Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Yutiq Drug · 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, Adalimumab |
| ANI Pharmaceuticals, Inc. | ANIP | 1 | PHASE3 | Yutiq Drug |
| TScan Therapeutics, Inc. | TCRX | 1 | - | Undisclosed |
Yutiq is an investigational small molecule drug implant being developed for the treatment of uveitis, specifically chronic non-infectious intraocular inflammation affecting the posterior segment. It is currently in Phase 3 clinical development and has not been approved by the FDA.
Yutiq is a small molecule drug implant designed for the treatment of uveitis. The specific molecular target of Yutiq has not been disclosed in the available information, so its precise mechanism of action is not detailed here.
Yutiq is being developed by ANI Pharmaceuticals, Inc., a company traded on the NASDAQ under the ticker symbol ANIP. The drug is currently in Phase 3 clinical trials for the treatment of uveitis.
Yutiq is currently in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 3 trial is actively recruiting participants to evaluate the drug's safety and efficacy in patients with uveitis.
Yutiq is being studied in a Phase 3 clinical trial registered as NCT05486468. This randomized, double-blind, sham-controlled trial is evaluating the use of two Yutiq implants versus sham treatment for chronic non-infectious intraocular inflammation affecting the posterior segment. The trial is recruiting 30 participants in the United States.
Yes, Yutiq is also known as Yutiq 0.18 MG Drug Implant. Both names refer to the same investigational drug product being developed by ANI Pharmaceuticals for the treatment of uveitis.