June 18, 2009
Ozurdex approved for treatment of macular edema
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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