Phase 3 Study of Iluvien for Diabetic Macular Edema

pSivida Corp. announced new data from its Phase 3 study of Iluvien (sustained release fluocinolone acetonide insert) for the treatment of diabetic macular edema. This data analyzed the subgroup of patients (n=536) who had been diagnosed with DME for three or more years at entry of the FAME Study. Alimera Sciences (a licensee of pSivida) plans to submit the new subgroup data to the FDA in support of its pending NDA.

The data reported for this subgroup analysis at 36 months showed that in Trial A, 31.8% of patients treated with Iluvien experienced an improvement in best corrected visual acuity of 15 or more letters from baseline compared with 13.6% of those in the control group (P=0.010), for a net benefit of Iluvien vs. control of 18.2%. In Trial B, 36.4% of Iluvien patients experienced improvement of 15 or more letters compared to 13.2% of control patients (P=0.004), for a net benefit of Iluvien vs. control of 23.2%. For both Trials A and B at three years, the net benefit of Iluvien compared to control was 20.6%, more than double that was seen for the full patient population (9.8%).

Iluvien is an extended-release intravitreal insert. It is inserted in the back of the patient’s eye to a position that takes advantage of the eye’s natural fluid dynamics. The insertion device employs a 25-gauge needle, which allows for a self-sealing wound. 

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