Allergan receives European recommendation for Ozurdex

Allergan has received a recommendation relating to its application for European approval of Ozurdex, a new macular oedema drug delivery system.

The European Medicine Agency’s Committee for Medicinal Products for Human Use has recommended granting marketing authorisation for the new implant, which is designed for sufferers of retinal vein occlusion.

It comes after the device was shown in clinical trials to effect statistically significant improvements in the vision of patients when compared to a placebo control group.

Should Ozurdex receive regulatory approval, it will be the first treatment for this condition to be ratified for sale in Europe.

David Endicott, president of Allergan in Europe, Africa and the Middle East, said: “Allergan continues to pursue its strategic focus on the development of new treatments for the back of the eye which could help preserve vision for patients with certain retinal diseases.”

Last month, Allergan agreed to collaborate with Serenity Pharmaceuticals on the development of the investigational compound Ser-120, a new treatment for nocturia.