FDA Grants DME Indication for Ozurdex

Allergan Logo

Allergan LogoThe FDA approved Allergan’s sustained-release dexamethasone intravitreal implant 0.7 mg (Ozurdex) as a new treatment option for diabetic macular edema in adult patients who have an artificial lens implant (pseudophakic) or who are scheduled for cataract surgery (phakic). Approval of Ozurdex for this indication is based on the MEAD (Macular Edema: Assessment of Implantable Dexamethasone in Diabetes) study. MEAD includes two multicenter, three-year, sham-controlled, masked, randomized clinical studies assessing the proportion of patients with 15 or more letters improvement in best-corrected visual acuity from baseline.

The implant had previously received FDA approval for the treatment of macular edema following branch retinal vein occlusion or central retinal vein occlusion and for the treatment of non-infectious uveitis affecting the posterior segment of the eye.

Visit www.ozurdex.com.