The impact of prior steroid therapy on safety outcomes following treatment with ILUVIEN (fluocinolone acetonide) – An analysis of intra-ocular outcomes (IOP) from UK electronic medical records.

Abstract

Purpose : To date, the impact of prior steroid therapy on the safety outcomes with ILUVIEN has not been reported in real-world clinical practice. This post-hoc analysis assessed the correlation of prior ocular steroid exposure with incidence of IOP elevations (>30mmHg) after intravitreal injection of the ILUVIEN implant.

Methods : The Medisoft^TM EMR audit retrospectively collected anonymised patient data from 345 eyes / 305 DMO patients from 14 UK NHS centres and patients data with IOP increase >30 mmHg post-ILUVIEN was statistically analysed to assess the effect of prior steroid exposure as a predictive factor.

Results : Mean follow-up was 428 days. In the whole population, 7.2% of eyes experienced a rise in IOP above 30 mmHg and 13.9% required IOP-lowering drops following ILUVIEN therapy. In the prior steroid group 0% of eyes had a rise in IOP >30 mmHg if there was no history of prior IOP-related events versus 14.5% (P=0.008) if there was a history of prior IOP-related events. Similar findings (P=0.009) were observed in the no prior steroid group with 4.9% vs 14.9% (no history vs an existing history of prior IOP-related events) of eyes experiencing a rise in IOP >30 mmHg (see figures).

Conclusions : This real-world safety data shows the best safety outcomes are achieved in eyes where there is no history of prior IOP-related events. Eyes with prior steroid therapy without secondary IOP rise did not develop an IOP rise to more than 30 mmHg following ILUVIEN.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.

 

IOP-related events in ILUVIEN-treated patients without prior steroid treatment.

 

IOP-related events in ILUVIEN-treated patients with prior steroid treatment.