for people ages 18 years and up (full criteria)
at Waltham, Massachusetts
study started



A study to evaluate the safety and efficacy of an FAI insert for the management of subjects with non-infectious uveitis affecting the posterior segment of the eye.

Official Title

A Phase 3, Multicenter, Prospective, Randomized, Masked, Controlled, Safety and Efficacy Study of a Fluocinolone Acetonide (FA) Intravitreal 0.05 mg Insert (Yutiq 0.05 mg) in Subjects With Chronic Non-Infectious Uveitis Affecting the Posterior Segment of the Eye


This is a phase 3, multi-center, randomized, masked, controlled study to evaluate the safety and efficacy of an injectable fluocinolone acetonide intravitreal (FAI) insert for the management of subjects with non-infectious uveitis affecting the posterior segment of the eye. Patients will be randomized to receive either a sham injection or the FAI insert and will be observed for one year following treatment.


Uveitis, Uveitis, Posterior, Uveitis, Intermediate, EYP-2102, EyePoint, Posterior Uveitis, Intermediate Uveitis, Pars Planitis, FAI Insert, FAI insert (0.05 mg fluocinolone acetonide)


You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.


  • EyePoint Study Site
    Waltham Massachusetts 02451 United States


accepting new patients
Start Date
Completion Date
EyePoint Pharmaceuticals, Inc.
Sign up for this study
Phase 3 research study
Study Type
About 12 people participating
Last Updated