Retisert (Fluocinolone Acetonide Intravitreal Implant) Drug Information: Side Effects and Drug Interactions

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May 27, 2012

Retisert

Uveitis »

Introduction

Uveitis (pronounced you-vee-EYE-tis) is basically an inflammation of the eye. The condition involves all inflammatory processes of the middle layers of the eye, also called the uveal tract or uvea. The uvea includes the iris (colored part of the eye), choroid (a thin membrane containing many blood vessels) and ciliary body (the part of the eye that joins these together).

The uvea is very important because its many veins and arteries transport blood to the parts of the eye that are critical for vision.

Learn more about the structures that make up the eye in the article titled " The Amazing Human Eye ."

What Are the Symptoms of Uveitis?

Symptoms of uveitis may include:

Eye redness and irritation
Blurred vision
Eye pain
Increased sensitivity to light ...

Read the Uveitis article »

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Retisert

Eye Diseases and Conditions Slideshow Pictures

Pink Eye Slideshow Pictures

Cataracts Slideshow Pictures

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SIDE EFFECTS

Clinical Trials Experience - Ocular Events

The available safety data includes exposure to RETISERT in patients with chronic non-infectious uveitis affecting the posterior segment in two multicenter controlled clinical trials. Patients were randomized to dosage regimens of 0.59 mg or 2.1 mg implants.

The most frequently reported ocular adverse events were cataract, increased intraocular pressure, procedural complication, and eye pain. These events occurred in approximately 50 - 90% of patients. Cataract includes aggravated cataract, and posterior capsular opacification. Procedural complications includes post-op complication, post-op wound complication, post-op wound site erythema, and wound dehiscense.

Based on clinical trials with RETISERT, during the 3-year post-implantation period, nearly all phakic eyes are expected to develop cataracts and require cataract surgery. IOP lowering medications to lower intraocular pressure were required in approximately 77% of patients; filtering surgeries were required to control intraocular pressure in 37% of patients. Ocular adverse events occurring in approximately 10 - 40% of patients in decreasing order of incidence were ocular/conjunctival hyperemia, reduced visual acuity, glaucoma, conjunctival hemorrhage, blurred vision, abnormal sensation in the eye, eye irritation, maculopathy, vitreous floaters, hypotony, pruritus, ptosis, increased tearing, vitreous hemorrhage, dry eye, eyelid edema, macula edema and visual disturbance.

Ocular adverse events occurring in approximately 5 - 9% of patients in decreasing order of incidence were eye discharge, photophobia, blepharitis, corneal edema, iris adhesions, choroidal detachment, diplopia, eye swelling, retinal detachment, photopsia, retinal hemorrhage and hyphema.

Clinical Trials Experience - Non-Ocular Events

The most frequently reported non-ocular adverse event was headache (33%). Other non-ocular adverse events occurring in approximately 5-20% of patients in decreasing order of incidence were nasopharyngitis, arthralgia, sinusitis, dizziness, pyrexia, upper respiratory tract infection, influenza, vomiting, nausea, cough, back pain, limb pain, and rash.

Last reviewed on RxList: 8/2/2011
This monograph has been modified to include the generic and brand name in many instances.