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Privosegtor

Phase 3

Optic Neuritis | Small molecule | Ophthalmology |Oculis Holding AG|Last Updated: Jun 3, 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-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment210
FDA Designations
BREAKTHROUGH_THERAPYORPHAN_DRUG
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07623668Privosegtor Investigation in Optic Neuropathies Efficacy Evaluation ResearchPHASE3 RECRUITING 210May 28, 2026Dec 1, 2028Jun 3, 20261 United States
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Study Endpoints
Primary Endpoints
Proportion of participants achieving at least 15-letter gain from baseline in low contrast visual acuity (LCVA).
3 months
Secondary Endpoints
Proportion of participants achieving at least 30-letter gain from baseline in LCVA.
3 months
Mean change from baseline in LCVA.
3 months
Mean change from baseline in the ganglion cell - inner plexiform layer (GCIPL) thickness.
3 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PrivosegtorEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
PrivosegtorDRUGPrivosegtor (OCS-05) 3 mg/kg/day IV for 5 treatment days
MethylprednisoloneDRUGMethylprednisolone 1 g/day IV for 5 treatment days
PlaceboOTHER0.9% sodium chloride (NaCl) solution IV for 5 treatment days
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersNo
Study Sites1

Key Inclusion Criteria: * Adult men and women (aged 18 to 50 years) with the first episode of ON in the study eye, associated with unilateral visual loss. * Onset of visual loss symptoms in the previous 12 days before first administration of study treatment. Key Exclusion Criteria: \- Have a hist...

Countries:United States
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