Alimera Sciences Receives Acceptance of Filing to Obtain Approval for ILUVIEN® Non-Infectious Posterior Uveitis Indication in Europe
Alimera Sciences, Inc. (ALIM)
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Source: GlobeNewswire
ATLANTA, Jan. 04, 2018 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (NASDAQ:ALIM) (Alimera), a leader in the commercialization and development of prescription ophthalmic pharmaceuticals, today announced that it received validation of a Type II variation for ILUVIEN submitted on December 12, 2017. The Type II variation was submitted through the Mutual Recognition Procedure with the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom as the Reference Member State. The submission to the MHRA and sixteen European member states seeks to add the indication of recurrent and persistent non-infectious uveitis affecting the posterior segment (NIU-PS) to the ILUVIEN label in Europe. All seventeen bodies have accepted the submission. ILUVIEN is Alimera’s sustained release intravitreal implant currently indicated in Europe to treat vision impairment associated with chronic DME considered insufficiently responsive to available therapies. “We are very pleased to have fi
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