Vabysmo

(Faricimab)

ApprovedMonoclonal antibody

Vabysmo is a monoclonal antibody that works as Ang-2/vegf-a Bispecific.[2] It is being used across 16 indications, with its most advanced program in Approved.[1]

Vabysmo is one of 175 bispecific antibody programs targeting Choroidal Neovascularization. It is currently in Approved.

Indications

Total Trials

Active Trials

174

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Choroidal NeovascularizationActive, not recruiting

Proliferative Diabetic RetinopathyActive, not recruiting

Cystoid Macular EdemaUnknown

Wet Macular DegenerationUnknown

RetinopathyActive, not recruiting

Macular DegenerationActive, not recruiting

Macular Retinal EdemaUnknown

Abnormality of the EyeActive, not recruiting

Retinal Vein OcclusionActive, not recruiting

Ocular Vascular DiseaseUnknown

Choroidal NeovascularizationPhase 2

Active, not recruiting

Proliferative Diabetic RetinopathyApproved

Active, not recruiting

Cystoid Macular EdemaPreclinical

Unknown

Wet Macular DegenerationPreclinical

Unknown

RetinopathyPhase 3

Active, not recruiting

Macular DegenerationPhase 1

Active, not recruiting

Macular Retinal EdemaPreclinical

Unknown

Abnormality of the EyePreclinical

Active, not recruiting

Retinal Vein OcclusionPhase 3

Active, not recruiting

Ocular Vascular DiseasePreclinical

Unknown

Showing 10 of 16 indications

Competition

Competitive Landscape

237 competitors in Age-Related Macular Degeneration

#DrugCompanyPhaseTrials

Lucentis

Roche

Phase 3

64 2

Eylea

Regeneron

Phase 3

44 3

Vabysmo

Roche

Approved

13 4

Beovu

Novartis

Phase 3

10 5

Macugen

Pfizer

Phase 3

6 6

Avastin

BBio-Thera Solutions

Phase 3

18 7

Retaane

AAlcon Research

Phase 3

5 8

Kenalog

BBausch Health Americas, Inc.

Phase 3

2 9

Forzinity

SStealth BioTherapeutics Inc.

Phase 3

2 10

Luye Pharma Conbercept

CChengdu Kanghong Biotech Co., Ltd.

Phase 3

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

Timeline

Expected Milestones

Q3 2026

Recruiting

Age-Related Macular Degeneration

NCT06271330

Q4 2026

Post-ApprovalActive, not recruiting

Diabetic Macular Edema

NCT05610319

Q1 2027

Post-ApprovalActive, not recruiting

Diabetic Macular Edema

NCT05224102

Post-ApprovalRecruiting

Macular Degeneration

NCT06742307

Phase 2Recruiting

Diabetic Macular Edema

NCT06908876

Q3 2027

Post-ApprovalActive, not recruiting

Age-Related Macular Degeneration

NCT06795048

Clinical

Trials by Indication[1]

Age-Related Macular Degeneration13 trials

Faricimab for High-frequent Aflibercept Treated Neovascular Age-related Macular Degeneration

Completed·MMedical University of Graz·Phase 4·NCT05941715·70 enrolled

A Proof-of-Concept Study of Faricimab (RO6867461) in Participants With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)

Completed· Roche logo

Roche·Phase 2·NCT02484690·273 enrolled

A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (TENAYA)

Completed· Roche logo

Roche·Phase 3·NCT03823287·671 enrolled

Show 10 more trials

A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration

Completed· Roche logo

Roche·Phase 3·NCT04777201·1,036 enrolled

Switching to Faricimab in Neovascular Age-related Macular Degeneration Resistant to Both Aflibercept and Ranibizumab

Completed·RRigshospitalet, Denmark··NCT06231121·13 enrolled

A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (LUCERNE)

Completed· Roche logo

Roche·Phase 3·NCT03823300·658 enrolled

Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)

Recruiting· Roche logo

Roche··NCT06439576·1,000 enrolled

A Study to Determine the Efficacy, Safety, and Durability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration

Active, not recruiting· Roche logo

Roche·Phase 4·NCT06795048·274 enrolled

Therapeutic Prospects of Faricimab Injection for Patients Affected by Neovascular Age-Related Macular Degeneration

Not yet recruiting·HHui Peng··NCT07088445·35 enrolled

Identification of Molecular Signals in Vitreous Humor Associated With Suboptimal Response to Vascular Endothelial Growth Factor (VEGF) Inhibition in Neovascular Age-related Macular Degeneration (nAMD) Within a Clinical Trial Setting

