Allergan announced that the Food and Drug Administration (FDA) has approved Ozurdex (dexamethasone intravitreal implant) for the treatment of diabetic macular edema (DME).

Ozurdex was initially approved as treatment for DME in patients who have an artificial lens implant or who are scheduled for cataract surgery. The new indication now allows Ozurdex for use in the general DME population. Ozurdex is also indicated for use in macular edema following branch retinal vein occlusion (BRVO) or central vein occlusion (CRVO), and for the treatment of non-infectious uveitis affecting posterior segment of the eye.

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The FDA approval was based on the MEAD (Macular Edema: Assessment of Implantable Dexamethasone in Diabetes) study, which included 2 multi-center 3-year sham-controlled, masked, randomized clinical studies. Ozurdex showed long-term efficacy in the treatment of DME without the need for monthly injections in adults with 15 or more letters improvement in best-corrected visual acuity (BCVA) from baseline.

Ozurdex is a sustained-release biodegradable steroid implant available in a 0.7mg strength.

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