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Yutiq

Phase 3

Uveitis | Small molecule | Ophthalmology |ANI Pharmaceuticals, Inc.|Last Updated: Aug 11, 2025

Target and mechanism

ModalitySmall molecule

Also known as Yutiq Drug

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindSHAM_CONTROLLEDBiomarker
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

Yutiq · 1 trial · 4 indications

Phase 3 1
NCT05486468The Use of Two YUTIQ Versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior SegmentUveitis
RECRUITING30 Analytics
PHASE3RECRUITING
The Use of Two YUTIQ Versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment
UveitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Recurrence rate of uveitis will be assessed at the 6-month visit
6 months

The primary endpoint of recurrence rate of uveitis will be assessed at the 6-month visit. The clinical definition of intraocular inflammation recurrence is (1) a 2-step or more increase in number of cells in the anterior chamber per high-powered field (x1.6 using a 1-mm beam), (2) a 2-step or more increase in vitreous haze, or (3) a deterioration in BCVA of 15 letters or more. In each case, the etiology of the change must be only due to noninfectious uveitis.

Secondary Endpoints

Recurrence rate of uveitis at the 12-month visit
12 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment ArmEXPERIMENTALThis group will receive two YUTIQ implants at day 1.
Control ArmSHAM_COMPARATORThis group will receive two sham injections at day 1.

Interventions

NameTypeDescription
Yutiq 0.18 MG Drug ImplantDRUGYUTIQ ® (fluocinolone acetonide intravitreal implant) 0.18 mg, for intravitreal injection
Sham InjectionOTHERSham injection
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: General Inclusion Criteria: 1. Male or non-pregnant female in good general health at least 18 years of age, understands the language of the informed consent, and is willing and able to provide written informed consent and sign/date a health information release (HIPAA form) befo...

Countries:United States
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Competitive Landscape -Uveitis 5 trials