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AKB-9778 4%

Phase 2

Ocular Hypertension | Small molecule | Ophthalmology |EyePoint, Inc.|Last Updated: May 25, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment194

FDA Designations

No designations recorded

Clinical trial landscape

AKB-9778 4% · 1 trial · 2 indications

Phase 2 1
NCT04405245Study to Assess the Efficacy, Safety and Tolerability of AKB-9778 Ophthalmic Solution as and Adjunct to Latanoprost in Patients With Ocular Hypertension or Open Angle GlaucomaOcular Hypertension
COMPLETED194 Analytics
PHASE2COMPLETED
Study to Assess the Efficacy, Safety and Tolerability of AKB-9778 Ophthalmic Solution as and Adjunct to Latanoprost in Patients With Ocular Hypertension or Open Angle Glaucoma
Ocular HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Intraocular Pressure at Day 28 (Study Eye)
Baseline to Day 28

Change from Baseline in Diurnal Mean IOP (mmHg) at Day 28 in the Study Eye -- ITT Population

Secondary Endpoints

Mean Change From Baseline in Diurnal Mean IOP at the Day 14 Visit (Study Eye)
Baseline to Day 14
Mean Change From Baseline in Diurnal Mean IOP on Days 14 and 28 (Both Eyes)
Baseline to Day 14 and Baseline to Day 28
Observed Mean Diurnal Mean IOP on Days 14 and 28 (Both Eyes)
Baseline to Day 14 and Baseline to Day 28
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AKB-9778 4% QD + LatanoprostEXPERIMENTAL• AKB-9778 4% daily (AM) and placebo for ophthalmic solution daily (PM) plus latanoprost daily (PM) for 28 days
AKB-9778 4% BID + LatanoprostEXPERIMENTAL• AKB-9778 4% twice daily (AM \& PM) plus latanoprost daily (PM) for 28 days
Placebo Twice Daily + LatanoprostPLACEBO_COMPARATOR• Placebo for AKB-9778 4% ophthalmic solution twice daily (AM \& PM) plus latanoprost daily (PM) for 28 days

Interventions

NameTypeDescription
Latanoprost ophthalmic solutionDRUGLatanoprost opthalmic solution to be dosed once daily
AKB-9778 4%DRUGRazuprotafib opthalmic solution
PlaceboDRUGplacebo for razuprotafib opthalmic solution
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites21

Key Inclusion Criteria: * Diagnosis of OAG or OHT in each eye (OAG in one eye and OHT in the fellow eye is acceptable) * Must be receiving treatment with a stable regimen of topical prostaglandin eyedrop for a minimum of 2 weeks prior to the Screening Visit; may be taking one additional IOP lowerin...

Countries:United States
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Competitive Landscape -Ocular Hypertension 7 trials