Alimera Sciences 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 16 European member states seeks to add the indication of recurrent and persistent noninfectious uveitis affecting the posterior segment (NIU-PS) to the Iluvien label in Europe. All 17 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 filed for this variation in 2017 ahead of schedule,” Dan Myers, president and CEO of Alimera, said in a company news releaes. “We are grateful to our partner pSivida for the support they have provided and we look forward to working with the regulatory authorities to make Iluvien available for uveitis patients in these 17 countries.”
Alimera submitted the results from two, randomized, double-masked, multicenter phase 3 clinical trials, with the primary endpoint at 6 months comparing the proportion of patients who do not experience a recurrence of NIU-PS. In both studies, the primary endpoint was met.