A type II variation submission for Iluvien has been accepted in Europe, Alimera Sciences announced in a press release.
The variation, submitted through the Mutual Recognition Procedure with the Medicines and Healthcare Products Regulatory Agency in the United Kingdom, asks to add recurrent and persistent noninfectious uveitis of the posterior segment to the indication for Iluvien (fluocinolone acetonide intravitreal implant 0.19 mg).
The implant is currently indicated in Europe to treat chronic diabetic macular edema.
Results from two randomized, double-masked, multicenter phase 3 clinical trials, which compared the proportion of patients who did not experience a recurrence of noninfectious uveitis of the posterior segment, were submitted by Alimera. The primary endpoint was met in both studies, the release said.