A real-world safety study of fluocinolone acetonide implant (Iluvien, Alimera Sciences) in patients with chronic DME (328 eyes from 292 patients) showed that 81.6% of patients did not require initiation of IOP-lowering therapy during the study and 60% of patients included in this registry study gained vision after injection of Iluvien that was sustained over the study period.
Take-home: A real-world safety study of fluocinolone acetonide intravitreal implant (Iluvien, Alimera Sciences) in patients with chronic DME (328 eyes from 292 patients) showed that 81.6% of patients did not require initiation of IOP-lowering therapy during the study and 60% of patients included in this registry study gained vision after injection of Iluvien that was sustained over the study period.
Reviewed by Usha Chakravarthy, MBBS
Belfast, Northern Ireland-Analysis of real-world interim data from patients treated with fluocinolone acetonide intravitreal implant (Iluvien, Alimera Sciences), a sustained-release intravitreal implant and the subject of a safety trial in Europe, showed that most patients with chronic diabetic macular edema (DME) who received the device did not require medication to reduce their IOP. Importantly, a substantial percentage of patients experienced sustained gains in visual acuity (VA) over the course of the study following one injection of the device.
The implant, which contains 190 milligrams of the drug, was used in patients with DME in the Iluvien Registry Safety Study (IRISS); at least two thirds of the patients had undergone previous injections of anti-vascular endothelial growth factor (VEGF) agents and a course of corticosteroids. The implant releases fluocinolone acetone over a period of 36 months.
The medication fills an important gap in this patient population, according to Usha Chakravarthy, MBBS, clinical professor, School of Medicine, Dentistry and Biomedical Sciences, Centre for Public Health, Queen’s University of Belfast, Belfast, Northern Ireland, and principal investigator of the IRISS. In patients with DME refractory to anti-VEGF medication, patients were switched to implant when it had been determined that their vision was decreasing and the macular appearance was worsening.
“Following the switch, there were improvements in VA and retinal morphology in the majority of patients. This finding indicated that [the implant] is an important addition to our therapeutic armamentarium,” she said.
The IRISS is a 5-year post-authorization registry study required for all markets in which the product is sold: currently the United Kingdom (26 study sites), Germany (10 study sites), and Portugal (1 study site). The study examined the incidence of IOP increases and their management after patients were treated with the implant and evaluated the status of their VA.
The interim data available from 328 eyes of 292 patients had a mean age of 61.7 years and a mean IOP of 15.4 mm Hg, Dr. Chakravarthy reported.
Fifty-four (18.4%) patients required treatment to lower the IOP and two (0.6%) patients needed surgery to control the IOP, she said.
More than three quarters of the eyes treated (77.4%, n=255 eyes) did not need additional treatments during the period of the study. Of those who did require additional therapies, laser was applied in 5.2%, intravitreal injection of an anti-VEGF drug in 16.8%, steroids in 4.0%, and an implant retreatment in 0.3%.
Effects on VA
The mean change in VA at month 6 after implantation was a gain of about 5 letters (from 50.9 to 55.7 letters), which was sustained up to 18 months after implantation of the device, Dr. Chakravarthy said. After this time point, the mean gain in VA diminished, which was most likely explained by the small number of patients in this cohort who were followed for 21 months or longer, heavily affecting the mean by loss of VA in three patients, according to the study investigators.
At month 6, 15.9% of patients gained 15 letters of vision or more and 20.8% of patients gained 15 letters or more at month 12, the investigators reported.
Most patients had a VA between 34 and 68 Early Treatment of Diabetic Retinopathy Study (ETDRS) letters. After implantation, the distribution changed with more patients having a VA between 69 and 100 ETDRS letters.
Most of the patients in this study had late-stage DME. However, despite this, 3 months after implantation, 58% of patients had a gain in VA that was sustained to month 21 (57%) with a peak of 74% at month 15.
The percentage of patients achieving the needed 6/12 (20/40) acuity for driving level vision increased from a baseline of 18% to 34% at M 12 representing a 16% rate of improvement, the investigators reported.
The results of the interim analysis indicated the patients with long-term DME benefitted from the implant in a way they did not from previous treatment with anti-VEGF drugs, other steroids, and laser application.
The results of the use of the device, which was considered a last-line therapy to be used in an attempt to save or maintain vision in these patients, resulted in useful VA improvements in a significant proportion of patients, some of whom were able to resume driving. The vision improved in 58% of patients 6 months after implantation and 61% at 1 year.
The safety profile of the drug was positive, with 81.6% of patients not requiring any medications to control the IOP.
The patients will continue to be followed for 3 more years.
Another study, the ongoing MediSOFT audit, is a post hoc chart review of electronic medical records data systems used in 13 study centers. The interim data were extracted in February 2016.
“The introduction of [the implant] has been an important addition to our therapeutic armamentarium and in particular for managing DME that is persistent or insufficiently responsive to anti-VEGF therapies,” Dr. Chakravarthy concluded.
Usha Chakravarthy, MBBS
Dr. Chakravarthy has no proprietary interest in any aspect of this report.