Results from the Six-Month Interim Readout of the Human PK Iluvien™ Study
News Oct 07, 2008
Drug delivery company, pSivida Corp. together with its licensing and development partner, Alimera Sciences have reported the interim six-month safety and efficacy results from the first human pharmacokinetic study of Medidur™ FA, which will be marketed under the trade name Iluvien™, if approved by the U.S. Food and Drug Administration.
This 36 month, open label Phase II study, running concurrently with the pivotal Phase III FAME™ study (Fluocinolone Acetonide in Diabetic Macular Edema), is designed primarily to assess systemic exposure of the corticosteroid, fluocinolone acetonide (FA) after administration of Iluvien in diabetic macular edema (DME) patients.
The study is also designed to provide information on the safety and efficacy of Iluvien in a DME population. A total of 37 subjects were enrolled in the PK study, 20 patients received a low-dose Iluvien and 17 patients received a higher-dose Iluvien.
The six-month interim readout from the PK study showed 25% of the low dose patients and 41% of the higher dose patients had an improvement in best corrected visual acuity (BCVA) of 10 or more letters on an eye chart compared with their baseline vision. In addition, the sixmonth readout showed 18% of the higher dose patients had an improvement in BCVA of 15 or more letters from baseline.
The percentage of low dose patients that had an improvement in BCVA of 15 or more letters from baseline decreased from the 20% seen at the three-month readout due to one patient having developed a cataract and one patient having developed an epiretinal membrane involving the macula prior to the readout. The development of cataracts and epiretinal membranes in a diabetic population are not unusual and are commonly addressed with surgical intervention.