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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

| General Information | Clinical Results | Side Effects | Mechanism of Action | Literature References | Additional Information |


General Information

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.


Clinical Results

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.


    Side Effects

    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


    Mechanism of Action

    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.


    Literature References

    Haller JA, Dugel P, Weinberg DV, Chou C, Whitcup SM Evaluation of the safety and performance of an applicator for a novel intravitreal dexamethasone drug delivery system for the treatment of macular edema. Retina 2009 Jan;29(1):46-51

    Fialho SL, Behar-Cohen F, Silva-Cunha A Dexamethasone-loaded poly(epsilon-caprolactone) intravitreal implants: a pilot study. European Journal of Pharmaceutics and Biopharmaceutics 2008 Mar;68(3):637-46

    Kuppermann BD, Blumenkranz MS, Haller JA, Williams GA, Weinberg DV, Chou C, Whitcup SM; Dexamethasone DDS Phase II Study Group Randomized controlled study of an intravitreous dexamethasone drug delivery system in patients with persistent macular edema. Archives of Ophthalmology 2007 Mar;125(3):309-17

    Fialho SL, Rêgo MB, Siqueira RC, Jorge R, Haddad A, Rodrigues AL, Maia-Filho A, Silva-Cunha A Safety and pharmacokinetics of an intravitreal biodegradable implant of dexamethasone acetate in rabbit eyes. Current Eye Research 2006 Jun;31(6):525-34


    Additional Information

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


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    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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