BEOVU (brolucizumab-dbll)
BEOVU is indicated for the treatment of Neovascular Age-Related Macular Degeneration; Diabetic Macular Edema.
How BEOVU Works
Brolucizumab functions by binding to the three major isoforms of vascular endothelial growth factor A (VEGF-A), including VEGF 110, VEGF 121, and VEGF 165. This binding prevents VEGF-A from interacting with its receptors, VEGFR-1 and VEGFR-2. By inhibiting these interactions, the drug suppresses endothelial cell proliferation, neovascularization, and vascular permeability.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2019-10-07
- Routes
- INTRAVITREAL
- Dosage Forms
- INJECTABLE
BEOVU Approval History
What BEOVU Treats
2 indicationsBEOVU is approved for 2 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Neovascular Age-Related Macular Degeneration
- Diabetic Macular Edema
BEOVU Target & Pathway
ProTarget
Receptors on blood vessel cells that respond to VEGF signals to form new blood vessels. Cancer cells exploit this pathway to ensure blood supply for tumor growth. Blocking VEGFRs prevents tumor angiogenesis and limits cancer progression.
Pathway Context
VEGFR on blood vessels is activated by VEGF to promote angiogenesis
A signaling protein that stimulates the formation of new blood vessels (angiogenesis). Tumors need blood supply to grow, so they secrete VEGF to create new vessels. Blocking VEGF starves tumors of oxygen and nutrients, inhibiting their growth.
BEOVU Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to BEOVU
3 of 10FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
12 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05959304 | CRTH258BIN01 | Ph 4 | completed | Post Marketing Study to Evaluate the Safety and Effectiveness of Brolucizumab in Patients With Diabetic Macular Edema. |
| NCT04679935 FALCON results posted | CRTH258ADE01 2019-004767-53 | Ph 4 | completed | Efficacy and Safety of Two Different Brolucizumab 6 mg Dosing Regimens in Neovascular Age-related Macular Degeneration |
| NCT04774926 IMAGINE results posted | CRTH258AIT04 2020-002452-20 | Ph 4 | completed | Study of Innovative Multimodal Imaging Biomarkers to Predict Anatomical Outcome in Naive Patients With wAMD Treated With Brolucizumab. |
| NCT03481660 KITE results posted | CRTH258B2302 2017-003960-11 | Ph 3 | completed | A Study of the Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema |
| NCT04597632 TALON Ext results posted | CRTH258A2303E1 2020-002349-40 | Ph 3 | completed | 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 |
| NCT04058067 KINGLET results posted | CRTH258B2304 | Ph 3 | completed | To Compare Brolucizumab to Aflibercept in Chinese Patients With Visual Impairment Due to Diabetic Macular Edema |
| NCT05710471 | Switch Study | Ph 4 | completed | Treatment of Recalcitrant Neovascular AMD Using Brolocizumab With Immediate T&E |
| NCT03481634 KESTREL results posted | CRTH258B2301 2017-004742-23 | Ph 3 | completed | Study of Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema |
| NCT03710564 MERLIN results posted | CRTH258AUS04 | Ph 3 | terminated | 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 |
| NCT03917472 KINGFISHER results posted | CRTH258B2305 2019-001004-37 | Ph 3 | completed | Efficacy and Safety of Brolucizumab vs Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema |
| NCT04697953 PEREGRINE | CRTH258ACA03 | Ph 3 | withdrawn | 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) |
| NCT04079231 BUZZARD | CRTH258BDE01 | Ph 3 | withdrawn | Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
BEOVU FDA Label Details
Indications & Usage
FDA Label (PDF)BEOVU is indicated for the treatment of Neovascular Age-Related Macular Degeneration; Diabetic Macular Edema.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment