Iluvien receives positive approval from 10 more countries

Atlanta-Alimera Sciences' sustained-release intravitreal implant (Iluvien)-its treatment of chronic macular edema-has received a positive outcome of the Repeat-Use Procedure with the Medicines and Healthcare products Regulatory Agency of the United Kingdom serving as the Reference Member State.

The regulatory process for these 10 additional countries-consisting of Ireland, the Netherlands, Belgium, Luxembourg, Sweden, Denmark, Finland, Norway, Poland, and the Czech Republic-will now enter the national phase in which each country grants marketing authorization.

“Achieving a favorable outcome for (the treatment) in these additional European Union countries is a significant milestone for Alimera and very encouraging for the many patients throughout Europe with this devastating disease,” said Dan Myers, president and chief executive officer of Alimera. “We will continue to work closely with these countries during the national phase to obtain (the treatment’s) marketing authorization in each one.”

Additionally, the Italian Medicines Agency has already granted marketing authorization for the treatment.

Designated a C Class product in Italy, the treatment will be available initially to private-paying patients. Alimera is pursuing H Class designation for the treatment with the Italian regulatory authorities, which, if granted, would expand patient access to the product.

The Italian authorization is the seventh national approval in the European Union, preceded by Austria, the United Kingdom, Portugal, France, Germany, and Spain.

The treatment is commercially available in the United Kingdom and Germany.

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