Lower-dose fluocinolone acetonide (Iluvien, Alimera Sciences) was most effective in patients with diabetic macular edema (DME) who had the disease for 3 years or more, according to a recent analysis of the data from the 36-month FAME study, presented by Andrew N. Antoszyk, MD, at ARVO.1
The FAME study consisted of two identical, double masked, sham-controlled, multicenter, phase 3 studies—trial A and trial B—and included 956 patients with DME. Participants were randomized 2:2:1 to receive 0.2 μg fluocinolone acetonide (n = 376), 0.5 μg fluocinolone acetonide (n = 395), or control/sham (n = 185). The primary endpoint was the proportion of patients who gained 15 letters or more in best corrected visual acuity (BCVA) at month 24. As previously reported, the prespecified primary endpoint for the FAME study was met for low-dose fluocinolone acetonide in both trial A and trial B.
“The FAME trial showed that it did meet its primary readout, but the question arose, ‘Was there a particular subgroup of patients with DME that had a greater benefit- to-risk ratio?'” Dr. Antoszyk said. “The ideal subgroup would have to have a statistically significant visual acuity result at months 24 and 36, a greater benefit-to-risk ratio, and should be identifiable prior to administration of the Iluvien implant.”
The subgroups consisted of 536 patients who had had DME for 3 years or more and 416 patients who had had DME for less than 3 years. Of the fluocinolone acetonidetreated patients with DME for 3 years or more, 33.6% in trial A and 42.4% in trial B achieved an improvement in BCVA of 15 letters or more at month 30. At month 36, 31.8% of the patients in trial A and 36.4% of the patients in trial B had an improvement in BCVA of 15 letters or more.
Of the patients who received the control treatment, 13.6% in trial A and 13.2% in trial B had an improvement in BCVA of 15 letters or more at 36 months. No statistically significant improvement in BCVA was observed in the subgroup of patients with DME of less than 3 years' duration. Consistent with the full patient population, approximately 75% of the patients treated with fluocinolone acetonide received only 1 insert during the 36-month study.
At 36 months, the IOP had increased to 30 mm Hg or more at any time point in 14.8% of fluocinolone acetonide-treated patients in the subgroup vs 18.3% of fluocinolone acetonidetreated patients in the full patient population. In addition, 5.3% of fluocinolone acetonide-treated patients in the subgroup underwent an incisional surgical procedure to reduce elevated IOP compared with 4.8% in the full patient population. In the subgroup, the incidence of cataracts among fluocinolone acetonide- treated patients who had a natural lens at baseline was 86%, with 85% undergoing a cataract operation, compared with 80% and 74.9%, respectively, in the full patient population. Based on the results of the FAME study, Alimera has submitted a new drug application to the FDA for regulatory approval of lower-dose fluocinolone acetonide.
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