Khoramnia R, et al. Real-life long-term outcomes for patients treated with the 0.19 mg fluocinolone acetonide (FAc; ILUVIEN) intravitreal implant for DME: Three-year follow-up from the RegIstry Safety Study (IRISS). Presented at: Association for Research in Vision and Ophthalmology annual meeting; June 12, 2020 (virtual meeting).
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Real-world study shows long-term safety, efficacy of Iluvien in DME
Khoramnia R, et al. Real-life long-term outcomes for patients treated with the 0.19 mg fluocinolone acetonide (FAc; ILUVIEN) intravitreal implant for DME: Three-year follow-up from the RegIstry Safety Study (IRISS). Presented at: Association for Research in Vision and Ophthalmology annual meeting; June 12, 2020 (virtual meeting).
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Real-world long-term study outcomes showed sustained safety and efficacy of Iluvien in patients with diabetic macular edema.
“The data also showed that IOP and VA outcomes were very similar to those reported in the pivotal FAME trials. It should be noted that real-world studies, particularly in the treatment of DME, very rarely confirmed the good outcomes of randomized clinical trials,” Ramin Khoramnia, MD, said at the virtual Association for Research in Vision and Ophthalmology meeting.
The Iluvien Registry Safety Study is an ongoing open-label observational study, recruiting patients from 29 sites in the U.K., nine in Germany and three in Portugal. It is designed to collect real-world data on the safety and effectiveness of Iluvien (fluocinolone acetonide intravitreal implant 0.19 mg, Alimera Sciences) implanted in patients with persistent DME insufficiently responsive to other therapies.
Three-year data were available for 343 eyes of 295 patients with long-standing DME, with an average of almost 5 years. Most were pseudophakic, and nearly all had received previous macular laser or intravitreal therapy.
“After implantation of Iluvien, 50% of the eyes did not receive supplementary treatment. This fact is especially interesting because all other options had failed before. Re-treatment with a second Iluvien implant was given in a small number of cases (11%), on average 2 years after the first,” Khoramnia said.
About 40% of the eyes had elevated IOP, which was well managed with IOP-lowering eye drops and remained stable over the study period. Only a small number of cases required surgery.
At baseline, 18% of patients had driving vision of 20/40, which increased to 32% at 12 to 36 months.
“In 71% of the eyes, VA remained stable or improved. Eyes with a starting VA of 20/40 or better sustained this good vision through to month 36,” Khoramnia said.
These real-life outcomes confirm the long-term safety and effectiveness of the implant in the treatment of DME after 3 years, he said.
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