Low dose Medidur FA safe and effective in DME

July 8, 2008

Low doses of Alimera Sciences' Medidur FA provide visual acuity improvements and reduce the risk of ocular side effects commonly associated with corticosteroids, when administered to diabetic macular oedema (DME) patients, according to the three-month interim results of the first human pharmacokinetic (PK) study.

Low doses of Alimera Sciences' Medidur FA provide visual acuity improvements and reduce the risk of ocular side effects commonly associated with corticosteroids, when administered to diabetic macular oedema (DME) patients, according to the three-month interim results of the first human pharmacokinetic (PK) study.

If approved by the FDA, Alimera intends to market the product under the trade name Iluvien. Each Illuvien intravitreal insert, which is delivered with a 25-gauge needle, has been designed to provide a sustained therapeutic effect for 24-36 months, depending on the dose of the corticosteroid, fluocinolone acetonide, administered within the insert.

The 36-month, open-label, Phase II PK study, which is running simultaneously with the pivotal Phase III FAME trial (Fluocinolone Acetonide in Diabetic Macular Edema), was designed to assess the systemic exposure to the corticosteroid as well as to provide information on the safety and efficacy of Iluvien in DME patients.

Thirty-seven patients were enrolled into the study in total, 20 of whom received low dose Iluvien (approximately 0.23 µg/day), whilst the remaining 17 patients received high dose Iluvien (approximately 0.45 µg/day).

At three months, 20% of the low dose patients and 18% of the high dose patients showed an improvement in best corrected visual acuity of 15 letters or more and a significant decrease in retinal thickness was noted in both groups. Although no intraocular pressure (IOP) related side effects were apparent in the low dose group, 12% of high dose patients experienced an increase in IOP of more than 30 mmHg. Only one incidence of cataract was reported in the high dose group.

Alimera will now continue to assess the results of the PK study at quarterly intervals.