The CHMP recommendation of OZURDEX (dexamethasone 700mcg intravitreal implant in applicator) is for DME patients who are pseudophakic (have an artificial lens implant), or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy.
The final decision for marketing authorization of OZURDEX from the European Commission is expected within a few months.
Allergan chairman of the Board and chief executive officer David Pyott said with a commitment to the development of new treatment options that address unmet patient needs, the company is happy with the CHMP’s recommendation to expand the license for OZURDEX, an important tool in the armamentarium of the European retinal specialist, as evidenced by the fact that OZURDEX sales are currently more than twice those of the US.
"Allergan is widely recognized for having one of the most productive R&D pipelines in the industry and secured a record 180-plus approvals for products and indications around the world last year," Pyott said.
"Our ability to advance R&D programs allows us to continually bring forth new treatment options for physicians and their patients while delivering value to our stockholders."
Allergan Research and Development executive vice-president and chief scientific officer Scott Whitcup said OZURDEX is a leading treatment for macular edema in patients with retinal vein occlusion and uveitis in Europe, and is approved for multiple indications in the US including most recently for use in certain patients with diabetic macular edema.
"DME is a complicated disease to treat, and the additional license for OZURDEX in the EU would offer another important treatment option to help preserve vision for patients," Whitcup said.
OZURDEX is already available throughout the EU 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.