Vabysmo

(Faricimab)

ApprovedMonoclonal antibody

Vabysmo is a monoclonal antibody that works as Ang-2/vegf-a Bispecific.[2] It is being used across 13 indications, with its most advanced program in Approved.[1]

Vabysmo is one of 144 bispecific antibody programs targeting Diabetic Macular Edema. It is currently in Approved.

Indications

Total Trials

Active Trials

143

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Diabetic Macular EdemaActive, not recruiting

Abnormality of the EyeActive, not recruiting

Cystoid Macular EdemaUnknown

Ocular Vascular DiseaseUnknown

Macular Retinal EdemaUnknown

Wet Macular DegenerationUnknown

Neovascular Age-Related Macular Degeneration (namd)Active, not recruiting

Macular DegenerationRecruiting

Proliferative Diabetic RetinopathyEnrolling by invitation

Diabetic Macular EdemaApproved

Active, not recruiting

Unknown

Abnormality of the EyePreclinical

Active, not recruiting

Cystoid Macular EdemaPreclinical

Unknown

Ocular Vascular DiseasePreclinical

Unknown

Macular Retinal EdemaPreclinical

Unknown

Wet Macular DegenerationPreclinical

Unknown

Neovascular Age-Related Macular Degeneration (namd)Approved

Active, not recruiting

Macular DegenerationApproved

Recruiting

Proliferative Diabetic RetinopathyApproved

Enrolling by invitation

Showing 10 of 13 indications

Competition

Competitive Landscape

350 competitors in Treatment

#DrugCompanyPhaseTrials

Vabysmo

Roche

Approved

2 2

Dexilant

Takeda

Preclinical

2 3

Alfenta

Jazz Pharmaceuticals

Preclinical

1 4

Niclocide

Bayer

Preclinical

1 5

Hivid

CConrado Roberto Hoffmann Filho

Preclinical

6 6

Valium

Akero Therapeutics

Preclinical

2 7

Lotemax

PPharmos

Preclinical

1 8

Norpramin

VValidus Pharmaceuticals

Preclinical

1 9

Barhemsys

Tibotec Pharmaceuticals, Ireland

Preclinical

1 10

Clomid

Ferring

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Post-ApprovalActive, not recruiting

Diabetic Macular Edema

NCT05610319

Q1 2027

ApprovedActive, not recruiting

Diabetic Macular Edema

NCT05224102

Post-ApprovalRecruiting

Macular Degeneration

NCT06742307

Phase 2Recruiting

Diabetic Macular Edema

NCT06908876

Q3 2027

ApprovedActive, not recruiting

Neovascular Age-Related Macular Degeneration (namd)

NCT06795048

Q4 2027

Active, not recruiting

Diabetic Macular Edema

NCT06439576

Clinical

Trials by Indication[1]

Diabetic Macular Edema12 trials

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 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 Faricimab (RO6867461) in Participants With Diabetic Macular Edema (YOSEMITE)

Completed· Roche logo

Roche·Phase 3·NCT03622580·940 enrolled

Show 9 more trials

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

Completed· Roche logo

Roche·Phase 2·NCT02699450·229 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 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

Intravitreal Faricimab in Diabetic Macular Edema With Limited Response to Aflibercept

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

A Phase I, Multicenter, Open-Label, Multiple-Ascending Dose Study of the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 Administered by Intravitreal Injection as Monotherapy and in Combination With Faricimab in Patients With Diabetic Macular Edema

Recruiting· Roche logo

Roche·Phase 1·NCT07425522·93 enrolled

A Phase IV, Multicenter, Open-Label, Single-Arm Study to Investigate Faricimab (RO6867461) Treatment Response in Treatment-Naive, Underrepresented Patients With Diabetic Macular Edema

Active, not recruiting· Roche logo

Roche·Approved·NCT05224102·218 enrolled

China Faricimab Real World Evidence: Evaluation of Faricimab Effectiveness, Safety and Treatment Pattern, in Diabetic Macular Edema, Retinal Vein Occlusion and Neovascular Age-Related Macular Degeneration: The Farseeing Study

