Fluocinolone Acetonide Intravitreal Implant 0.18 mg in the Treatment of Chronic Non-Infectious Posterior Segment Uveitis

Inclusion Criteria:

• Male or female in good general health at least 18 years of age at time of consent.

• Presence of active, recurrent, unilateral or bilateral non-infectious uveitisaffecting the posterior segment (intraocular inflammation) with a duration of atleast 3 months from initial diagnosis, as determined by the Investigator.Intermediate or panuveitis will also be allowed if posterior segment involvement ispart of the diagnosis.

• Posterior segment inflammation that has previously demonstrated a clinical responseto ≥1 localized corticosteroid treatment (eg, topical steroid 2 to 4 times per dayor intra- or peri-ocular injection).

• Presence of macular edema as measured by spectral-domain - optical coherencetomography (SD-OCT) (≥325 microns on Heidelberg SPECTRALIS and ≥315 microns on ZeissCIRRUS).

• Best corrected visual acuity (BCVA) of the study eye 35-75 letters on the ETDRSchart (Snellen range 20/30 to 20/200).

• Not planning to undergo elective ocular surgery during the study.

• Able to understand, sign the Informed Consent Form (ICF).

• Willingness and ability to comply with scheduled visits, treatment plan, laboratorytests, and other study procedures.

Exclusion Criteria:

• History of macular edema due to diabetes, retinal vein occlusion (RVO), age-relatedmacular degeneration (AMD), or any non-inflammatory cause.

• Intraocular inflammation with infectious etiology.

• Diagnosis of uncontrolled glaucoma or ocular hypertension at Screening, unless studyeye is being treated with ≤2 intraocular pressure (IOP)-lowering medications and/orhas been previously treated with an incisional surgical procedure OR glaucoma laserprocedure resulting in stable IOP in the normal range (10 to 21 mmHg).

• Intraocular pressure >21 mmHg or concurrent therapy at Screening with >2IOP-lowering pharmacologic agents in the study eye.

• Ocular malignancy in either eye, including choroidal melanoma.

• Previous viral retinitis.

• Toxoplasmosis scar or scar related to previous viral retinitis in the study eye.

• Ocular and periocular infections such as diseases of the cornea and conjunctivaincluding epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, andvaricella, mycobacterial infections of the eye, or fungal diseases of ocularstructures.

• Hypersensitivity to any of the ingredients contained in YUTIQ®.

• Media opacity precluding evaluation of retina and vitreous (eg, vitreoushemorrhage).

• Any current retinal detachment or retinoschisis in insertion in the study eye.

• Chronic hypotony, defined as <6 mmHg for at least 1 month's duration, and documentedon at least two separate visits.

• Ocular surgery within 12 weeks prior to Day 1.

• YAG laser capsulotomy within 30 days prior to Day 1.

• Prior intravitreal treatment with Retisert®, ILUVIEN®, or YUTIQ® (0.18 mg) within 36months prior to Day 1.

• Prior intravitreal treatment with OZURDEX® within 12 weeks prior to Day 1.

• Prior intravitreal treatment with Triesence® or TRIVARIS™ (triamcinolone) within 12weeks prior to Day 1.

• Peri-ocular or subtenon steroid treatment within 12 weeks prior to Day 1.

• Radiation to the head or neck within 2 years prior to Screening.

• Steroid allergy, particularly to fluocinolone.

• Any systemic condition that requires chronic systemic anti-inflammatory, steroid, orimmunosuppressive therapy (subjects on a stable dose of oral prednisone <7.5 mg perday for a non-ocular indication may be included).

• Positive test for human immunodeficiency virus (HIV), tuberculosis, or syphilis inthe past 2 years or during Screening.

• Any severe acute or chronic medical (eg, cancer diagnosis) or psychiatric conditionthat could increase the risk associated with study participation or could interferewith the interpretation of study results and make the subject inappropriate forstudy enrollment.

• Any other systemic or ocular condition which, in the judgment of the Investigator,could make the subject inappropriate for study enrollment.

• Treatment with an investigational drug or device within 30 days prior to Day 1.

• Pregnant or nursing females; females of childbearing potential who are unwilling orunable to use an acceptable method of contraception as outlined in the protocol fromat least 14 days prior to Day 1 until the final study visit.