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FDA approves expanded indication for Ozurdex implant

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The U.S. Food and Drug Administration has approved Ozurdex for the general patient population being treated for diabetic macular edema, Allergan announced in a press release.

In June, the FDA approved Ozurdex (dexamethasone intravitreal implant 0.7 mg) for the treatment of DME in pseudophakic adult patients or patients who were scheduled for cataract surgery.

The FDA’s initial approval of Ozurdex was based on results from the MEAD study, which comprised two multi-center, sham-controlled, randomized clinical studies. The primary outcome measure was the proportion of patients who had a 15-letter or greater improvement in best corrected visual acuity.

The most common adverse events related to treatment were cataracts and elevated IOP. In most cases, IOP returned to baseline values between treatment cycles, according to the release.

Ozurdex is also indicated for the treatment of macular edema secondary to branch retinal vein occlusion and central retinal vein occlusion, as well as for the treatment of non-infectious uveitis in the posterior segment of the eye.