FDA expands Ozurdex indication for DME - Allergan
Allergan, Inc., has announced that the FDA has approved Ozurdex (dexamethasone intravitreal implant) 0.7 mg, a sustained-release biodegradable steroid implant, for the treatment of Diabetic Macular Edema (DME). Ozurdex was originally approved in June 2014 as a treatment for DME in adult patients who have an artificial lens implant (pseudophakic) or who are scheduled for cataract surgery (phakic). Based on ongoing review of clinical data demonstrating efficacy and safety, the FDA has now approved Ozurdex for use in the general DME patient population.
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