Ozurdex (dexamethasone)

Company
Allergan

Approval Status
Approved June 2009

Treatment for
macular edema following branch retinal vein occlusion or central retinal vein occlusion

Areas
Eye Health / Ophthalmology

Ozurdex is an intravitreal implant containing 0.7 mg (700 µg) dexamethasone in the Novadur solid polymer drug delivery system. 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.

Ozurdex is specifically indicated for the treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).

Ozurdex is supplied as an 0.7 mg implant for intravitreal injection.

FDA Approval
The FDA approval of Ozurdex was based on the results of two, multicenter, double-masked, randomized, parallel studies. Following a single injection of Ozurdex, the following clinical results for the percent of patients with ≥ 15 letters of improvement from baseline in best-corrected visual acuity (BCVA):

Study One (n=403)

  • Day 30: 20% for the Ozurdex arm vs. 7% for placebo (p<0.01)
  • Day 60: 29% vs. 10% (p<0.01)
  • Day 90: 22% vs.(12% (p<0.01)
  • Day 180: 19% vs. 18% (p= 0.780)
  • Study Two (n=450)

  • Day 30: 23% for the Ozurdex arm vs. 8% for placebo (p<0.01)
  • Day 60: 30% vs. 12% (p<0.01)
  • Day 90: 21% vs.14% (p=0.039)
  • Day 180: 24% vs. 17% (p=0.087)
  • In each individual study and in a pooled analysis, time to achieve ≥15 letters (3-line) improvement in BCVA cumulative response rate curves were significantly faster with Ozurdex compared to sham (p< 0.01). The onset of a ≥ 15 letter (3 line) improvement in BCVA with Ozurdex occurs within the first two months after implantation in approximately 20-30% of subjects. The duration of effect persists approximately one to three months after onset of this effect.

    Adverse events associated with the use of Ozurdex may include, but are not limited to, the following:

    • Intraocular pressure increased
    • Conjunctival hemorrhage
    • Eye pain
    • Conjunctival hyperemia
    • Ocular hypertension
    • Cataract
    • Vitreous detachment
    • Headache

    Ozurdex is an intravitreal implant containing 0.7 mg (700 µg) dexamethasone in the Novadur solid polymer drug delivery system. 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.

    For additional information regarding Ozurdex or macular edema following branch retinal vein occlusion or central retinal vein occlusion, please visit the Ozurdex web page.

    Ozurdex Drug Information

    The Ozurdex drug information shown above is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.

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