Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Fluocinolone Acetonide, Active Drug
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 therapy being developed by EyePoint, Inc. for non-infectious uveitis and posterior uveitis. It is designed as an intravitreal insert containing fluocinolone acetonide, a corticosteroid, intended to deliver sustained drug release inside the eye. It is currently in Phase 3 clinical development.
FAI Insert is being studied for the treatment of non-infectious uveitis, including posterior uveitis, intermediate uveitis, and panuveitis. These are inflammatory eye conditions not caused by infection. The goal of treatment is to reduce intraocular inflammation. FAI Insert remains investigational and has not been approved for any indication.
FAI Insert is being developed by EyePoint, Inc., which trades under the ticker EYPT. EyePoint is a biopharmaceutical company focused on ophthalmology therapies. The company is advancing FAI Insert through Phase 3 clinical development for non-infectious uveitis and posterior uveitis.
FAI Insert is in Phase 3 clinical development. Two Phase 3 trials have been completed: NCT02746991 and NCT01694186. The drug is investigational and has not been approved by the FDA or any other regulatory agency for any indication.
FAI Insert has been evaluated in two completed Phase 3 trials. NCT02746991 studied a FAI insert in subjects with chronic non-infectious posterior uveitis in India with 153 participants. NCT01694186 studied an injectable fluocinolone acetonide intravitreal insert in non-infectious uveitis across the United States, Germany, Hungary, India, Israel, and the United Kingdom with 129 participants.