Phase 3 studies of Iluvien for the treatment of diabetic macular edema (DME)

pSivida Corporation announced top-line readout results from two Phase 3 studies of Iluvien (sustained release fluocinolone acetonide insert) for the treatment of diabetic macular edema (DME). Alimera Sciences (a licensee of pSivida) conducted two 36-month trials (Trial A and Trial B, collectively known as the FAME Study) for Iluvien with two doses (a high and low dose) in 956 patients. The primary efficacy endpoint for the FAME Study was the difference in the percentage of patients whose best corrected visual acuity improved by 15 or more letters from baseline on the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart at month 24 between the treatment and control groups.

Alimera reported that data through month 36 for the Full Analysis Set in Trial A demonstrated statistically significant therapeutic effects of 28.9% at month 30 (p= 0.011) and 28.4% at month 33 (p= 0.042) of Iluvien patients gaining 15 or more letters compared to the control group, in which fewer than 17% of patients gained 15 or more letters. The therapeutic effect was maintained at month 36 (with 28.4% of patients gaining 15 or more letters); however, as 18.9% of the control group gained 15 or more letters, the p value increased to p=0.106. Results from Trial B reported by Alimera were similar. Trial A and B data combined demonstrated a statistically significant effect at week three, and this effect was maintained throughout the 36 months.

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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