Recruiting·SSingapore National Eye Centre·N/A·NCT07249216·117 enrolled

Durability of Three Monthly Loading Doses With Faricimab in Treatment-naïve Neovascular Age-related Macular Degeneration

Active, not recruiting·RRigshospitalet, Denmark··NCT06890026·828 enrolled

Evaluate the Efficacy of Faricimab in Patients With Neovascular Age-related Macular Degeneration

Not yet recruiting·JJunyeop Lee·Phase 4·NCT07367282·64 enrolled

A Multicenter Real-life Observational Retrospective Study Switched Aflibercept or Ranibizumab to Faricimab in Patients With Refractory or Dependent Exudative AMD

Recruiting·NNantes University Hospital··NCT06271330·100 enrolled

Diabetic Macular Edema11 trials

Intravitreal Faricimab in Diabetic Macular Edema With Limited Response to Aflibercept

Unknown status·VVista Klinik·Phase 4·NCT05610488·30 enrolled

A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema

Completed· Roche logo

Roche·Phase 3·NCT03622593·951 enrolled

A Study to Investigate Aqueous Humor and Multimodal Imaging Biomarkers in Treatment-Naïve Participants With Diabetic Macular Edema Treated With Faricimab

Completed· Roche logo

Roche·Phase 2·NCT04597918·99 enrolled

Show 8 more trials

A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Diabetic Macular Edema

Completed· Roche logo

Roche·Phase 3·NCT04432831·1,479 enrolled

A Study to Evaluate the Efficacy and Safety of IBI302 inSubjects With Diabetic Macular Edema（DME）

Recruiting·IInnovent Biologics Technology Limited (Shanghai R&D Center)·Phase 2·NCT06908876·150 enrolled

A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 in Participants With Diabetic Macular Edema (DME)

Recruiting· Roche logo

Roche·Phase 1·NCT07425522·93 enrolled

Treat & Extend Versus Fixed Dosing with Faricimab for Management of Diabetic Macular Edema: a Pragmatic, Multi-center, Open-label, Randomized, Controlled Trial

Active, not recruiting·MMcMaster University·Phase 4·NCT05610319·446 enrolled

A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema (YOSEMITE)

Completed· Roche logo

Roche·Phase 3·NCT03622580·940 enrolled

A Study of Faricimab (RO6867461) in Participants With Center-Involving Diabetic Macular Edema

Completed· Roche logo

Roche·Phase 2·NCT02699450·229 enrolled

A Study to Investigate Faricimab Treatment Response in Treatment-Naive, Underrepresented Patients With Diabetic Macular Edema

Active, not recruiting· Roche logo

Roche·Phase 4·NCT05224102·218 enrolled

A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO7446603 Administered Alone or in Combination With Aflibercept or Faricimab in Patients With Diabetic Macular Edema

Completed· Roche logo

Roche·Preclinical·NCT06850922·388 enrolled

Treatment2 trials

Single Injection of Faricimab for nAMD With Persisting Fluid Despite Frequent Aflibercept Treatments

Completed·RRigshospitalet, Denmark··NCT06124677·46 enrolled

Comparing Efficacy of 8-Week and 12-Week Faricimab Initial Follow-Up Treatment Intervals

Recruiting·FFaculty Hospital Kralovske Vinohrady·Phase 4·NCT06875245·100 enrolled

Proliferative Diabetic Retinopathy2 trials

Biological Changes in Fibrovascular Membranes of Patients With Proliferative Diabetic Retinopathy Following Faricimab Injection

Completed·BBojie Hu·N/A·NCT07144865·8 enrolled

Pre-operative Vabysmo in Patients With Non-clearing Vitreous Hemorrhage Secondary to Proliferative Diabetic Retinopathy

Enrolling by invitation·UUniversity of Colorado, Denver·Phase 4·NCT06191094·100 enrolled

Retinal Vein Occlusion2 trials

A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Branch Retinal Vein Occlusion

Completed· Roche logo

Roche·Phase 3·NCT04740905·553 enrolled

A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion

Completed· Roche logo

Roche·Phase 3·NCT04740931·729 enrolled

12 more indications

Efficacy2 trials

A Phase 1b Study to Assess the Safety, Tolerability, Pharmacokinetics, and Exploratory Efficacy of Intravitreal OLN324

Completed·OOllin Biosciences, Inc.·Phase 1·NCT07484074·164 enrolled

Evaluation of Therapeutic Efficacy of Faricimab for Clinical AMD, DME, and RVO Patients

Recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 2/3·NCT06572553·30 enrolled

