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BS01

Phase 1

Geographic Atrophy (GA) Secondary to Dry Age-related Macular Degeneration (AMD) | Monoclonal antibody | Ophthalmology |Sight Sciences, Inc.|Last Updated: Jan 23, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedSHAM_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical trial landscape

BS01 · 2 trials · 2 indications

Phase 1 2
NCT07158775A Phase 1/2 Study to Evaluate the Safety and Efficacy of Intravitreal Administration of BS01 in Patients With Geographic Atrophy Secondary to Dry AMDGeographic Atrophy (GA) Secondary to Dry Age-related Macular Degeneration (AMD)
RECRUITING40 Analytics
NCT04278131BS01 in Patients With Retinitis PigmentosaRetinitis Pigmentosa
RECRUITING20 Analytics
PHASE1RECRUITING
A Phase 1/2 Study to Evaluate the Safety and Efficacy of Intravitreal Administration of BS01 in Patients With Geographic Atrophy Secondary to Dry AMD
Geographic Atrophy (GA) Secondary to Dry Age-related Macular Degeneration (AMD)
NCT0715877540
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PHASE1RECRUITING
BS01 in Patients With Retinitis Pigmentosa
Retinitis Pigmentosa
NCT0427813120
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Study Endpoints
Primary Endpoints
[Phase 1] Number of the dose limiting toxicities (DLTs), incident and severity of ocular and non-ocular Study Drug-related adverse events (SDAE), treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
12 months
[Phase 2] Change from baseline in BCVA (Best Corrected Visual Acuity)
12 months
Primary Outcome Measure
12 months

Number of subjects with adverse events, changes in hematology/chemistry

Secondary Endpoints
Secondary Outcome Measures
12 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BS01 (low dose)EXPERIMENTAL -
Sham controlSHAM_COMPARATOR -
BS01 (high dose)EXPERIMENTAL -
Cohort 1EXPERIMENTALBSO1 Cohort 1 dose
Cohort 2EXPERIMENTALBS01 Cohort 2 dose
Cohort 3EXPERIMENTALBS01 Cohort 3 dose
Cohort 4EXPERIMENTALBS01 Cohort4 dose
Cohort 5EXPERIMENTALBS01 Cohort4 dose
Cohort 6EXPERIMENTALTreat opposite eye
Interventions
NameTypeDescription
BS01BIOLOGICALa recombinant adeno-associated virus vector expressing ChronosFP (AAV2-CAGChronosFP)
Sham procedure controlOTHERSham procedure without needle
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Eligibility Criteria
Age Range50 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: General Inclusion Criteria 1. Signed informed consent obtained before screening. 2. Men or women between 50 and 85 years of age inclusive at the time of signing the informed consent. Ophthalmic Inclusion Criteria 1. Geographic atrophy with some macula foveal involvement secon...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT04278131studyFirstPostDate: changed
LOWMay 24, 2026NCT07158775studyFirstPostDate: changed