Brolucizumab

Brolucizumab is a human VEGF inhibitor. Brolucizumab binds to the three major isoforms of VEGF-A (e.g., VEGF 110 , VEGF 121 , and VEGF 165 ), thereby preventing interaction with receptors VEGFR-1 and VEGFR-2.

• BEOVU ® is indicated for the treatment of: BEOVU is a human vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of: Neovascular (Wet) Age-Related Macular Degeneration (AMD) ( 1.1 ) Diabetic Macular Edema (DME) ( 1.2 ) 1.1 Neovascular (Wet) Age-related Macular Degeneration (AMD) 1.2 Diabetic Macular Edema (DME)ICD-10: R60.9

• Ocular or Periocular Infections ( 4.1 ) Active Intraocular Inflammation ( 4.2 ) Hypersensitivity ( 4.3 ) 4.1 Ocular or Periocular Infections BEOVU is contraindicated in patients with ocular or periocular infections. 4.2 Active Intraocular Inflammation BEOVU is contraindicated in patients with active intraocular inflammation.contraindicated

Neovascular (Wet) Age-Related Macular Degeneration (AMD) The recommended dose for BEOVU is 6 mg (0.05 mL of 120 mg/mL solution) monthly (approximately every 25-31 days) for the first three doses, followed by one dose of 6 mg (0.05 mL) every 8-12 weeks ( 2.2 ). Diabetic Macular Edema (DME) The recommended dose for BEOVU is 6 mg (0.05 mL of 120 mg/mL solution) every six weeks (approximately every 39-45 days) for the first five doses, followed by one dose of 6 mg (0.05 mL of 120 mg/mL solution) every 8-12 weeks ( 2.3 ). 2.1 General Dosing Information For ophthalmic intravitreal injection. BEOVU must be administered by a qualified physician. BEOVU is available packaged as follows [see How Supplied/Storage and Handling (16)] : Pre-filled Syringe Vial kit with injection components (vial, filter needle) 2.2 Neovascular (Wet) Age-Related Macular Degeneration (AMD) The recommended dose for BEOVU is 6 mg (0.05 mL of 120 mg/mL solution) administered by intravitreal injection monthly (approximately every 25 to 31 days) for the first three doses, followed by 6 mg (0.05 mL) by intravitreal injection once every 8 to 12 weeks. 2.3 Diabetic Macular Edema (DME) The recommended dose for BEOVU is 6 mg (0.05 mL of 120 mg/mL solution) administered by intravitreal injection every six weeks (approximately every 39-45 days) for the first five doses, followed by 6 mg (0.05 mL) by intravitreal injection once every 8-12 weeks. 2.4 Preparation for Administration – Pre-filled Syringe and Vial Store BEOVU in the refrigerator between 2°C to 8°C (36°F to 46°F); do not freeze.

Endophthalmitis and retinal detachment may occur following intravitreal injections. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay ( 5.1 ). Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported following BEOVU injections. Patients should be instructed to report any change in vision without delay ( 5.2 ). Increases in intraocular pressure (IOP) have been seen within 30 minutes of an intravitreal injection ( 5.3 ). There is a potential risk of arterial thromboembolic events (ATE) following intravitreal use of VEGF inhibitors ( 5.4 ). 5.1 Endophthalmitis and Retinal Detachment Intravitreal injections, including those with BEOVU, have been associated with endophthalmitis and retinal detachment [see Contraindications (4.1) and Adverse Reactions (6.1)] . Proper aseptic injection techniques must always be used when administering BEOVU. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately [see Dosage and Administration (2.4) and Patient Counseling Information (17)] . 5.2 Retinal Vasculitis and/or Retinal Vascular Occlusion Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported with the use of BEOVU. These immune-mediated adverse events may occur following the first intravitreal injection. Discontinue treatment with BEOVU in patients who develop these events.

The following potentially serious adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Contraindications (4.3)] Endophthalmitis and Retinal Detachment [see Warnings and Precautions (5.1)] Retinal Vasculitis and/or Retinal Vascular Occlusion [see Warnings and Precautions (5.2)] Increase in Intraocular Pressure [see Warnings and Precautions (5.3)] Thromboembolic Events [see Warnings and Precautions (5.4)] The most common adverse reactions reported in patients receiving BEOVU are vision blurred, cataract, conjunctival hemorrhage, eye pain, and vitreous floaters ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in one clinical trial of a drug cannot be directly compared with rates in the clinical trials of the same or another drug and may not reflect the rates observed in practice. A total of 1,646 patients treated with brolucizumab constituted the safety population in four Phase 3 studies. Among these, 1,098 patients were treated with the recommended dose of 6 mg. A total of 1,088 patients treated with brolucizumab, constituted the safety population in the two controlled neovascular AMD Phase 3 studies (HAWK and HARRIER) with a cumulative 96-week exposure to BEOVU, and 730 patients treated with the recommended dose of 6 mg [see Clinical Studies (14.1)] .

8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies of BEOVU administration in pregnant women. In an animal reproduction study, intravitreal administration of brolucizumab to pregnant monkeys once every 4 weeks in one eye from organogenesis to birth did not indicate any harmful effects with respect to pre- or postnatal development at 10-fold the maximum recommended human dose (MRHD) on a mg/kg basis ( see Data ). Based on the anti-VEGF mechanism of action for brolucizumab [see Clinical Pharmacology (12.1)] , treatment with BEOVU may pose a risk to human embryo-fetal development. BEOVU should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. All pregnancies have a background risk of birth defect, loss, and other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. Data Animal Data In an enhanced pre- and postnatal development (ePPND) study in pregnant cynomolgus monkeys, brolucizumab was administered to all animals by intravitreal (IVT) injection to one eye at doses of 3 or 6 mg once every 4 weeks until delivery.