Polypoidal choroidal vasculopathy2 trials

Study to Investigate the Efficacy, Safety and Durability of Faricimab in Caucasian Patients With Polypoidal Choroidal Vasculopathy (MONDEGO)

Recruiting·AAssociation for Innovation and Biomedical Research on Light and Image·Phase 4·NCT06709339·120 enrolled

Efficacy and Durability of a Personalized Treat-and-extend Regimen of Faricimab for Treatment-naive Polypoidal Choroidal Vasculopathy

Recruiting·YYeungnam University College of Medicine·Phase 3·NCT07461441·50 enrolled

Macular Degeneration2 trials

Study to Evaluate Faricimab (RO6867461; RG7716) for Extended Durability in the Treatment of Neovascular Age Related Macular Degeneration

Completed· Roche logo

Roche·Phase 2·NCT03038880·76 enrolled

Faricimab Quarterly Maintenance for Neovascular Age Related Macular Degeneration

Recruiting·HHospital Authority, Hong Kong·Phase 4·NCT06742307·40 enrolled

Safety and Efficacy1 trial

Safety and Efficacy of Faricimab in Patients With NPDR

Completed·GGreater Houston Retina Research·Phase 2·NCT05681884·179 enrolled

Choroidal Neovascularization1 trial

A Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Choroidal Neovascularization Secondary to Pathologic Myopia

Active, not recruiting· Roche logo

Roche·Phase 3·NCT06176352·280 enrolled

Retinopathy1 trial

Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of VA Loss Due to Radiation Retinopathy

Recruiting·JJaeb Center for Health Research·Phase 3·NCT05844982·600 enrolled

Vitrectomy1 trial

Faricimab + PRP vs. Vitrectomy + Endolaser for Treatment of PDR

Recruiting·JJaeb Center for Health Research·Phase 3·NCT06790784·426 enrolled

Real-world Study1 trial

A Real-World Study to Gain Clinical Insights Into Roche Ophthalmology Products

Active, not recruiting· Roche logo

Roche··NCT05476926·6,000 enrolled

Macular Edema1 trial

Intravitreal Faricimab in Patients With Refractory Macular Edema

Completed·UUniversity of Baghdad·Phase 2·NCT07093385·43 enrolled

Ocular Inflammation1 trial

Real-world Incidence of Intraocular Inflammation Following Intravitreal Faricimab Therapy

Completed·RRigshospitalet, Denmark··NCT06902207·6,053 enrolled

Neovascular Age-related Macular Degeneration1 trial

Real-World, Long-Term Data Collection to Gain Clinical Insights Into Faricimab (FaReal Study)

Active, not recruiting· Roche logo

Roche··NCT06680817·850 enrolled

Central Serous Chorioretinopathy1 trial

A Randomized, Double-Masked, Sham-Controlled Clinical Trial of Intravitreal Faricimab for Chronic Central Serous Chorioretinopathy With or Without Secondary Macular Neovascularization: Study Protocol for a Randomised, Double-Masked Trial

Not yet recruiting·SSingapore National Eye Centre·Phase 2·NCT07681167·50 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 28, 2022

VABYSMO

BLA BLA761235

Sources

References

[1]
ClinicalTrials.gov — 45 trial records for Faricimab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Faricimab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Faricimab. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA761235). U.S. Food & Drug Administration.
[5]
PubMed — 2 publications indexed for Faricimab. U.S. National Library of Medicine.
[6]
SEC EDGAR — Roche company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Ang-2/vegf-a Bispecific[2]
Modality: Monoclonal antibody[2]
Highest Phase: Approved[1]
Company: Roche

Key Publications[5]

Faricimab for Neovascular AMD: TENAYA and LUCERNE 2-Year Results

LancetJan 28, 2023DOI: 10.1016/S0140-6736(23)00068-X

Faricimab in Diabetic Macular Edema: YOSEMITE/RHINE Results

N Engl J MedAug 4, 2022DOI: 10.1056/NEJMoa2206411

Vabysmo

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q1 2027

Q3 2027

Trials by Indication[1]

Age-Related Macular Degeneration13 trials

Diabetic Macular Edema11 trials

Treatment2 trials

Proliferative Diabetic Retinopathy2 trials

Retinal Vein Occlusion2 trials

Efficacy2 trials

Polypoidal choroidal vasculopathy2 trials

Macular Degeneration2 trials

Safety and Efficacy1 trial

Choroidal Neovascularization1 trial

Retinopathy1 trial

Vitrectomy1 trial

Real-world Study1 trial

Macular Edema1 trial

Ocular Inflammation1 trial

Neovascular Age-related Macular Degeneration1 trial

Central Serous Chorioretinopathy1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Key Publications[5]

Related News