36-month data demonstrate Iluvien effective for DME

Atlanta-Sustained-release fluocinolone acetonide (Iluvien, Alimera Sciences) demonstrates statistically significant effectiveness in the treatment of diabetic macular edema (DME), according to recently released 36-month data from the FAME Study.

The trial consisted of two 3-year, phase III pivotal clinical trials (trial A and trial B) to assess the safety and efficacy of the intravitreal insert containing 190 µg of the corticosteroid. Patients in the trials were randomly assigned to receive either a higher dose with an initial release of approximately 0.45 µg per day, a lower dose with an initial release of approximately 0.23 µg per day, or control treatment.

The primary endpoint for efficacy in the trials 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.

In trial A, 28.9% of patients taking the drug had a gain of 15 or more letters at month 30 (p = 0.011), compared with the control group, and 28.4% had such a gain at month 33 (p = 0.042). In the control group, less than 17% of patients gained 15 or more letters.

In trial B, 33.9% of patients taking the drug had a gain of 15 or more letters at month 30 (p = 0.002), compared with baseline, and at month 33, 29.6% of patients saw such a gain (p = 0.046). In the control group, less than 18% of patients had such gains. At month 36, 29.0% of patients taking the drug had a gain of 15 or more letters compared with 18.9% of patients in the control group (p = 0.086).

“We believe the statistical significance observed in both trials at month 33 meets the criteria for replication of efficacy in the two studies,” said Susan Caballa, senior vice president of regulatory affairs at Alimera. “We will provide [these] safety and efficacy data to the FDA so that it will have the opportunity to review [them] as part of our pending new drug application for [sustained-release fluocinolone acetonide] for the treatment of DME.”