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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
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
RandomizedSHAM_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07158775A Phase 1/2 Study to Evaluate the Safety and Efficacy of Intravitreal Administration of BS01 in Patients With Geographic Atrophy Secondary to Dry AMDPHASE1 RECRUITING 40 — — Jan 8, 2026Dec 1, 2031Jan 23, 20261 United States
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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
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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 -
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 — 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, 2026NCT07158775studyFirstPostDate: changed