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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

Target and mechanism

Molecular targetChronosFP
ModalityMonoclonal antibody

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)Unlock trial analytics
PHASE1RECRUITING
BS01 in Patients With Retinitis Pigmentosa
Retinitis PigmentosaUnlock trial analytics

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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Frequently asked questions about BS01

What is BS01 used for?

BS01 is an investigational monoclonal antibody being developed for geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD) and retinitis pigmentosa. It is administered via intravitreal injection and is currently in Phase 1 clinical trials.

What does BS01 target?

BS01 targets ChronosFP, a molecular target involved in the disease pathways of geographic atrophy and retinitis pigmentosa. By binding to ChronosFP, BS01 aims to modulate the underlying mechanisms of these retinal conditions.

Who makes BS01?

BS01 is being developed by Sight Sciences, Inc., a company traded on the NASDAQ under the ticker symbol SGHT. The company is conducting clinical trials to evaluate the safety and efficacy of BS01 in patients with retinal diseases.

What phase is BS01 in?

BS01 is in Phase 1 clinical development. It is not yet approved by the FDA and remains investigational. Two Phase 1 trials are currently recruiting patients to assess its safety and efficacy.

What clinical trials is BS01 in?

BS01 is being studied in two Phase 1 trials. NCT07158775 evaluates BS01 in geographic atrophy secondary to dry AMD with 40 participants, and NCT04278131 evaluates BS01 in retinitis pigmentosa with 20 participants. Both trials are recruiting in the United States.