Allergan receives FDA approval for Ozurdex for use in certain DME patients

July 8, 2014

Allergan recently announced it has received U.S. Food and Drug Administration (FDA) approval for Ozurdex (dexamethasone intravitreal implant) 0.7 mg as a new treatment option for diabetic macular edema (DME) in adult patients who have an artificial lens implant (pseudophakic) or are scheduled for cataract surgery (phakic).

Irvine, CA-Allergan recently announced it has received U.S. Food and Drug Administration (FDA) approval for Ozurdex (dexamethasone intravitreal implant) 0.7 mg as a new treatment option for diabetic macular edema (DME) in adult patients who have an artificial lens implant (pseudophakic) or are scheduled for cataract surgery (phakic). 

Ozurdex is a sustained-release, biodegradable steroid implant that demonstrated long-term efficacy without the need for monthly injections. The implant uses the Novadur solid polymer delivery system, 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.

The latest FDA approval for Ozurdex is based on the Macular Edema: Assessment of Implantable Dexamethasone in Diabebetes (MEAD) study, which includes two multi-center, 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 most common adverse events during the MEAD studies included cataracts and elevated intraocular pressure (IOP). An increase in mean IOP was seen with each treatment cycle, but the mean IOP generally returned to baseline between treatment cycles.