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Alimera Sciences reports 3-month results for Medidur FA implant study
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ATLANTA — Alimera Sciences has reported 3-month month safety and efficacy results from the first human pharmacokinetic study of its Medidur FA implant for treating patients with diabetic macular edema. If approved by the U.S. Food and Drug Administration, Alimera plans to market the device under the brand name Iluvien, according to a press release from the company.
Each Iluvien insert is designed to provide a sustained therapeutic effect for up to 24 months for low doses and up to 36 months for high doses, the release said.
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).
Inclusion and exclusion criteria for the study mirrors the FAME trial, the release said.
According to interim results, 20% of the low-dose patients and 18% of the high-dose patients achieved an improvement in best corrected visual acuity of 15 letters or greater from baseline. In addition, both the low dose and the high dose of Iluvien significantly reduced retinal thickness, according to the release.
No adverse events related to IOP were seen in the low-dose patients, while 12% of the high-dose patients experienced IOP spikes greater than 30 mm Hg; one patient in the high-dose group had cataract formation.
Data from this study will be evaluated on an ongoing basis, with interim results reported at 6, 12, 18, 24, 30 and 36 months.