Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FAI Insert · 2 trials · 4 indications
Proportion of Subjects with Recurrence of Uveitis in the Study Eye within 6 Months Including Reason for Imputed Recurrence (ITT Population)
Safety: Ocular adverse events, including IOP elevation; medications/procedures required to control elevated IOP; development or worsening of cataract; cataract-related procedures; clinically significant ocular changes; procedure related adverse events Primary Efficacy Endpoint: Proportion of subjects who have a recurrence of uveitis in the study eye within 6 months after receiving study treatment.
| Arm | Type | Description |
|---|---|---|
| Sham Injection | SHAM_COMPARATOR | Sham Injection |
| FAI Insert | EXPERIMENTAL | FAI Insert (0.18 mg fluocinolone acetonide) |
| Name | Type | Description |
|---|---|---|
| Sham Injection | DRUG | Placebo |
| FAI Insert | DRUG | Fluocinolone Acetonide |
Inclusion Criteria: * Male or non pregnant female at least 18 years of age at time of consent * One or both eyes having a history of recurrent non-infectious uveitis affecting the posterior segment of the eye with or without anterior uveitis \> 1 year duration * At the time of enrollment (Day 1), s...
FAI Insert is an investigational small molecule being developed by EyePoint, Inc. for the treatment of non-infectious uveitis affecting the posterior segment of the eye, including posterior uveitis, intermediate uveitis, and panuveitis. It is designed as an intravitreal insert for sustained delivery of the corticosteroid fluocinolone acetonide.
FAI Insert contains fluocinolone acetonide, a corticosteroid that works by suppressing inflammation in the eye. It is administered as an intravitreal insert to provide sustained local delivery of the drug to the posterior segment, targeting inflammatory pathways involved in non-infectious uveitis.
FAI Insert is being developed by EyePoint, Inc., a biopharmaceutical company focused on ophthalmology. The company's stock is traded under the ticker symbol EYPT.
FAI Insert is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 3 trials have been completed, evaluating its safety and efficacy in patients with non-infectious uveitis.
FAI Insert has been studied in two completed Phase 3 trials. NCT01694186 enrolled 129 patients with non-infectious uveitis across the United States, Germany, Hungary, India, Israel, and the United Kingdom. NCT02746991 enrolled 153 patients with chronic non-infectious posterior uveitis, intermediate uveitis, or panuveitis in India.
FAI Insert is an injectable fluocinolone acetonide intravitreal insert. The clinical trials refer to it as an injectable fluocinolone acetonide intravitreal insert, and FAI is an abbreviation for fluocinolone acetonide insert. It is a specific formulation developed by EyePoint, Inc.