Retisert (fluocinolone acetonide intravitreal implant)

Retisert is indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. It is a corticosteroid used to treat inflammation within the eye that may be caused by a variety of diseases or infections. 

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.

Dosing Information

• Retisert (fluocinolone acetonide intravitreal implant) 0.59 mg is implanted into the posterior segment of the affected eye through a pars plana incision.
• The implant contains one tablet of 0.59 mg of fluocinolone acetonide.
• Retisert is designed to release fluocinolone acetonide at a nominal initial rate of 0.6 μg/day, decreasing over the first month to a steady state between 0.3-0.4 μg/day over approximately 30 months.
• Following depletion of fluocinolone acetonide as evidenced by recurrence of uveitis, Retisert may be replaced.

Handling of Implant

• Caution should be exercised in handling Retisert in order to avoid damage to the implant, which may result in an increased rate of drug release from the implant.
• Thus, Retisert should be handled only by the suture tab.
• Care should be taken during implantation and explantation to avoid sheer forces on the implant that could disengage the silicone cup reservoir (which contains a fluocinolone acetonide tablet) from the suture tab.
• Aseptic technique should be maintained at all times prior to and during the surgical implantation procedure.
• Retisert should not be resterilized by any method.

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• No adequate animal reproduction studies have been conducted with fluocinolone acetonide.
• There are no adequate and well-controlled studies in pregnant women.
• Retisert should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
• It is not known whether ocular administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk.
• Systemic steroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects.
• Caution should be exercised when Retisert is implanted in a nursing woman.