Beovu

(Brolucizumab)

ApprovedMonoclonal antibody

Beovu is a monoclonal antibody that works as a VEGF-a Inhibitor.[2] It is being used across 5 indications, with its most advanced program in Approved.[1]

Beovu is one of 45 antibody fragment programs targeting Wet Age-Related Macular Degeneration. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Macular DegenerationUnknown

Ocular Vascular DiseaseUnknown

Wet Macular DegenerationUnknown

Diabetic Macular EdemaActive, not recruiting

Unknown

Macular DegenerationPreclinical

Unknown

Ocular Vascular DiseasePreclinical

Unknown

Wet Macular DegenerationPreclinical

Unknown

Diabetic Macular EdemaApproved

Active, not recruiting

Competition

Competitive Landscape

36 competitors in Diabetic Macular Edema

#DrugCompanyPhaseTrials

Eylea

Regeneron

Approved

53 2

Vabysmo

Roche

Approved

12 3

Decadron

AAspen Global Incorporated

Approved

13 4

Amaryl

Sanofi

Approved

1 5

Aldactone

Pfizer

Approved

1 6

Beovu

Novartis

Approved

6 7

Kenalog

BBassett Healthcare

Approved

4 8

Klor-Con

Jardiance

1 10

Farxiga

AstraZeneca

Phase 2

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2028

N/AActive, not recruiting

Wamd

NCT04932980

Clinical

Trials by Indication[1]

Age-Related Macular Degeneration9 trials

Study of Efficacy and Safety of Brolucizumab vs. Aflibercept in Chinese Patients With Neovascular Age-Related Macular Degeneration

Completed· Novartis logo

Novartis·Phase 3·NCT04047472·397 enrolled

Study to Evaluate the Safety and Effectiveness of Intravitreal Injections (IVI) of Brolucizumab in Patients With Neovascular Age-related Macular Degeneration (nAMD)

Completed· Novartis logo

Novartis·Phase 4·NCT05269966·105 enrolled

Efficacy and Safety of Two Different Brolucizumab 6 mg Dosing Regimens in Neovascular Age-related Macular Degeneration

Completed· Novartis logo

Novartis·Phase 4·NCT04679935·52 enrolled

Show 6 more trials

Real-world Evaluation of Brolucizumab for the Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD) (Komodo Health)

Completed· Novartis logo

Novartis··NCT05111743·9,261 enrolled

Safety and Pharmacokinetics of RTH258 in Subjects With Age-Related Macular Degeneration

Completed·AAlcon Research·Phase 2·NCT02507388·51 enrolled

Intravitreal Brolucizumab in Neovascular Age-related Macular Degeneration With Limited Response to Aflibercept

Terminated·VVista Klinik·Phase 4·NCT04287348·16 enrolled

Real-world Evaluation of Brolucizumab for the Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD) (IRIS Study)

Completed· Novartis logo

Novartis··NCT05082415·9,456 enrolled

An Extension Study Assessing the Efficacy and Safety of Brolucizumab in a Treat-to-Control Regimen in Patients With Neovascular Age-related Macular Degeneration Who Have Completed the CRTH258A2303 (TALON) Study

Completed· Novartis logo

Novartis·Phase 3·NCT04597632·248 enrolled

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)

Withdrawn· Novartis logo

Novartis·Phase 3·NCT04697953

Diabetic Macular Edema6 trials

Efficacy and Safety of Brolucizumab vs Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema

Completed· Novartis logo

Novartis·Phase 3·NCT03917472·517 enrolled

To Compare Brolucizumab to Aflibercept in Chinese Patients With Visual Impairment Due to Diabetic Macular Edema

Completed· Novartis logo

Novartis·Phase 3·NCT04058067·266 enrolled

A Study of the Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema

Completed· Novartis logo

Novartis·Phase 3·NCT03481660·360 enrolled

Show 3 more trials

Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema

Withdrawn· Novartis logo

Novartis·Phase 3·NCT04079231

Post Marketing Study to Evaluate the Safety and Effectiveness of Brolucizumab in Patients With Diabetic Macular Edema.

Active, not recruiting· Novartis logo

Novartis·Phase 4·NCT05959304·63 enrolled

Study of Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema

Completed· Novartis logo

Novartis·Phase 3·NCT03481634·566 enrolled

Efficacy and Safety3 trials

Efficacy and Safety of RTH258 Versus Aflibercept - Study 2

Completed·AAlcon Research·Phase 3·NCT02434328·1,048 enrolled

Study to Assess the Efficacy and Safety of Brolucizumab 6mg Compared to Aflibercept 2 mg in a Treat-to-control Regimen (TALON)

Completed· Novartis logo

Novartis·Phase 3·NCT04005352·734 enrolled

Efficacy and Safety of RTH258 Versus Aflibercept - Study 1

Completed·AAlcon Research·Phase 3·NCT02307682·1,775 enrolled

Safety and Efficacy2 trials

Study of Safety and Efficacy of Brolucizumab 6 mg Drug Product Intended for Commercialization in Patients With nAMD

Completed· Novartis logo

Novartis·Phase 3·NCT03386474·151 enrolled

Study of Safety and Efficacy of Brolucizumab 6 mg Dosed Every 4 Weeks Compared to Aflibercept 2 mg Dosed Every 4 Weeks in Patients With Retinal Fluid Despite Frequent Anti-VEGF Injections

