Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal Insert (FAI)

This is an interventional treatment trial for Uveitis focused on measuring EYP-2102, EyePoint, Uveitis Read More

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 (intermediate, posterior, or panuveitis) with or without anterior uveitis > 1 year duration.
• During the 52 weeks prior to enrollment (Day 1), the study eye has either received treatment systemic corticosteroid or other systemic therapies given for at least 12 weeks, and/or at least 2 intra- or peri-ocular injections of corticosteroid for management of uveitis OR the study eye has experienced recurrence recurrences of uveitis at least 2 separate times requiring systemic, intra- or peri-ocular injection of corticosteroid.
• Subject is not planning to undergo elective ocular surgery during the study
• Subject has ability to understand and sign the Informed Consent Form (ICF).
• Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• History of posterior uveitis only that is not accompanied by vitritis or macular edema.
• History of iritis only associated with no vitreous cells, anterior chamber cells, or vitreous haze at Day 1.
• Uveitis with infectious etiology.
• Vitreous hemorrhage.
• Intraocular inflammation associated with a condition other than noninfectious uveitis (eg, intraocular lymphoma).
• Uveitis limited to the anterior segment, ie, anterior uveitis only.
• Ocular malignancy in either eye, including choroidal melanoma.
• Previous viral retinitis.
• Requirement for chronic systemic or inhaled corticosteroid therapy (>15mg prednisone daily) or chronic systemic immunosuppressive therapy.
• History of certain skin cancers (specifically, basal cell carcinoma and squamous cell carcinoma), any malignancy receiving treatment, or in remission less than 5 years prior to Day 1.
• Positive test for human immunodeficiency virus (HIV) or syphilis during Screening.
• Mycobacterial uveitis or chorioretinal changes of either eye which, in the opinion of the Investigator, result from infectious mycobacterial uveitis.
• Systemic infection within 30 days prior to Day 1.
• Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in the protocol from at least 14 days prior to Day 1 until the 52-week Visit.
• Other protocol-specified exclusion criteria may apply.