Alimera Reports Safety, Efficacy Results For Human PK Iluvien Study

Alimera Sciences has reported the interim 18-month safety and efficacy results from the first human pharmacokinetic study (PK Study) of Iluvien.

The 36-month, open-label, phase 2 study, running concurrently with the pivotal phase 3 FAME Study, is designed to assess systemic exposure of the corticosteroid, fluocinolone acetonide (FA), after administration of Iluvien in patients with DME.

Secondarily, the PK Study is designed to provide information on the safety and efficacy of Iluvien in a DME patient population. A total of 37 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 micrograms per day dose).

Reportedly among the low dose patients in the FAME subgroup, 23% 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.

Ken Green, chief scientific officer of Alimera Sciences, said: “Although any comparison of visual acuity response between the doses is confounded by the significant differences in baseline mean visual acuity, as well as the small sample size which is susceptible to single patient variability, the trends continue to be consistent with our expectations that sub microgram levels of corticosteroids will benefit this population. The most significant safety signal, namely changes in IOP, continues to favor the low dose vs the high dose.”