Terminated· Novartis logo

Novartis·Phase 3·NCT03710564·535 enrolled

Retinal Vein Occlusion2 trials

Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Patients With Visual Impairment Due to Macular Edema Secondary to Branch Retinal Vein Occlusion

Terminated· Novartis logo

Novartis·Phase 3·NCT03802630·450 enrolled

Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion

Terminated· Novartis logo

Novartis·Phase 3·NCT03810313·493 enrolled

12 more indications

Neovascular AMD1 trial

Treatment of Recalcitrant Neovascular AMD Using Brolocizumab With Immediate T&E

Completed·TThe University of Hong Kong·Phase 4·NCT05710471·30 enrolled

Prospective1 trial

Prospective triAl of Modified Treat-and-extend Regimens With BroLucizumab in pachychOroid Neovasculopathy

Unknown status·YYeungnam University College of Medicine·Phase 3·NCT05672979·36 enrolled

Proliferative Diabetic Retinopathy1 trial

Study of Efficacy and Safety of Brolucizumab Versus Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy

Completed· Novartis logo

Novartis·Phase 3·NCT04278417·689 enrolled

Polypoidal choroidal vasculopathy1 trial

Study Assessing the Efficacy and Safety of a Personalized Monotherapy Regimen of Brolucizumab in Patients With Symptomatic Macular Polypoidal Choroidal Vasculopathy

Completed· Novartis logo

Novartis·Phase 3·NCT05666804·148 enrolled

Optical Coherence Tomography1 trial

A Non-interventional Study to Assess the Influence of Automated Optical Coherence Tomography Image Enrichment With Segmentation Information on Disease Activity Assessment in Patients Treated With Licensed Anti- VEGF Injections

Completed· Novartis logo

Novartis··NCT04662944·494 enrolled

Treatment1 trial

Evaluation of Number of Patient Eyes That Remained on or Switched to Anti-VEGF Treatment After Initiation of Broluciumab

Completed· Novartis logo

Novartis··NCT05037396·9,457 enrolled

Observational Study1 trial

Observational Study to Evaluate Fluid Resolution and Effectiveness of Brolucizumab for nAMD in Portugal

Terminated· Novartis logo

Novartis··NCT04764656·81 enrolled

wAMD1 trial

Comparison of Rapid Aflibercept and Brolucizumab T&E in wAMD

Active, not recruiting·BBerner Augenklinik·N/A·NCT04932980·80 enrolled

Neovascular1 trial

BEOVU in the Treatment of Dystrophy-related Macular Neovascular Degeneration

Unknown status·—·Phase 4·NCT04690062·20 enrolled

Biomarkers1 trial

Study of Innovative Multimodal Imaging Biomarkers to Predict Anatomical Outcome in Naive Patients With wAMD Treated With Brolucizumab.

Completed· Novartis logo

Novartis·Phase 4·NCT04774926·122 enrolled

Neovascular Age-Related Macular Degeneration (nAMD)1 trial

OBservationaL stUdy to Evaluate Fluid reSolution and Effectiveness in Patients Receiving Beovu (Brolucizumab) Under KeY Treatment Schemes in Neovascular Age-related Macular Degeneration and Visual Impairment Due to Diabetic Macular Edema

Completed· Novartis logo

Novartis··NCT04543331·572 enrolled

Unspecified2 trials

Brolucizumab vs. Aflibercept for Retinal Angiomatous Proliferation

Withdrawn·FFaculty Hospital Kralovske Vinohrady·Phase 4·NCT04698850

Beovu Experience UZ Leuven

Unknown status·UUniversitaire Ziekenhuizen KU Leuven··NCT05220085·17 enrolled

Regulatory

FDA Approval Timeline[4]

Oct 7, 2019

BEOVU

NDA BLA761125

Oct 7, 2019

BEOVU

BLA BLA761125

Jun 9, 2020

BEOVU

NDA BLA761125

Feb 18, 2022

BEOVU

NDA BLA761125

Feb 18, 2022

BEOVU

NDA BLA761125

Feb 18, 2022

BEOVU

NDA BLA761125

Mar 9, 2022

BEOVU

NDA BLA761125

May 27, 2022

BEOVU

NDA BLA761125

Dec 19, 2022

BEOVU

NDA BLA761125

Sep 28, 2023

BEOVU

NDA BLA761125

Jul 29, 2024

BEOVU

NDA BLA761125

Sources

References

[1]
ClinicalTrials.gov — 35 trial records for Brolucizumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Brolucizumab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Brolucizumab. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA BLA761125). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: VEGF-a Inhibitor[2]
Modality: Monoclonal antibody[2]
Highest Phase: Approved[1]
Company: Novartis

Beovu

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2028

Trials by Indication[1]

Age-Related Macular Degeneration9 trials

Diabetic Macular Edema6 trials

Efficacy and Safety3 trials

Safety and Efficacy2 trials

Retinal Vein Occlusion2 trials

Neovascular AMD1 trial

Prospective1 trial

Proliferative Diabetic Retinopathy1 trial

Polypoidal choroidal vasculopathy1 trial

Optical Coherence Tomography1 trial

Treatment1 trial

Observational Study1 trial

wAMD1 trial

Neovascular1 trial

Biomarkers1 trial

Neovascular Age-Related Macular Degeneration (nAMD)1 trial

Unspecified2 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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