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Label indication 1. INDICATIONS AND USAGE YUTIQ ® (fluocinolone acetonide intravitreal implant) 0.18 mg is indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. YUTIQ contains a corticosteroid and is indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. ( 1 )
Also known as Yutiq Drug
Yutiq · 1 trial · 4 indications
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.
| Arm | Type | Description |
|---|---|---|
| Treatment Arm | EXPERIMENTAL | This group will receive two YUTIQ implants at day 1. |
| Control Arm | SHAM_COMPARATOR | This group will receive two sham injections at day 1. |
| Name | Type | Description |
|---|---|---|
| Yutiq 0.18 MG Drug Implant | DRUG | YUTIQ ® (fluocinolone acetonide intravitreal implant) 0.18 mg, for intravitreal injection |
| Sham Injection | OTHER | Sham injection |
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Roivant Sciences Ltd. | ROIV | 1 | PHASE3 | Brepocitinib |
| Eli Lilly and Company | LLY | 1 | PHASE3 | Baricitinib |
| ANI Pharmaceuticals, Inc. | ANIP | 1 | PHASE3 | Yutiq |
Yutiq is used to treat uveitis, a group of inflammatory eye conditions affecting the posterior segment of the eye. It is being studied for chronic non-infectious intraocular inflammation, including posterior, anterior, and intermediate uveitis. Yutiq is an ophthalmology therapy delivered as a drug implant.
Yutiq is developed by ANI Pharmaceuticals, Inc., which trades under the ticker ANIP. The company is responsible for the clinical development of the Yutiq drug implant for uveitis.
Yutiq is in Phase 3 clinical development for uveitis. It is an investigational therapy and has not been approved by the FDA. The ongoing Phase 3 trial is currently recruiting participants.
Yutiq is being evaluated in one Phase 3 clinical trial, NCT05486468, titled "The Use of Two YUTIQ Versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment." The trial is recruiting in the United States, with an estimated enrollment of 30 participants.