Alimera Reports Results of Study of Iluvien for Diabetic Macular Edema
October 7, 2009
Alimera Sciences has announced the interim 18-month safety and efficacy results from the first human pharmacokinetic study of Iluvien®. This 36-month, open-label, Phase 2 study, running concurrently with the pivotal Phase 3 FAME™ Study (Fluocinolone Acetonide in Diabetic Macular Edema), is designed primarily to assess systemic exposure of fluocinolone acetonide, after administration of Iluvien in patients with DME (diabetic macular edema). Secondarily, the PK Study is designed to provide information on the safety and efficacy of Iluvien in a DME patient population.
Thirty-seven subjects were enrolled in the PK Study, 20 patients on the low dose of Iluvien (an approximate 0.23 micrograms per day dose), and 17 patients on the high dose of Iluvien (an approximate 0.45?g per day dose).
Data from a subgroup of patients demonstrated that 55 percent of the high dose patients had an improvement in best corrected visual acuity of 10 letters or greater from baseline and 36 percent of the high dose patients had an improvement in BCVA of 15 letters or greater over baseline. Among the low dose patients in the FAME subgroup, 23 percent had an improvement in BCVA of 10 letters or greater from baseline while no patients showed an improvement in BCVA of 15 letters or greater from baseline at this time point.
No patients receiving the low dose of Iluvien experienced an intraocular pressure increases ?30, while 29 percent of the patients receiving the high dose of Iluvien did experience anIOP increase of 30mmHg or greater at some time point.
Read the release.
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