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Ozurdex Implant Approved for DME - July 2, 2014
The U.S. Food and Drug Administration approved Ozurdex (dexamethasone intravitreal implant, Allergan) as a treatment option for diabetic macular edema in adult patients who have an artificial lens implant or who are scheduled for cataract surgery. The sustained-release biodegradable steroid implant demonstrated long-term efficacy without the need for monthly injections.
The approval is based on the “Macular Edema: Assessment of Implantable Dexamethasone in Diabetes (MEAD)” study, which assessed the proportion of patients with 15 or more letters improvement in best-corrected visual acuity from baseline. The most common adverse events in the studies included cataracts and elevated intraocular pressure. An increase in mean IOP was seen with each treatment cycle, and the mean IOP generally returned to baseline between treatment cycles.
The implant uses a proprietary solid polymer delivery system (Novadur, Allergan), a biodegradable implant that releases medicine over an extended period of time, to suppress inflammation.
Ozurdex is already indicated 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. For full prescribing information, visit http://www.allergan.com/assets/pdf/ozurdex_pi.pdf.