Alimera Announces Positive 36-Month Results From The Completed Phase 3 FAME(TM) Study Of ILUVIEN(R) In Patients With Diabetic Macular Edema
Results from Trial B were similar. Statistically significant therapeutic effects of 33.9% at month 30 (p=0.002) and 29.6% at month 33 (p=0.046) of ILUVIEN patients gaining 15 or more letters over baseline were demonstrated, and an effect of 29.0% (p=0.086%) was seen at month 36 compared to the control group, which had fewer than 18% of patients making such gains. At month 36, 29.0% of ILUVIEN patients gained 15 or more letters compared with 18.9% of control patients (p=0.086).
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 (p=0.029). In Trial B, 30.6% of ILUVIEN patients and 17.8% of control patients (p=0.030) gained 15 letters or greater over baseline.
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 (p=0.002) having an improvement in BCVA of 15 letters or greater over baseline at month 24, 31.4% versus 15.1% at month 30 (p=<0.001), 29% versus 17.3% at month 33 (p=0.004) and 28.7% versus 18.9% at month 36 (p=0.018).
"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.
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