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ABBV-6628

Phase 1

Geographic Atrophy | Small molecule | Ophthalmology |AbbVie Inc.|Last Updated: Feb 12, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment66
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07160179Study to Assess the Adverse Events and How Intravitreal ABBV-6628 Moves Through the Body of Adult Participants With Geographic Atrophy Secondary to Age-Related Macular DegenerationPHASE1 RECRUITING 66Aug 13, 2025Oct 1, 2029Feb 12, 20264 United States
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Study Endpoints
Primary Endpoints
Number of Participants Experiencing Adverse Events
Up to approximately 25 months

An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

Number of Participants with Abnormal Change in Physical Examinations
Up to approximately 25 months

Number of participants with abnormal change in physical examinations in areas like cardiovascular, respiratory, gastrointestinal, and neurological systems will be assessed.

Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements
Up to approximately 25 months

Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.

Change From Baseline in Electrocardiograms (ECGs)
Up to approximately 25 months

12-lead resting ECGs will be recorded. Parameters include heart rate, PR interval, QT interval, QRS duration, and QT interval corrected using Fridericia's formula (QTcF).

Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed
Up to approximately 25 months

Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed.

Change from baseline in Best Corrected Visual Acuity (BCVA)
Up to approximately 25 months

BCVA measured by Early Treatment Diabetic Retinopathy Study (ETDRS) (normal luminance and low luminance visual acuity)

Change in Slit lamp biomicroscopy assessment
Up to approximately 25 months

Changes in Slit lamp biomicroscopy assessed by the physician will be assessed.

Change in Intraocular pressure (IOP)
Up to approximately 25 months

Measured by using Goldmann applanation tonometry (GAT) or hand-held tonometer

Change in Lens examination assessment
Up to approximately 25 months

Changes in Lens examination assessed by the physician will be assessed.

Change in Ophthalmoscopy assessment
Up to approximately 25 months

Changes in Ophthalmoscopy assessed by the physician will be assessed.

Change in fundus autofluorescence (FAF) imaging assessed by Investigator
Up to approximately 25 months

Fundus autofluorescence (FAF) imaging assessed by Investigator

Change in Retinal evaluation
Up to approximately 25 months

Measured by color fundus photography (CFP) imaging assessed by Investigator

Change in spectral domain optical coherence tomography (SD-OCT)
Up to approximately 25 months

Spectral domain optical coherence tomography (SD-OCT)

Change in Fluorescein angiography (FA) assessed by Investigator.
Up to approximately 25 months

Fluorescein angiography (FA) assessed by Investigator

Change in choroidal neovascularization (CNV) assessed by Investigator.
Up to approximately 25 months

Choroidal Neovascularization (CNV) assessed by Investigator.

Percentage of Participants with Clinically Significant Post-treatment Administration Assessment (study eye only) Findings as Assessed by the Investigator
Up to approximately 25 months

Post-treatment Administration Assessment (study eye only)

Maximum Serum Concentration (Cmax) of ABBV-6628
Up to approximately 25 months

Cmax of ABBV-6628

Time to Cmax (Tmax) of ABBV-6628
Up to approximately 25 months

Tmax of ABBV-6628

Area Under the Concentration-Time Curve From zero to the last measurable Timepoint (AUC0-Tlast) of ABBV-6628
Up to approximately 25 months

AUC0-Tlast of ABBV-6628

Stage 2-Trough serum concentration immediately before next dose (Ctrough) of ABBV-6628
Up to approximately 12 months

Ctrough of ABBV-6628

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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ABBV-6628: Stage 1-Cohort 1EXPERIMENTALParticipants will receive a single dose of ABBV-6628 in Cohort 1 on day 1.
ABBV-6628: Stage 1 -Cohort 2EXPERIMENTALParticipants will receive a single dose of ABBV-6628 in Cohort 2 on day 1.
ABBV-6628: Stage 1 -Cohort 3EXPERIMENTALParticipants will receive a single dose of ABBV-6628 in Cohort 3 on day 1.
ABBV-6628: Stage 1 -Cohort 4EXPERIMENTALParticipants will receive ABBV-6628 in Cohort 4 on day 1 and month 2.
ABBV-6628: Stage 2EXPERIMENTALParticipants will receive ABBV-6628 for approximately 22 months followed by 3 months of follow-up.
SYFOVRE: Stage 2EXPERIMENTALParticipants will receive SYFOVRE for approximately 22 months followed by 3 months of follow-up.
Interventions
NameTypeDescription
ABBV-6628DRUGIntravitreal injection
SYFOVREDRUGIntravitreal injection
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Eligibility Criteria
Age Range50 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: Stage 1 and Stage 2 -Diagnosed with Geographic atrophy (GA) secondary to age-related macular degeneration (AMD) in the study eye. Stage 1 * Foveal or non-foveal GA with total GA lesion area ≥ 0.5 DA (1.25 mm2) in the study eye, as assessed by the investigator at Screening and...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07160179primaryCompletionDate: changed
LOWMay 24, 2026NCT07160179studyFirstPostDate: changed