Allergan receives EU approval for new Ozurdex indication

Allergan has welcomed a European Medicines Agency (EMA) decision to approve its drug Ozurdex as a treatment for non-infectious uveitis in the back of the eye.

The European regulatory body has ratified the drug in this new indication based on positive data from the Huron phase III study, in which it was shown to offer safety and efficacy benefits compared to placebo.

Ozurdex is already available in the region as a treatment for macular oedema in patients with retinal vein occlusion.

With this new approval, it becomes the first product approved in Europe for use against both of these eye conditions.

Douglas Ingram, president of Allergan in Europe, Africa and the Middle East, said: "This newest authorisation is consistent with Allergan's continuing commitment to the development of innovative new treatments that serve retinal physicians and help preserve vision for patients suffering from retinal diseases."

This comes after Ozurdex received a provisional National Institute for Health and Clinical Excellence recommendation in its original macular oedema specification, providing that Allergan offers further evidence of its efficacy and cost-effectiveness.