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.
Peter Campochiaro, M.D., will present results at Angiogenesis, Exudation and Degeneration 2011, February 12, in Miami, Fla.
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.
Results from Trial B were similar.
By comparison, at month 24 in Trial A, 26.8% of ILUVIEN patients and 14.7% of control patients had gained 15 or more letters.
As previously reported, Trial A and B data combined demonstrated a statistically significant effect at week three. This effect was maintained throughout the 36 months, with 28.7% of ILUVIEN patients and 16.2% of control patients.
"This consistent response rate at month 24 and month 36, with a peak rate of 31.4% in month 30, is encouraging, and we believe demonstrates that ILUVIEN can provide a long-term option for the treatment of DME for up to three years," said Dan Myers, president and CEO of Alimera Sciences.
The Full Analysis Set includes 376 patients in the ILUVIEN arm and 185 patients in the control arm with data imputation employed using last observation carried forward (LOCF) only for missing data. Data for the Full Analysis Set includes 190 patients in Trial A and 186 patients in Trial B randomized to the ILUVIEN arm.
Safety was assessed for all patients treated with ILUVIEN in the study. Intraocular pressure (IOP) increases to 30 millimeters of mercury (mmHg) or greater at any time point had been seen in 18.4% of the patients by month 36 compared to 16.3% by the month 24 readout. By month 36, 4.8% of patients had undergone an incisional surgical procedure to reduce elevated pressure versus 3.7% of patients by month 24. The incidence of cataract among patients with a natural lens in their eye at the start of the trial was 81.7% at month 36, with 80% undergoing a cataract operation, compared to 80% and 74.9%, respectively, at the time of the month 24 readout.
"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 this safety and efficacy data to the FDA so that it will have the opportunity to review it as part of our pending NDA for ILUVIEN for the treatment of DME."
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