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Tarcocimab tedromer

Phase 3

Wet Age-related Macular Degeneration | Small molecule | Ophthalmology |Kodiak Sciences Inc|Last Updated: Apr 29, 2026

Target and mechanism

Molecular targetVEGF-A
Target class-Mab (Antibody)
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment675

FDA Designations

No designations recorded

Clinical trial landscape

Tarcocimab tedromer · 1 trial · 1 indication

Phase 3 1
NCT06556368A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) - DAYBREAKWet Age-related Macular Degeneration
ACTIVE NOT_RECRUITING675 Analytics
PHASE3ACTIVE NOT_RECRUITING
A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) - DAYBREAK
Wet Age-related Macular DegenerationUnlock trial analytics

Study Endpoints

Primary Endpoints

Best corrected visual acuity (BCVA)
Week 48

Mean change in BCVA from Day 1 to Year 1

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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Tarcocimab tedromer 5 mg (KSI-301)EXPERIMENTALIntravitreal injection of tarcocimab tedromer once every 4 weeks for 4 monthly doses followed by individualized dosing every 4 to 24 weeks.
Tabirafusp tedromer 5 mg (KSI-501)EXPERIMENTALIntravitreal injection of tabirafusp tedromer once every 4 weeks for 4 monthly doses followed by every-8-week dosing with additional individualized dosing (up to monthly dosing)
Aflibercept 2 mgACTIVE_COMPARATORIntravitreal injection of aflibercept once every 4 weeks for 3 monthly doses followed by every-8-week dosing

Interventions

NameTypeDescription
Tarcocimab tedromerDRUGIntravitreal injection
Tabirafusp tedromerDRUGIntravitreal injection
AfliberceptDRUGIntravitreal injection
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Eligibility Criteria

Age Range50 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites72

Inclusion Criteria: * Active, treatment-naïve choroidal neovascularization (CNV) secondary to AMD, including subfoveal, juxtafoveal, and extrafoveal lesions, or retinal angiomatous proliferations (RAP) lesions with a CNV component that affects the central subfield, as evidenced by FA or OCT in the ...

Countries:United StatesPuerto Rico
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Frequently asked questions about Tarcocimab tedromer

What is Tarcocimab tedromer used for?

Tarcocimab tedromer is an investigational antibody being developed for the treatment of wet age-related macular degeneration (wAMD). It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.

What does Tarcocimab tedromer target?

Tarcocimab tedromer is an antibody, classified as a -mab, that is being studied for its efficacy and safety in treating wet age-related macular degeneration. The specific molecular target is not disclosed in the available information.

Who is developing Tarcocimab tedromer?

Tarcocimab tedromer is being developed by Kodiak Sciences Inc, a biopharmaceutical company listed on the stock exchange under the ticker symbol KOD.

What phase is Tarcocimab tedromer in?

Tarcocimab tedromer is currently in Phase 3 clinical development. It is an investigational drug and has not yet received approval from regulatory agencies for the treatment of wet age-related macular degeneration.

What clinical trials is Tarcocimab tedromer in?

Tarcocimab tedromer is being evaluated in a Phase 3 clinical trial with the identifier NCT06556368, known as the DAYBREAK study. This randomized, double-blind, active-controlled trial compares tarcocimab tedromer and tabirafusp tedromer against aflibercept in participants with wet age-related macular degeneration.

Is Tarcocimab tedromer the same as Tabirafusp tedromer?

No, tarcocimab tedromer and tabirafusp tedromer are distinct investigational drugs. Both are being studied in the same Phase 3 clinical trial (NCT06556368) for wet age-related macular degeneration, but they are separate molecules with different properties.