thus mitigating the damage to the retina.

How to Use Brolucizumab-dbll

Brolucizumab-dbll is administered as an injection into the eye by an ophthalmologist. The dosing schedule varies based on the condition being treated:

  • For Neovascular AMD: The typical regimen involves an injection every month for the first three doses, followed by injections every 8 to 12 weeks.
  • For Diabetic Macular Edema (DME): The regimen starts with an injection every six weeks for the first five doses, followed by injections every 8 to 12 weeks.

Precautions and Considerations

Before Using Brolucizumab-dbll:

  • Discuss any allergies or medical conditions with your doctor, particularly if you have a history of blood clots, detached retina, endophthalmitis, glaucoma, heart attack, stroke, or active eye infections.
  • The safety and efficacy of brolucizumab-dbll in pediatric patients have not been established.
  • For pregnant or breastfeeding women, the potential risks and benefits should be carefully weighed.

Interactions:

  • Inform your healthcare provider about any other medications you are taking, including prescription, over-the-counter drugs, vitamins, and herbal supplements.

Potential Side Effects

Common Side Effects:

  • Blurred vision
  • Eye redness
  • Decreased vision
  • Blindness
  • Bloodshot eyes

Less Common Side Effects:

  • Burning, dry, or itching eyes
  • Excessive tearing or discharge
  • Headache
  • Painful eye irritation
  • Seeing flashes of light or floating spots

Serious Side Effects:

  • Eye infections
  • Increased eye pressure
  • Retinal detachment
  • Vasculitis or vascular blockage

If you experience any severe side effects or changes in vision, contact your eye doctor immediately.

Conclusion

Brolucizumab-dbll (Beovu) was approved by the FDA on October 7, 2019, for the treatment of neovascular AMD and diabetic macular edema. Administered via injection by an ophthalmologist, it offers a new treatment option for patients with these serious eye conditions. As with any medication, it is crucial to follow your healthcare provider's instructions and attend all follow-up appointments to monitor for any adverse effects. Always discuss your full medical history and any medications you are taking with your healthcare provider to ensure the safe and effective use of brolucizumab-dbll.

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