The FDA has approved Ozurdex (dexamethasone intravitreal implant) 0.7 mg for treatment of diabetic macular edema, according to a press release from Allergan.
In June 2014, Ozurdex was approved for treatment of adult patients with diabetic macular edema who have an artificial lens implant or are scheduled for cataract surgery. The FDA’s decision expands this indication to include the general diabetic macular edema patient population.
The implant employs the Novadur solid polymer delivery system to suppress inflammation.
The agency based its approval of the new indication for Ozurdex on data from the Macular Edema: Assessment of Implantable Dexamethasone in Diabetes (MEAD) study, which included two multicenter, 3-year, sham-controlled, randomized clinical studies.
Long-term efficacy in the treatment of diabetic macular edema without the need for monthly objections was observed with Odzurdex, with the most common adverse events being cataracts and elevated intraocular pressure, according to the release.
Ozurdex is also approved for the treatment of macular edema after branch retinal vein occlusion or central retinal vein occlusion and the treatment of noninfectious uveitis affecting the posterior segment of the eye.