36-Month Study of Illuvien for Treatment of Diabetic Macular Edema Shows Positive Results
February 4, 2011
Yesterday, Alimera Sciences reported positive results through month 36 of the completed FAME™ Study, consisting of two three-year, Phase 3 pivotal clinical trials (Trial A and Trial B) to assess the safety and efficacy of ILUVIEN® in the treatment of diabetic macular edema (DME). The primary endpoint for efficacy in the trials was the difference in the percentage of patients whose best corrected visual acuity (BCVA) 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.
The data reported yesterday by Alimera demonstrated statistically significant therapeutic effects with 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 (28.4% of patients gained 15 or more letters); and 18.9% of the control group gained 15 or more letters (p=0.106). Results from Trial B were similar.
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This latest announcement follows Alimera’s prior announcement of a letter from the FDA delaying marketing approval for Illuvien until 36-month results were made available.
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