pSivida reports positive interim results from diabetic macular edema study

pSivida, a drug delivery company, has reported encouraging interim 12-month safety and efficacy results from the first human pharmacokinetic study of Iluvien. The study is being conducted by the company’s licensing partner Alimera Sciences. Iluvien is an intravitreal insert being developed for the treatment of diabetic macular edema.

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, after administration of Iluvien in patients with diabetic macular edema (DME).

Secondarily, the pharmacokinetic (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 0.23mcg per day dose), and 17 patients on the high dose of Iluvien (an approximate 0.45mcg per day dose).

Efficacy data from the subgroup of patients with the same visual acuity inclusion criteria as the larger Phase III Fame trial revealed that 27.3% of the high dose patients had an improvement in best corrected visual acuity (BCVA) of 15 letters or greater over baseline and 23.1% of the low dose patients had an improvement in BCVA of 15 letters or greater over baseline.

In the 12-month interim readout, no adverse events related to intraocular pressure (IOP) were seen in low dose patients, and 23.5% of the high dose patients experienced IOP increases of 30mmHg or greater at some time point and one of those patients required surgery to address their elevated IOP, the company said.

Paul Ashton, president and CEO of pSivida, said: We are extremely pleased that the 12 month interim safety analysis of Iluvien is consistent with the results that were seen at the three and six month readouts.