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Alimera Sciences reports 18-month safety, efficacy study results for implant
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ATLANTA — Alimera Sciences has reported 18-month safety and efficacy results from the first human pharmacokinetic study of its Iluvien implant for treating patients with diabetic macular edema.
The 36-month, open-label, phase 2 study - which is being conducted concurrently with the pivotal phase 3 FAME (Fluocinolone acetonide in diabetic macular edema) trial - is evaluating the systemic exposure of fluocinolone acetonide after administering one of two dose concentrations of Iluvien to 37 patients with diabetic macular edema. Specifically, 20 patients received approximately 0.23 µg of Iluvien daily and 17 patients received approximately 0.45 µg daily.
According to 18-month interim data, 55% of patients who received the higher dose of Iluvien achieved an improvement in best corrected visual acuity of 10 or more letters from baseline; in addition, 36% of the high-dose patients achieved an improvement in BCVA of 15 or more letters during the same period. Data from this subgroup of patients reflects the same visual acuity inclusion criteria as that of the larger FAME trial, according to a press release from the company.
A total of 23% of patients who received the lower dose of Iluvien had an improvement in BCVA of 10 letters or greater from baseline; however, none of these patients showed an improvement in BCVA of 15 or more letters during the same period.
No patients receiving the low dose of Iluvien experienced IOP spikes of 30 mm Hg or greater, while 29% of the patients receiving the high dose of Iluvien experienced IOP spikes of 30 mm Hg or greater at some time point during the 18-month period.
"Although any comparison of visual acuity response between the doses is confounded by the significant differences in baseline mean visual acuity, as well as the small sample size which is susceptible to single patient variability, the trends continue to be consistent with our expectations that sub-microgram levels of corticosteroids will benefit this population," Ken Green, PhD, chief scientific officer of Alimera Sciences, said in the release. "The most significant safety signal, namely changes in IOP, continues to favor the low dose vs. the high dose."