Study Explores Efficacy of Iluvien Implant Efficacy Over 3 Years

Albert J. Augustin, MD

A new report has found that treatment with Iluvien (0.19 mg fluocinolone acetonide [FAc]) in patients with chronic diabetic macular edema (DME) displayed a good safety profile.

Investigators found that the best-recorded visual acuity (BRVA) improved by +5.5 letters at month 9, which was maintained through month 30. Patients improved from 49 letters at baseline to 56.

Investigators from Germany studied 63 patients, or 81 eyes, with persistent or recurrent DME, in order to analyze treatment outcomes with Iluvien. Data was collected retrospectively from patients who were over the age of 18 for an average of 30 months, then analyzed it between September 2016 and September 2017. The patients’ mean age was about 68 years.

The patients received the 0.2 μg/day FAc implant for the treatment of DME at each of the 16 local clinical practices involved in the patient recruitment. The implant is injected into the vitreous and releases a micro-dose of FAc continuously for up to 3 years. While it has a lifespan of 3 years, it has been available in Germany longer than this. Due to the availability, the investigators were able to conduct a real-world retrospective evaluation of FAc outcomes.

Treatments were carried out according to the clinicians’ discretion and the study authors defined visual acuity using 20-80 Early Treatment Diabetic Retinopathy Study (ETDRS) letters. The decision to switch to 0.2 μg/day FAc implant was made based off of one of the following instances: (1) insufficient efficacy during the pre-treatment phase; (2) strong edema; (3) no reaction to visual acuity compared to pre-treatment); (4) high number of recurrences compared to pre-treatment numbers.

Investigators found a concurrent improvement in the central macular thickness, reducing from 502 µm at baseline to 338 µm at year 1. They found that effect lasted to year 3.

Patients’ intraocular pressure remained constant from the baseline to year 3, though the study authors noted a peak change of 1.9 mm Hg occurring at year 1. They also said elevated intraocular pressure was observed in a similar percentage of patients before initiating and following treatment with the implant: 22.2% versus 27.2%, respectively. Investigators determined that these cases of elevated pressure were effectively managed with proper medications.

“I don´t expect a change in the way that physicians treat their patients,” study author Albert J. Augustin told MD Magazine®. “However, now we have scientific evidence that we can offer a drug treatment even in patient who have been treated with approved drug without adequate response (chronic, long standing edema).”

Authors concluded that their paper holds clinically significant outcomes and supports the good benefit-to-risk profile event after patients experience insufficient responses to anti-vascular endothelial growth factor (anti-VEGF) treatments. They added that the study also shows the potential of how using early detection of insufficient responses to intravitreal anti-VEGF may be used in the clinical practice to optimize outcomes in patients with persistent or recurrent DME.

“Despite substantial amounts of prior intravitreal treatments — primarily with anti-VEGF drugs – this real-world study showed that sustained structural and functional improvements can last for up to three years with a single FAc implant,” the study authors concluded.

The paper, titled “Three-year results from the Retro-IDEAL study: Real-world data from diabetic macular edema (DME) patients treated with ILUVIEN® (0.19 mg fluocinolone acetonide implant),” was published in the European Journal of Ophthalmology.