Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Alimera Sciences has reported the safety and efficacy results from the first human pharmacokinetic study of Medidur FA, which it intends to market under the tradename Iluvien, if approved by the FDA.
Subscribe to our email newsletter
This 36-month, open-label Phase II study, running concurrently with the pivotal Phase III Fame study is designed primarily to assess systemic exposure of the corticosteroid, fluocinolone acetonide (FA), after administration of Iluvien in diabetic macular edema (DME) patients.
Secondarily, the study is designed to provide information on the safety and efficacy of Iluvien in a DME population. A total of 37 subjects were enrolled in this trial, 20 patients on the low dose (an approximate 0.23 microgram per day dose) of Iluvien, and 17 patients on the high dose (an approximate 0.45 microgram per day dose) with the same inclusion/exclusion criteria as the ongoing Phase III Fame study.
This three-month interim readout from the pharmacokinetic (PK) study indicated 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 greater from baseline.
In addition, both the low dose and the high dose of Iluvien resulted in a significant reduction in retinal thickness as compared to the baseline.
Ken Green, chief scientific officer of Alimera, said: “We believe this early readout from our PK study supports our premise that lower doses of FA delivered by Iluvien will provide visual acuity improvements while reducing the risk of ocular side effects commonly associated with the use of corticosteroids.”