Favorable safety, efficacy seen in 12-month interim results for fluocinolone

Atlanta

-Alimera Sciences Inc., has made available the interim, 12-month safety and efficacy data from the first human pharmacokinetic study of fluocinolone acetonide intravitreal insert (Iluvien), which is currently under development for the treatment of diabetic macular edema, the company said in a prepared statement.

The novel injectable intravitreal insert delivers a low dose of corticosteroids to the retina for up to 3 years. The injection is administered by an ophthalmologist using a proprietary 25-gauge injector system (Medidur) into the vitreous through a minimally invasive procedure.

For this 36-month, open-label, phase II study, 37 patients were enrolled. Twenty patients were treated with a low dose of fluocinolone (approximately 0.23 μg/d), and 17 patients were treated with a high dose (approximately 0.45 μg/d). Data from the 12-month interim results show that no adverse events related to IOP were seen in patients treated with the low dose, whereas 23.5% of patients treated with the high dose had IOP increases of 30 mm Hg or greater at some point.

“This profile of IOP changes occurring only in the high-dose group is consistent with the IOP change profiles that were seen at the 3- and 6-month readouts,” said Ken Green, PhD, chief scientific officer of Alimera Sciences. “Given the lower incidence of IOP changes of 33 mm Hg or greater observed with [the insert], as compared with published clinical data on a fluocinolone acetonide intravitreal implant [Retisert, Bausch & Lomb], [The insert] may offer an important safety advantage in the delivery of fluocinolone acetonide.”

Data from a subgroup of patients showed that approximately 27.3% of patients treated wit the high dose and 23.1% of patients treated with the low dose experienced an improvement in best-corrected visual acuity of 15 letters or more over baseline.

Further interim results from this pharmacokinetic study will be evaluated at months 18, 24, 30, and 36.