Ozurdex
Ozurdex™ (dexamethasone intravitreal implant)(J7312) is indicated for the treatment of macular edema following branch retinal vein occlusion (BRVO), central retinal vein occlusion (CRVO), or for the treatment of non-infectious uveitis affecting the posterior segment of the eye.

Ozurdex dexamethasone intravitreal implant employs the Novadur™ solid polymer drug delivery system. Ozurdex implant is injectable and biodegradable. Each implant comes preloaded in a specially designed, single-use applicator. 

The use of Ozurdex for any other indication is considered experimental/investigational, and therefore, would not be covered. A participating, preferred, or network provider can bill the member for the non-covered service.

Ozurdex is not covered under the prescription drug benefit.

Date Last Reviewed: 11/2009

Retisert
Retisert® (fluocinolone acetonide intravitreal implant)(J7311) is indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye.

Retisert is surgically 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 from Retisert as evidenced by recurrence of uveitis, Retisert may be replaced.

The use of fluocinolone acetonide for any indication other than chronic non-infectious uveitis affecting the posterior segment of the eye is considered experimental/investigational, and therefore, not covered. A participating, preferred, or network provider can bill the member for the non-covered service.

Retisert is not covered under the prescription drug benefit.

Date Last Reviewed: 06/2008

Description

Ozurdex
Ozurdex is an intravitreal implant containing 0.7 mg dexamethasone in the Novadur solid polymer drug delivery system. Ozurdex is preloaded into a single-use, specially designed applicator to facilitate injection of the rod-shaped implant directly into the vitreous.

Dexamethasone, a potent corticosteroid, has been shown to suppress inflammation by inhibiting multiple inflammatory cytokines resulting in decreased edema, fibrin deposition, capillary leakage and migration of inflammatory cells.

Retisert
Retisert is an intravitreal implant containing 0.59 mg fluocinolone acetonide in a sterile implant designed to release fluocinolone acetonide locally to the posterior segment of the eye.

A branch retinal vein occlusion is essentially a blockage of the portion of the circulation that drains the retina of blood. Central retinal vein occlusion is closure of the final retinal vein (located at the optic nerve) which collects all of the blood after it passes through the capillaries.

When the distribution of the vein involves the center of the retina (macula), bleeding and fluid leakage occur, producing symptoms. Leakage in the macula causes macular edema in which a patient will have blurred vision and loss of portions of the field of vision (corresponding to the distribution of the obstructed vein). 

Non-infectious uveitis affecting the posterior segment of the eye encompasses a heterogeneous group of inflammatory diseases, many of which are idiopathic and/or systemic in origin. Based on anatomical classification, posterior segment uveitis involves inflammation of various structures of the uvea and includes intermediate uveitis, posterior uveitis, and panuveitis. The disease is characterized by chronic inflammation, ultimately leading to cellular and structural dysfunction and eventual vision loss. Due to the aggressive and invasive nature of the disease, it is associated with a high incidence of complications which contribute to overall visual morbidity. The main cause of visual impairment in uveitis affecting the posterior segment is the ultimate development of cystoid macular edema, cataracts, or a combination thereof. Of particular importance is the fact that visual morbidity does not result from a single episode of uveitis, but rather recurrent episodes of inflammation cause cumulative damage. Poor visual outcomes are significantly associated with duration of inflammation and recurrent episodes of inflammation. Therefore, inflammation must be controlled long term if patients are going to be spared visual impairment or blindness.

The goals of therapy are to reduce inflammation, prevent damage to ocular structures, and prevent long-term visual loss. Corticosteroids have been the mainstay of treatment for posterior segment uveitis and are commonly administered systemically, or as periocular injections. Topical administration is seldom used to treat this form of disease as therapeutic drug levels do not reach the posterior segment of the eye. Periocular corticosteroid injections, which typically consist of triamcinolone acetonide, often need to be repeated at 2 to 4 month intervals in order to maintain adequate control. Complications of this form of treatment include globe perforation, orbital fibrosis, and ptosis.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Under the Federal Employee Program, all services that utilize FDA-approved drugs, devices, or biological products are eligible when intended for the treatment of a serious or life-threatening condition and when medically necessary and appropriate for the patient’s condition.

Bausch & Lomb, Inc., Retisert^TM (fluocinolone acetonide intravitreal implant) package insert, Bausch & Lomb, Inc., Rochester, NY

Long-Term Follow-up Results of a Pilot Trial of a Fluocinolone Acetonide Implant to Treat Posterior Uveitis, Ophthalmology, Vol. 112, No. 7, 2005

Fluocinolone Acetonide Implant (Retisert) for Noninfectious Posterior Uveitis: Thirty-Four-Week Results of a Multicenter Randomized Clinical Study, Ophthalmology, Vol. 113, No. 6, 06/2006

Management of Diabetic Retinopathy: A Systematic Review, JAMA, Vol. 298, No. 8, 2007

Reimplantation of a Fluocinolone Acetonide Sustained Drug Delivery Implant for Chronic Uveitis, American Journal of Ophthalmology, Vol. 145, 2008

Fluocinolone Acetonide Sustained Drug Delivery Device for Chronic Central Retinal Vein Occlusion: 12-Month Results, American Journal of Ophthalmology, 06/2008

Ozurdex™ [package insert]. Irvine, CA: Allergan, Inc; 09/2010. 

Haller JA, Bandello F, Belfort R, et al. Randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with macular edema due to retinal vein occlusion. Ophthalmology. 2010;117:1134-1146.