Ozurdex is approved for treatment of DME patients who are pseudophakic (have an artificial lens implant), or who are considered insufficiently responsive to, or unsuitable for non-corticosteroids therapy.
Allergan chairman of the Board and chief executive officer David Pyott said through its efficient R&D investment, the company is able to continually bring forth new treatment options for physicians and their patients while delivering value to its stockholders.
"Following the positive opinion from the European Union’s Committee for Medicinal Products for Human Use just last month, we are particularly pleased that with this license extension for Ozurdex in Europe, in addition to the recent FDA approval in the United States, we are able to offer another important treatment option to help preserve vision for certain patients with DME," Pyott said.
The approval is based on data from the MEAD clinical trial program, which included two multi-center three-year sham-controlled, masked, randomized clinical studies evaluating the proportion of patients with 15 or more letters improvement in best-corrected visual acuity (BCVA) from baseline.
In the MEAD program, the company has evaluated the safety and efficacy of Ozurdex in the management of patients with DME.
Ozurdex, developed for the treatment of retinal disease, uses the new Novadur solid polymer delivery system that releases medicine over an extended period of time to suppress inflammation.
In the EU, the drug is already available as a treatment licensed for macular edema in patients with retinal vein occlusion (RVO) and for inflammation of the posterior segment of the eye characterized as non-infectious uveitis.