The Iluvien fluocinolone acetonide intravitreal insert (Alimera Sciences, Inc) is safe and effective in the management of diabetic macular oedema (DME) at twelve months, according to study results released by Alimera.

The ongoing 36-month Phase II open-label pharmacokinetic study is designed to assess the extent of systemic exposure to fluocinolone acetonide following Iluvien implantation and to assess the safety and efficacy of the insert. Of the 37 patients enrolled in the study, 20 received a dose of 0.23 µg daily, and the remaining 17 received 0.45 µg per day.

Of the patients on the high dose, 27.3% experienced a 15 letter or greater increase in best corrected visual acuity (BCVA); among low dose patients, this was 23.1%. None of the low-dose patients experienced intraocular pressure (IOP)-related adverse events; however, 23.5% of the high dose patients suffered IOP increases of ≥30 mmHg at some point throughout the study period. This was no increase over the IOP raises seen at the previous three and six month follow-up visits.

Alimera claims that these results are as expected for Iluvien at this time point. The next data will be available from the study at the 18-month time point.