Two real world data sources, revealed at the Royal College of Ophthalmologists (RCOphth) Annual Congress, show that the majority of chronic diabetic macular edema (DME) patients who received a single Iluvien (190µg Fluocinolone Acetonide intravitreal implant in applicator) injection in routine clinical practice gained or maintained vision at 12 months, according to an Alimera Sciences news release.
Patient vision outcomes were comparable to the phase 3 clinical trial (FAME) results, despite the patients having more prior intravitreal treatments and more chronicity of DME than those included in the FAME trials. Raised IOP and other side effects were consistent with those seen in the phase 3 trials.
The two real world data sources consist of a European registry study and an audit of UK clinical practice:
• The Iluvien Registry Safety Study (IRISS) is a post authorization safety study that Alimera is required to perform. Interim data presented at the RCOphth congress is from 328 eyes (292 patients) from 25 centres in the UK, 10 in Germany and 1 in Portugal. IRISS collects primary data on safety and some visual acuity but no data from optical coherence tomography (OCT).
• The ongoing “Medisoft” audit has gathered data on 290 eyes (258 patients) from the Medisoft EMR data systems used in 13 UK centers. Medisoft collects retrospective safety data and best collected vision and some data from OCT.
Interim results from IRISS show that 81.6% of patients required no emergent IOP-lowering medication, 9.9% had an IOP increase of ≥10mm Hg and 8.2% had an IOP elevation of above 30mm Hg.
There were 51 phakic eyes treated in the study of which 14 (27.4%) of these had a cataract extraction concurrent with their Iluvien injection, 5 (9.8%) phakic eyes went on to develop treatment emergent cataract and 10 (19.6%) underwent a cataract extraction.
Duration of DMO prior to Iluvien injection was 4.59 years in the IRISS patient cohort.
Vision improved in 58% of IRISS patients at 6 months and 61% at 12 months, which is comparable with the FAME trials. Mean visual acuity increased from 50.9 letters at baseline to 55.7 letters at 6/12 months, with 15.9% of patients gaining ≥15 letters at 6 months and 20.8% of patients gaining ≥15 letters at 12 months. 27% of patients at 6 months and 34% at 12 months regained vision that was better than 6/12, which is the DVLA’s minimum requirement for driving in the UK.
In contrast with the FAME studies, where all patients had prior laser therapy few had received anti-vascular endothelial growth factor (anti-VEGF) therapies, in the IRISS study at least two thirds are known to have received prior anti-VEGF injections.
Similar to the IRISS study, data from the interim Medisoft audit show that at least 85.2% of patients required no emergent IOP-lowering medication. In the 14.8% of patients who did require emergent IOP management, IOP changes were consistent with the FAME trials and well managed.
In the small number of phakic patients included in the Medisoft audit, cataract progression was comparable to that seen in phakic patients in the FAME trials at a similar time point. The mean change in foveal thickness at the last observation was -148.5 µm (P < .001).
Professor Usha Chakravarthy from Queen’s University Belfast, principal investigator of the IRISS study said: “In these real world studies, patients were switched to Iluvien when clinicians had determined that despite other treatments there was vision decline and worsening appearance of the macula. Following the switch there were improvements in visual acuity and retinal morphology in the majority of patients showing that Iluvien is an important addition to our therapeutic armamentarium.”
Miss Clare Bailey from Bristol Eye Hospital, who leads the Medisoft audit added: “Since the Iluvien phase 3 registration clinical trials were conducted in 2005-2011, the management of patients with DME has changed significantly with the widespread use of anti-VEGF agents. These data demonstrate that in the real world, Iluvien can improve or preserve vision with a side effect profile similar to that seen in the phase 3 FAME studies in the majority of patients with DME, even when previous anti-VEGF treatments have failed to deliver a sufficient response and we are very pleased to have it as a treatment option for our patients following NICE approval.”
Professor Yit Yang, New Cross Hospital, Wolverhampton and Chairperson for Alimera Sciences scientific meeting on May 23, 2016 “The UK Experience with Iluvien in Clinical Practice: Real World Outcomes and Case Studies” commented: “The clinical scenario of a patient with chronic DME who has not responded to anti-VEGF is unfortunately quite common in everyday practice. For the first time, we have evidence to show that patients in this situation can gain by switching to Iluvien therapy. The results on the small proportion of phakic patients are also encouraging and may pave the way for approval of Iluvien in those patients who have chronic DME that has not responded to anti-VEGF agents but are phakic.”