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28.4% and 29.0% demonstrated improvement in best corrected visual acuity (BCVA) of 15 letters from baseline, at three years. Statistical significance seen in both trials as late as month 33.
Alimera will host a conference call and slide show presentation at 4:30 PM ET today to discuss these results and additional data from the FAME Study.Peter Campochiaro, M.D., will present results at Angiogenesis, Exudation and Degeneration 2011, February 12, in Miami, Fla.
ATLANTA, Feb. 3, 2011 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (Nasdaq:ALIM) ("Alimera"), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today reported results through month 36 of the completed FAME™ Study.
The FAME Study consisted 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). Patients in the trials were randomized to receive either high dose ILUVIEN, low dose ILUVIEN or control treatment. 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.
Alimera previously presented data for both the low and high dose patient results at month 24. Based on these data, Alimera submitted a New Drug Application (NDA) on June 29, 2010 for approval of only the low dose. Therefore, only the low dose data is presented and discussed in this release.
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 (28.4% of patients gained 15 or more letters); and 18.9% of the control group gained 15 or more letters (p=0.106).