Results from the 3-year European Iluvien Registry Safety Study that examined outcomes of the fluocinolone acetonide implant compared to those of the pivotal FAME trials.
Ramin Khoramnia, FEBO
In a study commissioned by the European Medical Agency, investigators found that patients with diabetic macular edema (DME) who had suboptimal responses to predominantly anti-VEGF agent treatments and subsequently treated with the 0.19 mg fluocinlone acetonide (FAc) implant experienced rises in intraocular pressure and functional improvements similar to those in the FAME trials.
The Iluvien registry safety study (IRISS), examined the effectiveness of the FAc implant, which is a single injection that can last for up to 3 years, in 182 patients with DME and researchers presented the findings at the 2019 Annual Meeting of the Association for Research in Vision and Ophthalmology.
“In the pivotal trials on Anti-VEGF agents the results are really impressive, you gain visual acuity. But, when you look at real world data in DME, you see that patients do not gain but lose visual acuity when treated with Anti-VEGF,” said Ramin Khoramnia, FEBO, study author and associate professor of ophthalmology at the University of Heidelberg, Germany.​
In order to assess the safety and effectiveness of Iluvien as part of the 5-year IRISS study, investigators enrolled 209 eyes from 182 patients with DME to receive the FAc implant and monitored them for the next 3 years. Investigators determined the safety of the implant in terms of IOP events and their management, while effectiveness was measured in terms of changes in stable best-recorded visual acuity (BRVA) and the percentage of patients achieving 6/12 vision.
The mean age of patients was 65.7 years and the mean duration of DME at the start of the study was 4.55 years. Mean IOP was 14.9 mmHg at baseline and remained below 21 mmHg during the 3 years of follow-up. Authors noted that 87.6% of eyes that received the FAc implant were pseudophakic.
Investigators observed that 35.4% of eyes required topical IOP-lowering drops to control elevations in pressure and 9 eyes required IOP-lowering surgery. After 36 months of follow-up, investigators found that visual acuity was stable in 70.8% of eyes, 18.9% of eyes achieved 15 letters or more gained from baseline and 6/12 visual acuity was achieved in 31.1% of eyes.
Investigators noted that the rates of IOP-related events were similar in the both the IRISS study and FAME trials. FAME participants had higher rates of treatment emergent IOP-lowering medication (35.9% versus 35.4%), IOP-lowering surgery (5.3% versus 4.3%), and IOP increases 10 mmHG or more (31.1% versus 16.4%).
IRISS patients had higher rates of IOP greater than 30 mmHg (15.6% versus 14.8%) and both groups had the same rate of trabeculoplasty (1.9%).
The IRISS study had lower rates of visual acuity gains and slightly higher rates of patients with 15 or more letters lost than the FAME trial. In the FAME trial, 34% of eyes achieved visual acuity gains of 15 letters or more and 84% of eyes showed stable or improved visual acuity. FAME eyes had a slightly lower rate of loss of 15 letters or more compared to IRISS eyes (9.1% versus 9.4%).
Based on the results, investigators concluded that patients who receive the FAc implant in a real-world setting will have similar outcomes to those found within the FAME trials. Additionally, investigators noted that functional improvements seen within the IRISS study were in accordance with those observed in the FAME trials.
This study, titled “Real-World outcomes from the 3-year European Iluvien RegIstry Safety Study,” was presented as a poster at the 2019 Annual Meeting of the Association for Research in Vision and Ophthalmology.