Metabolism

Following a single intravitreal dose of BEOVU to 25 AMD patients, the mean (range) serum C max of free brolucizumab (unbound to VEGF-A) was 49 ng/mL (9 to 548 ng/mL) and was attained at 24 hours post-dose. Brolucizumab concentrations were near or less than 0.5 ng/mL (lower limit of assay quantitation) at approximately 4 weeks after repeat dose administration and no accumulation in serum was observed in most patients.

• Oct 7, 2019BLABLA761125Novartis Pharms Corp

1. 1Visual Impairment56716%
2. 2Vitreous Floaters55616%
3. 3Vision Blurred52715%
4. 4Eye Inflammation44712%
5. 5Visual Acuity Reduced42512%
6. 6Retinal Vasculitis38111%
7. 7Uveitis36110%
8. 8Vitritis3549.9%
9. 9Eye Pain3188.9%
10. 10Blindness2446.8%
11. 11Anterior Chamber Cell2286.4%
12. 12Ocular Hyperaemia2236.2%
13. 13Vitreous Opacities2216.2%
14. 14Drug Ineffective2176.1%
15. 15Keratic Precipitates2125.9%

The 10 most recently updated of 59 ClinicalTrials.gov registrations naming Brolucizumab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Post Marketing Study to Evaluate the Safety and Effectiveness of Brolucizumab in Patients With Diabetic Macular Edema.
  Completed · Phase 4 · Interventional · 66 enrolled · Novartis Pharmaceuticals
  NCT05959304updated 2026-04-13
• the Blood-Aqeous Barrier During Anti-Angiogenic Therapy in Exudative Age-Related Macular Degeneration
  Completed · Interventional · 30 enrolled · The Filatov Institute of Eye Diseases and Tissue Therapy
  NCT07375901updated 2026-01-29
• Study Assessing the Efficacy and Safety of a Personalized Monotherapy Regimen of Brolucizumab in Patients With Symptomatic Macular Polypoidal Choroidal Vasculopathy
  Completed · Phase 3 · Interventional · 148 enrolled · Novartis Pharmaceuticals
  NCT05666804updated 2025-12-15
• Comparison of Rapid Aflibercept and Brolucizumab T&E in wAMD
  Active not recruiting · Interventional · 80 enrolled · Berner Augenklinik
  NCT04932980updated 2025-12-08
• Observational Study to Evaluate Fluid Resolution and Effectiveness in Patients Receiving Beovu in Neovascular Age-related Macular Degeneration and Visual Impairment Due to Diabetic Macular Edema
  Completed · Observational · 572 enrolled · Novartis Pharmaceuticals
  NCT04543331updated 2025-12-01
• Study of Efficacy and Safety of Brolucizumab Versus Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy
  Completed · Phase 3 · Interventional · 689 enrolled · Novartis Pharmaceuticals
  NCT04278417updated 2025-10-16
• Efficacy and Safety of Two Different Brolucizumab 6 mg Dosing Regimens in Neovascular Age-related Macular Degeneration
  Completed · Phase 4 · Interventional · 52 enrolled · Novartis Pharmaceuticals
  NCT04679935updated 2025-09-26
• Anti-vascular Endothelial Growth Factor (Anti-VEGF) Monotherapy vs Anti-VEGF Followed by Subthreshold Micropulse Laser for Treating Severe Diabetic Macular Oedema When the Central Retina Goes <400 Microns
  Recruiting · Phase 3 · Interventional · 264 enrolled · Belfast Health and Social Care Trust
  NCT06985706updated 2025-09-19
• Brolucizumab Versus Aflibercept on Visual and Anatomical Outcomes in Diabetic Macular Edema
  Completed · Interventional · 38 enrolled · Benha University
  NCT07096713updated 2025-07-31
• Special Drug Use Observational Study With Beovu Kit for Intravitreal Injection
  Completed · Observational · 222 enrolled · Novartis Pharmaceuticals
  NCT05526729updated 2025-06-13

Frequently asked questions

How does Brolucizumab work?

Brolucizumab is a human VEGF inhibitor. Brolucizumab binds to the three major isoforms of VEGF-A (e.g., VEGF 110 , VEGF 121 , and VEGF 165 ), thereby preventing interaction with receptors VEGFR-1 and VEGFR-2.

What is Brolucizumab used for?

According to FDA labeling, Brolucizumab carries indications including: BEOVU ® is indicated for the treatment of: BEOVU is a human vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of: Neovascular (Wet) Age-Related Macular Degeneration (AMD) ( 1.1 ) Diabetic Macular Edema (DME) ( 1.2 ) 1.1 Neovascular (Wet) Age-related Macular Degeneration (AMD) 1.2 Diabetic Macular Edema (DME). This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Brolucizumab?

Brolucizumab is classified as Antineovascularisation agents, Vascular Endothelial Growth Factor Inhibitors, Decreased Endothelial Proliferation, Vascular Growth Decrease.

What are the brand names for Brolucizumab?

Brolucizumab is marketed under brand names including Beovu.

What are the contraindications for Brolucizumab?

Brolucizumab labeling lists contraindications including: Ocular or Periocular Infections ( 4.1 ) Active Intraocular Inflammation ( 4.2 ) Hypersensitivity ( 4.3 ) 4.1 Ocular or Periocular Infections BEOVU is contraindicated in patients with ocular or periocular infections. 4.2 Active Intraocular Inflammation BEOVU is contraindicated in patients with active intraocular inflammation.. Always consult the full prescribing information and a clinician.