25 March 2019 - Regulatory process to now enter the national phase in which each member state finalises the label to meet local requirements.

Alimera Sciences today announced a positive outcome for a new indication for Iluvien in Europe. Alimera received the Final Variation Assessment Report (FVAR) for Iluvien from the Medicines and Healthcare products Regulatory Agency of the United Kingdom (MHRA) based on Alimera's submission to the MHRA through the Mutual Recognition Procedure. Under that procedure, the United Kingdom has acted as the Reference Member State and prepared an assessment report to share with the 16 other countries in the EEA in which Alimera applied for an additional indication. The FVAR states that Iluvien is approved for the additional indication for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye (NIPU). NIPU, which is difficult to treat and primarily affects working age people, can lead to severe vision loss and even blindness.

Upon German approval of the NIPU label, Alimera can launch Iluvien for NIPU in Germany without having to pursue reimbursement per the Arzneimittelmarkt-Neuordnungsgesetz (AMNOG) law because fluocinolone acetonide, the active ingredient in Iluvien, was available on the German market prior to January 2011.

Read Alimera Sciences press release