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VIS-101

Phase 1

Diabetic Macular Edema | Monoclonal antibody | Ophthalmology |NovaBridge Biosciences|Trials Updated: Sep 1, 2026

VIS-101 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Jul 2022

VIS-101 target and mechanism

Molecular targetVEGF-A and ANG2
ModalityMonoclonal antibody

Also known as ASKG712, VIS-101 High concentration, AM712

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials3
Total Enrollment310

FDA Designations

No designations recorded

VIS-101 clinical trials

VIS-101 · 3 trials · 3 indications

Phase 2 1Phase 1 2
NCT07798375A Study to Evaluate the Efficacy and Safety of VIS-101 in Participants With Neovascular Age-Related Macular DegenerationNeovascular Age Related Macular Degeneration(nAMD)
NOT YET_RECRUITING244 Analytics
PHASE2NOT YET_RECRUITING
A Study to Evaluate the Efficacy and Safety of VIS-101 in Participants With Neovascular Age-Related Macular Degeneration
Neovascular Age Related Macular Degeneration(nAMD)Unlock trial analytics

Study Endpoints

Primary Endpoints

Change in BCVA from baseline to average of Weeks 20, 24, and 28
From Baseline through Week 28

BCVA as measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity

Incidence of ocular adverse events (AEs) of the study eyes
24 weeks

Any relevant ocular observations derived from best corrected visual acuity (BCVA), intraocular pressure, slitlamp examination, ophthalmoscopy, optical coherence tomography (OCT), fundus photography, and angiography

Incidence of non-ocular AEs
24 weeks

Any clinical safety observations assessed by physical examination, vital signs, electrocardiograph (ECG) and clinical laboratory tests

Incidence of non-ocular adverse events (AEs)
Part 1: 6 weeks; Part 2: 20 weeks; Part 3: up to 36 weeks

Any changes of clinical safety observations assessed by vital signs, electrocardiograph (ECG), clinical laboratory tests and physical examination

Secondary Endpoints

Change in BCVA from baseline
Throughout week 48
Dosing interval
Throughout week 48
Number of injections
Throughout week 44
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
VIS-101 6.0mg Low concentrationEXPERIMENTALVIS-101 will be administered by intravitreal injection into the study eye at intervals as specified in the study protocol.
VIS-101 6.0mg High concentrationEXPERIMENTALVIS-101 will be administered by intravitreal injection into the study eye at intervals as specified in the study protocol.
VIS-101 9.0mg High concentrationEXPERIMENTALVIS-101 will be administered by intravitreal injection into the study eye at intervals as specified in the study protocol.
AfliberceptACTIVE_COMPARATORAflibercept will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive months, followed by once every 8 weeks (Q8W).
ASKG712EXPERIMENTALMultiple doses of ASKG712 by intravitreal injection

Interventions

NameTypeDescription
VIS-101 6.0mg High concentrationBIOLOGICALVIS-101 will be administered by intravitreal injection into the study eye at intervals as specified in the study protocol.
VIS-101 9.0mg High concentrationBIOLOGICALVIS-101 will be administered by intravitreal injection into the study eye at intervals as specified in the study protocol.
Aflibercept (Eylea)BIOLOGICALAflibercept will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive months, followed by once every 8 weeks (Q8W).
ASKG712BIOLOGICALASKG712 is a recombinant anti-VEGF humanized monoclonal antibody and Ang-2 antagonist peptide fusion protein, which has high specificity for the binding of VEGF-A and Ang-2.
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Eligibility Criteria

Age Range50 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: 1. Willingness to sign the informed consent form, aged ≥50 years (on Day 0 of dosing), with no gender restrictions 2. Able to adhere to the study protocol per the Investigator judgment 3. Female participants of childbearing potential (WOCBP) or male participants with partners wh...

Countries:China
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Frequently asked questions about VIS-101

What is VIS-101?

VIS-101 is an investigational monoclonal antibody developed by NovaBridge Biosciences for retinal diseases. It is being studied in ophthalmology for two conditions: diabetic macular edema and neovascular age-related macular degeneration. It is a clinical-stage asset, not an approved therapy, and has been tested in early-phase trials in China.

What is VIS-101 used for?

VIS-101 is being developed for the treatment of diabetic macular edema and neovascular age-related macular degeneration, two retinal conditions involving abnormal blood vessel growth and leakage. Both indications are in clinical development, so VIS-101 is not yet an approved treatment for either condition.

What does VIS-101 target?

VIS-101 targets both VEGF-A and ANG2, two signaling proteins involved in angiogenesis and vascular instability in the retina. Dual targeting of these pathways is the mechanism under investigation for reducing abnormal vessel growth and leakage in diabetic macular edema and neovascular age-related macular degeneration.

Who makes VIS-101?

VIS-101 is developed by NovaBridge Biosciences, which trades under the ticker NBP. The company is advancing the monoclonal antibody across ophthalmology indications, with clinical work conducted under the ASKG712 designation in China before the program moved into later-stage planning.

What phase is VIS-101 in?

VIS-101 is in Phase 1 development overall, with completed Phase 1 studies in diabetic macular edema and neovascular age-related macular degeneration. A Phase 2 study in neovascular age-related macular degeneration is planned but not yet recruiting. VIS-101 is investigational and has not been approved by the FDA.

What clinical trials is VIS-101 in?

VIS-101 has been studied in NCT05940428, a completed Phase 1 trial in diabetic macular edema with 10 participants in China, and NCT05456828, a completed Phase 1 trial in neovascular age-related macular degeneration with 56 participants in China. A Phase 2 trial, NCT07798375, is planned in neovascular age-related macular degeneration with 244 participants and is not yet recruiting.

Is VIS-101 the same as ASKG712?

Yes, ASKG712 is an alternative name for VIS-101, the monoclonal antibody developed by NovaBridge Biosciences. The Phase 1 trials in China were run under the ASKG712 designation, while the program is now referred to as VIS-101, including a high concentration 6.0 mg formulation.