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FAI Insert administered using the Mk II inserter · 1 trial · 1 indication
The primary utilization endpoint was defined as the proportion of intravitreal insertion procedures that were assessed by the investigator as satisfactory. A satisfactory procedure was defined as one receiving a score from the Investigator as either Very Easy, Easy, or Routine.
| Arm | Type | Description |
|---|---|---|
| FAI Insert administered using the Mk II inserter | EXPERIMENTAL | The test article is the Fluocinolone Acetonide Intravitreal (FAI) insert, which contains 0.18 mg FA and delivers FA into the vitreous humor for 36 months, at a nominal rate of approximately 0.2 μg FA/day. The FAI insert will be administered to the study eye as an intravitreal injection through the pars plana. |
| FAI Insert administered using the Mk I inserter | ACTIVE_COMPARATOR | The test article is the Fluocinolone Acetonide Intravitreal (FAI) insert, which contains 0.18 mg FA and delivers FA into the vitreous humor for 36 months, at a nominal rate of approximately 0.2 μg FA/day. The FAI insert will be administered to the study eye as an intravitreal injection through the pars plana. |
| Name | Type | Description |
|---|---|---|
| FAI Insert administered using the Mk II inserter | DRUG | - |
| FAI Insert administered using the Mk I inserter | DRUG | - |
Inclusion Criteria: 1. Male or non-pregnant female at least 18 years of age at time of consent 2. At least one eye has a history of non-infectious uveitis affecting the posterior segment 3. Subject has ability to understand and sign the Informed Consent Form 4. Subject is willing and able to comply...
FAI Insert administered using the Mk II inserter is an investigational small molecule being developed for the treatment of non-infectious uveitis, a form of eye inflammation. It is delivered via a specialized inserter device and is currently in Phase 3 clinical development.
FAI Insert administered using the Mk II inserter is being developed by EyePoint, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol EYPT. The company is conducting clinical trials to evaluate the safety and utilization of this treatment for non-infectious uveitis.
FAI Insert administered using the Mk II inserter is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and efficacy for non-infectious uveitis.
FAI Insert administered using the Mk II inserter has one completed Phase 3 clinical trial, identified as NCT02748512. This trial, titled 'Utilization and Safety of the Mk II Inserter and the Safety of the FAI Insert in Non-Infectious Uveitis,' enrolled 26 participants in the United States and was active-controlled.
The drug is referred to as FAI Insert, which stands for fluocinolone acetonide intravitreal insert. It is administered using the Mk II inserter device. The trial NCT02748512 evaluated the safety of this insert in patients with non-infectious uveitis.