FDA approves Ozurdex for treatment of certain patients with DME

The U.S. Food and Drug Administration has approved Ozurdex for the treatment of diabetic macular edema in certain patients, Allergan announced in a press release.

The sustained-release, biodegradable dexamethasone intravitreal implant (Ozurdex, Allergan) 0.7 mg is indicated for adult patients with DME who have artificial lens implants or are scheduled for cataract surgery. The approval is based on the MEAD trial, which included two multicenter, 3-year, sham-controlled, masked, randomized clinical studies of patients with 15 or more letters improvement in best corrected visual acuity from baseline, according to the press release.

“DME is a complicated disease to treat,” Pravin Dugel, MD, a clinical associate professor of ophthalmology at the Keck School of Medicine and a clinical investigator in the MEAD trial, said in the press release. “Ozurdex provides long-term improvement of DME without the need for monthly injections, which helps these patients who are also managing the other conditions common with diabetes.”

Common adverse events included cataracts and elevated IOP.

The implant is already indicated for the treatment of macular edema following branch retinal vein occlusion and central retinal vein occlusion, as well as for the treatment of noninfectious uveitis, according to the press release.