Allergan’s Ozurdex (dexamethasone intravitreal implant) has been approved by the FDA for the treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO). Ozurdex is a biodegradable implant administered by intravitreal injection that delivers dexamethasone via Allergan’s proprietary NOVADUR solid polymer delivery system, which enables the extended release and effects of dexamethasone. The implant is placed in the vitreous cavity in the back of the eye to treat the macular edema associated with RVO, thereby improving visual acuity.
This approval was based on data from two multi-center, double-masked, randomized, parallel studies involving approximately 1,300 patients. In each study, and in a pooled analysis, time to achieve a ≥15 letter (3-line) improvement in best-corrected visual acuity cumulative response rate curves were significantly faster with Ozurdex treated patients compared to sham-treated patients. The onset of effect with Ozurdex occurred within the first two months after implantation in approximately 20–30% of patients. The duration of effect persisted approximately 1–3 months after onset.
Ozurdex is administered as an in-office procedure and is expected to be available in the third quarter of 2009.
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