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KIO-104

Phase 2

Macular Edema | Small molecule | Ophthalmology |Kiora Pharmaceuticals, Inc.|Last Updated: Jun 16, 2026

Success Probability
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Market & Valuation
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Trial Design
CONTROLLED
Total Trials1
Total Enrollment28
FDA Designations
No designations recorded
Clinical trial landscape

KIO-104 · 1 trial · 1 indication

Phase 2 1
NCT06825702Safety, Tolerability and Efficacy of Intravitreal KIO-104 in Patients With Macular EdemaMacular Edema
RECRUITING28 Analytics
PHASE2RECRUITING
Safety, Tolerability and Efficacy of Intravitreal KIO-104 in Patients With Macular Edema
Macular EdemaUnlock trial analytics
Study Endpoints
Primary Endpoints
Safety and Tolerability
23months

The primary objective is safety and tolerability. The incidence of AEs will be presented by System Organ Class (SOC) and Preferred Term (PT) by dose cohorts.

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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Low Dose KIO-104: 2-weeklyEXPERIMENTAL2-weekly dosing
High Dose KIO-104: 2-weeklyEXPERIMENTAL2-weekly dosing
Low or High Dose KIO-104: 2-weeklyEXPERIMENTAL2-weekly dosing
Low or High Dose KIO-104: 4-weeklyEXPERIMENTAL4-weekly dosing
Interventions
NameTypeDescription
KIO-104DRUGKIO-104 is an ophthalmic formulation for IVT injection of the active pharmaceutical ingredient (API) KIO-100, a novel, non-steroidal, small molecule inhibitor of dihydroorotate dehydrogenase (DHODH).
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Eligibility Criteria
Age Range18 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: Participants must meet all the following criteria: 1. Be aged 18 to 85 years inclusive at the time of consent. 2. Provide informed consent prior to any study procedures, as stipulated by local laws, Ethics Committee (EC) and Regulatory Authority (RA) guidelines. 3. Be willing a...

Countries:Australia
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Recent Changes (Last 90 Days)
LOWJun 16, 2026NCT06825702lastUpdatePostDate: changed
LOWJun 16, 2026NCT06825702lastUpdatePostDate: changed
LOWJun 16, 2026NCT06825702lastUpdatePostDate: changed
LOWMay 26, 2026NCT06825702primaryCompletionDate: changed
LOWMay 24, 2026NCT06825702studyFirstPostDate: changed