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Drug

Brolucizumab

Approved · EMA
Emerging researchLate-stage development

Also known as Beovu.

RxNorm2204915UNIIXSZ53G39H5
2
Research papers
1
Active clinical trials
2
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Study Comparing Early Extension of Aflibercept and Brolucizumab in Wet AMD (SPARROW)

Clinical trial2025-12-08Results expected Q2 2027 · ClinicalTrials.gov

A Prospective, Multi-center, Open-label, Phase IV Study to Evaluate the Safety and Effectiveness of Intravitreal Injections (IVI) of Brolucizumab in Patients With Diabetic Macular Edema (DME).

Clinical trial2025-11-17Completed · ClinicalTrials.gov

A 96-week, Two-arm, Randomized, Single-masked, Multi-center, Phase III Study Assessing the Efficacy and Safety of Brolucizumab 6 mg Compared to Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy

Clinical trial2025-10-16Results posted · ClinicalTrials.gov

A 52-week, Two Arm, Randomized, Open-label, Multicenter Study Assessing the Efficacy and Safety of Two Different Brolucizumab 6 mg Dosing Regimens for Patients With Suboptimal Anatomically Controlled Neovascular Age-related Macular Degeneration

Clinical trial2025-09-26Results posted · ClinicalTrials.gov

A 60-week, Phase IIIb, Randomized, Multi-center Study Assessing the Efficacy and Safety of a Personalized Monotherapy Regimen of Brolucizumab in Patients With Symptomatic Macular Polypoidal Choroidal Vasculopathy (PROUD Study)

Clinical trial2025-09-10Completed · ClinicalTrials.gov

Brolucizumab Switch and Extend Ph IIIb Study: A Canadian, Multi-center, Single-arm, Open Label Study Assessing the Efficacy and Safety of Brolucizumab 6mg in a Treat and Extend Regimen in Patients With Neovascular Age-Related Macular Degeneration (nAMD) With Prior Anti-VEGF Exposure (PEREGRINE)

Clinical trial2025-05-31Withdrawn · ClinicalTrials.gov

One Year, Single Arm, Open Label, Multicenter, Phase IV Study Using Multimodal Imaging to Guide Disease Activity Assessment Through Innovative Early Predictive Anatomical Biomarkers of Fluid Resolution in wAMD Patients Treated With Brolucizumab- IMAGINE Study

Clinical trial2025-05-16Results posted · ClinicalTrials.gov

A Real-world, Prospective, Multi-center, Open-label, Phase IV Clinical Study to Evaluate the Safety and Effectiveness of Intravitreal Injections (IVI) of Brolucizumab in Patients With Neovascular Age-related Macular Degeneration (nAMD)

Clinical trial2025-03-20Results posted · ClinicalTrials.gov

Drug Safety Update: Brolucizumab (Beovu▼): risk of intraocular inflammation and retinal vascular occlusion increased with short dosing intervals

Regulatory2022-01-18MHRA

Approval: Beovu (EMA)

Regulatory2020-02-13EMA

Brolucizumab: Evolution through Preclinical and Clinical Studies and the Implications for the Management of Neovascular Age-Related Macular Degeneration.

Research2020-01-17Ophthalmology

HAWK and HARRIER: Phase 3, Multicenter, Randomized, Double-Masked Trials of Brolucizumab for Neovascular Age-Related Macular Degeneration.

Research2019-04-12Ophthalmology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Brolucizumab
Aliases & brands
Beovu
RxNorm CUI
2204915
UNII
XSZ53G39H5
Regulatory jurisdictions
emamhra

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2020-02-13
Latest approval
2020-02-13
Authorities
EMA · MHRA
Total events
2
emaEuropean Medicines Agency· 1 event
2020-02-13Approval
Approval: Beovu (EMA)

Indication: Beovu is indicated in adults for the treatment of neovascular (wet) age-related macular degeneration (AMD).

Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 1 event
2022-01-18Safety communicationSafety
Drug Safety Update: Brolucizumab (Beovu▼): risk of intraocular inflammation and retinal vascular occlusion increased with short dosing intervals
Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

22 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
22
registered trials across all phases
LATEST COMPLETION 2025
1
Active studies
22
Late-stage (III+)
15
Completed
6
Discontinued
PHASE DISTRIBUTIONn = 22
Phase 316Phase 45Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Prospective, Multi-center, Open-label, Phase IV Study to Evaluate the Safety and Effectiveness of Intravitreal Injections (IVI) of Brolucizumab in Patients With Diabetic Macular Edema (DME).

CompletedPH IVNovartis Pharmaceuticalsn=662025

A 52-week, Two Arm, Randomized, Open-label, Multicenter Study Assessing the Efficacy and Safety of Two Different Brolucizumab 6 mg Dosing Regimens for Patients With Suboptimal Anatomically Controlled Neovascular Age-related Macular Degeneration

CompletedPH IVNovartis Pharmaceuticalsn=522024

One Year, Single Arm, Open Label, Multicenter, Phase IV Study Using Multimodal Imaging to Guide Disease Activity Assessment Through Innovative Early Predictive Anatomical Biomarkers of Fluid Resolution in wAMD Patients Treated With Brolucizumab- IMAGINE Study

CompletedPH IVNovartis Pharmaceuticalsn=1222023

Treatment of Recalcitrant Neovascular AMD Using Brolocizumab With a Novel Treat and Extend Protocol - a Randomized Controlled Prospective Study

CompletedPH IVThe University of Hong Kongn=302023

A Real-world, Prospective, Multi-center, Open-label, Phase IV Clinical Study to Evaluate the Safety and Effectiveness of Intravitreal Injections (IVI) of Brolucizumab in Patients With Neovascular Age-related Macular Degeneration (nAMD)

CompletedPH IVNovartis Pharmaceuticalsn=1052023

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Prospective, Multi-center, Open-label, Phase IV Study to Evaluate the Safety and Effectiveness of Intravitreal Injections (IVI) of Brolucizumab in Patients With Diabetic Macular Edema (DME).

CompletedPH IVNovartis Pharmaceuticalsn=662025

A 60-week, Phase IIIb, Randomized, Multi-center Study Assessing the Efficacy and Safety of a Personalized Monotherapy Regimen of Brolucizumab in Patients With Symptomatic Macular Polypoidal Choroidal Vasculopathy (PROUD Study)

CompletedPH IIINovartis Pharmaceuticalsn=1482025

A 96-week, Two-arm, Randomized, Single-masked, Multi-center, Phase III Study Assessing the Efficacy and Safety of Brolucizumab 6 mg Compared to Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy

CompletedPH IIINovartis Pharmaceuticalsn=6892024

A Twelve-Month, Randomized, Double-Masked, Multicenter, Phase III, Two-Arm Study Comparing the Efficacy and Safety of Brolucizumab 6 mg Versus Aflibercept in Chinese Patients With Neovascular Age-Related Macular Degeneration

CompletedPH IIINovartis Pharmaceuticalsn=3972024

A 52-week, Two Arm, Randomized, Open-label, Multicenter Study Assessing the Efficacy and Safety of Two Different Brolucizumab 6 mg Dosing Regimens for Patients With Suboptimal Anatomically Controlled Neovascular Age-related Macular Degeneration

CompletedPH IVNovartis Pharmaceuticalsn=522024

One Year, Single Arm, Open Label, Multicenter, Phase IV Study Using Multimodal Imaging to Guide Disease Activity Assessment Through Innovative Early Predictive Anatomical Biomarkers of Fluid Resolution in wAMD Patients Treated With Brolucizumab- IMAGINE Study

CompletedPH IVNovartis Pharmaceuticalsn=1222023

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Major research themes2
Disease Management1Visual Acuity1
Journals, researchers & institutions
Top journals
  • Ophthalmology2
Leading researchers
  • Dugel PU2
  • Holz FG2
  • Koh A2
  • Brown DM1
  • Das A1
  • Do DV1
  • Gomes A1
  • Gomes AV1
Leading institutions
free-text, unnormalised
  • University of Bonn2
  • University of Sao Paulo2
  • Arizona; University of Southern California1
  • Byers Eye Institute1
  • Camden Medical Centre1
  • Duke Eye Center1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.