The USER Study: A Chart Review of Patients Receiving a 0.2 µg/day Fluocinolone Acetonide Implant for Diabetic Macular Edema

Abstract

Introduction To determine anatomical, functional, and intraocular pressure (IOP) responses to diabetic macular edema (DME) treatments pre- and post-0.2 µg/day fluocinolone acetonide (FAc) implant administration compared with baseline and the preceding 3 years. Methods This was a retrospective, chart review, cohort study in four U.S. centers. Patients received the 0.2 µg/day FAc implant for the treatment of DME in at least one eye before January 1, 2016. DME treatments administered up to 36 months pre-FAc implant and up to 24 months post-FAc implant were recorded, and treatment frequency was calculated. Visual acuity (VA) was assessed using a Snellen eye chart and converted to early treatment diabetic retinopathy study (ETDRS) letters, and central subfield thickness (CST) was measured using optical coherence tomography (OCT). Treatment frequency, mean VA, mean CST, percentage of patients with CST of ≤ 300 µm, mean IOP, IOP events, and IOP treatments pre- and post-FAc implant administration were measured. Positive and negative predictive values for the IOP response to prior steroid therapy were also determined. Results In total, 160 eyes of 130 patients were studied. VA was maintained at pre-FAc levels from baseline to month 24, despite a significant reduction in treatment frequency from one treatment every 2.9 months pre-FAc implant to one treatment every 14.3 months post-FAc implant. Patients with better baseline VA required fewer DME treatments post-FAc than did patients with worse baseline VA. The majority of patients did not require additional DME treatment during the post-FAc follow-up period. A significant reduction in CST and an increase in the percentage of patients with CST of ≤ 300 µm were seen up to month 21 post-FAc implant. Pre-FAc implant IOP was maintained during the post-FAc implant period; increased IOP with prior steroid therapy was found to be highly predictive of increased IOP post-FAc implant. Conclusion The results of this study confirm the positive safety and efficacy profile of the FAc implant and demonstrate for the first time the effectiveness of the U.S. label indication of FAc in reducing the incidence of post-treatment pressure elevation. The FAc implant significantly reduced treatment burden in the overall population without significantly increasing the risk of steroid-induced pressure elevation. Funding Alimera Sciences.

<p>Rapid Structural and Functional Improvements with the 0.19 mg Fluocinolone Acetonide Intravitreal Implant for Patients with DME and Low Visual Acuity: 6-Month Data from the UAE</p>

“…Data from clinical real-world studies have established the safety profile of the FAc intravitreal implant in patients with DME that persists or recurs despite treatment, and the current study revealed no new safety findings. Indeed, patients previously exposed to a course of corticosteroids appear to have fewer IOP elevations after FAc implantation than those who have not been exposed to prior course of corticosteroids, 20,21 and the IOP increases that were observed in this study are in line with previously reported findings.…”

“…This is consistent with the findings of the USER study, in which the percentage of patients achieving a dry macula significantly increased after FAc implantation. 21 It should be noted, however, that the follow-up period in the USER study was longer than in the current study.…”

“…10 The United Arab Emirates (UAE) Health Authority approved reimbursement for the FAc intravitreal implant in October 2016 for patients with DME who have previously received a course of corticosteroids and did not have a significant rise in intraocular pressure (IOP). 19 A number of multicenter real-world studies including the Medisoft audit in the UK, 20 the USER study in the USA, 21 the IRISS study in Germany, Portugal and the UK, 22 and the RESPOND study in Portugal, 23 have confirmed the safety and effectiveness profile previously demonstrated in clinical trials. To our knowledge, no study has yet examined the effectiveness and safety of the FAc intravitreal implant in clinical practice in a UAE population.…”

Macular thickness amplitude changes when switching from discontinuous to continuous therapy for diabetic macular oedema

“…The low-dose FAc implant was ultimately FDA-approved as it met the primary endpoint where 33% of patients gained 15 letters or more from their baseline best-corrected visual acuity (BCVA) at 3 years as opposed to 21% in the placebo group. Furthermore, in the US Retrospective Chart Review in Patients Receiving Iluvien (USER) clinical study, treatment with FAc showed that in 160 eyes, 63% of the eyes required no additional treatment for DME 19…”

Fluocinolone acetonide (0.19 mg) intravitreal implant reduces treatment burden and improves practice resource utilisation for patients with diabetic macular oedema

“…Large real-world studies in Europe and the USA demonstrated a significant reduction in injection burden after receiving the FAc implant while maintaining or improving VA and optical coherence tomography (OCT) central subfield thickness (CSFT) 14 15. There are, however, little or no studies assessing its impact on patient visits and also practice resource utilisation (based on ophthalmic visits and injection burden) so we now examine these aspects in our clinical practice.…”