General Information

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

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.

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

Dosing/Administration

Ozurdex is supplied as a 0.7-mg implant for intravitreal injection.

Clinical Trial 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 percentage of patients with ≥ 15 letters of improvement from baseline in best-corrected visual acuity (BCVA):

Study One (n=403)

·  Day 30: 20 percent for the Ozurdex arm vs. 7 percent for placebo (p<0.01)

·  Day 60: 29 percent vs. 10 percent (p<0.01)

·  Day 90: 22 percent vs.(12 percent (p<0.01)

·  Day 180: 19 percent vs. 18 percent (p= 0.780)

Study Two (n=450)

·  Day 30: 23 percent for the Ozurdex arm vs. 8 percent for placebo (p<0.01)

·  Day 60: 30 percent vs. 12 percent (p<0.01)

·  Day 90: 21 percent vs.14 percent (p=0.039)

·  Day 180: 24 percent vs. 17 percent (p=0.087)

In each individual study and in a pooled analysis, time to achieve ≥15 letters (three-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 (three-line) improvement in BCVA with Ozurdex occurs within the first two months after implantation in approximately 20 to 30 percent of subjects. The duration of effect persists approximately one to three months after onset of this effect.