Alimera Sciences reports 12-month results for Iluvien implant study

ATLANTA — Alimera Sciences has reported 12-month safety and efficacy results from the first human pharmacokinetic study of its Iluvien implant for treating patients with diabetic macular edema.

Each Iluvien insert is designed to provide a sustained therapeutic effect for up to 36 months for low doses and up to 24 months for high doses, according to a press release from the company.

The 36-month open-label phase 2 study — which coincides with the pivotal phase 3 FAME (Fluocinolone acetonide in diabetic macular edema) study — is evaluating the systemic exposure of fluocinolone acetonide after administering one of two dose concentrations of Iluvien to 37 patients with DME. Specifically, 20 patients received approximately 0.23 µg of Iluvien daily (low dose) and 17 patients received approximately 0.45 µg daily (high dose).

According to 12-month interim results, 23.1% of the low-dose patients and 27.3% of the high-dose patients achieved an improvement in best corrected visual acuity of 15 letters or greater from baseline, according to the release.

No adverse events related to IOP were seen in the low-dose patients, while 23.5% of the high-dose patients experienced IOP spikes greater than 30 mm Hg.

Data from this study will be evaluated on an ongoing basis, with interim results reported at 18, 24, 30 and 36 months.