Active, not recruiting· Roche logo

Roche··NCT06439576·1,000 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

Age-Related Macular Degeneration10 trials

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

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

Not yet recruiting·HHui Peng··NCT07088445·35 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

Show 7 more trials

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 (TENAYA)

Completed· Roche logo

Roche·Phase 3·NCT03823287·671 enrolled

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

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

Identification of Molecular Signals in Vitreous Humor Associated With Suboptimal Response to VEGF Inhibition in nAMD Within a Clinical Trial Setting

Recruiting·SSingapore National Eye Centre·Preclinical·NCT07249216·117 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

Proliferative Diabetic Retinopathy3 trials

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

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

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

A Randomized Clinical Trial Evaluating Combination Faricimab + PRP vs. Vitrectomy + Endolaser for Treatment of Proliferative Diabetic Retinopathy

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

Macular Degeneration3 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

A Phase IV, Prospective, Open-label, Single-arm Clinical Trial to Evaluate the Efficacy of Faricimab and Biomarker Assessment in Patients With Neovascular Age-related Macular Degeneration

Recruiting·JJunyeop Lee·Approved·NCT07367282·64 enrolled

Treatment2 trials

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

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

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

Completed·RRigshospitalet, Denmark··NCT06124677·46 enrolled

11 more indications

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

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

Efficacy2 trials

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

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

Neovascular Age-related Macular Degeneration2 trials

Real-World, Long-Term Data Collection to Gain Clinical Insights Into Roche Ophthalmology Products (VOYAGER STUDY)

Active, not recruiting· Roche logo

Roche··NCT05476926·6,000 enrolled

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

Active, not recruiting· Roche logo

Roche··NCT06680817·850 enrolled

Safety and Efficacy1 trial

Safety and Efficacy of Faricimab in Patients With NPDR

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

Radiation Retinopathy1 trial

A Trial Evaluating Intravitreal Faricimab (6.0 mg) Injections or Fluocinolone Acetonide (0.19 mg Intravitreal Implants vs Observation for Prevention of Visual Acuity Loss Due to Radiation Retinopathy

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

Neovascular Age-Related Macular Degeneration (nAMD)1 trial

A Phase IIIb/IV, Multicenter, Randomized, Open-Label, Two-Arm Study to Investigate the Efficacy, Safety, and Durability of Faricimab Administered up to Every 24 Weeks in Patients With Neovascular Age-Related Macular Degeneration

Active, not recruiting· Roche logo

Roche·Approved·NCT06795048·274 enrolled

Choroidal Neovascularization Secondary to Pathologic Myopia1 trial

A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Choroidal Neovascularization Secondary to Pathologic Myopia

Completed· Roche logo

Roche·Phase 3·NCT06176352·280 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

Jan 27, 2023

VABYSMO

NDA BLA761235

Oct 26, 2023

VABYSMO

NDA BLA761235

Jul 3, 2024

VABYSMO

NDA BLA761235

Apr 9, 2026

VABYSMO

NDA 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 (NDA 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

Q4 2026

Q1 2027

Q3 2027

Q4 2027

Trials by Indication[1]

Diabetic Macular Edema12 trials

Age-Related Macular Degeneration10 trials

Proliferative Diabetic Retinopathy3 trials

Macular Degeneration3 trials

Treatment2 trials

Polypoidal choroidal vasculopathy2 trials

Retinal Vein Occlusion2 trials

Efficacy2 trials

Neovascular Age-related Macular Degeneration2 trials

Safety and Efficacy1 trial

Macular Edema1 trial

Ocular Inflammation1 trial

Radiation Retinopathy1 trial

Neovascular Age-Related Macular Degeneration (nAMD)1 trial

Choroidal Neovascularization Secondary to Pathologic Myopia1 trial

Central Serous Chorioretinopathy1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Key Publications[5]

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