Fluocinolone Implant Real-World Experience Matches DME Trials

Laird Harrison

November 16, 2020

A fluocinolone acetonide implant (Iluvien) administered under real-world circumstances works just as well for diabetic macular edema (DME) as it did in clinical trials, a new study suggests.

Patients who had not benefited from anti-vascular endothelial growth factor (anti-VEGF) intravitreal injections experienced improved vision and sustained it for 3 years.

The results show the advantages of an implant over monthly injections, said Ramin Khoramnia, MD, PhD, from the University Eye Clinic in Heidelberg, Germany. With this approach, "all these problems of adherence and compliance are really not an issue," he told Medscape Medical News.

Khoramnia presented the finding from the Iluvien Registry Safety Study at the virtual American Academy of Ophthalmology (AAO) 2020 annual meeting.

Anti-VEGF injections work well in most DME patients, but not in all. And real-world studies of these treatments suggest that results fall far short of those obtained in clinical trials.

Steroids including dexamethasone and fluocinolone, both available in implants, offer an alternative.

The fluocinolone implant remains active for three years. To see how well it has performed in real life compared to the pivotal FAME trials, Khoramnia and his colleagues followed 343 eyes in 295 patients at 29 sites in the United Kingdom, nine in Germany, and three in Portugal.

The patients had a mean age of 66.3 years and had suffered from DME for a mean of 4.9 years. At baseline, their mean visual acuity was 52.2 letters.

Almost all the patients had received anti-VEGF or laser treatment without adequate success.

After getting their fluocinolone implants, 48.7% of patients received other DME treatments. They received these treatments on average about a year after getting the implants, and over the 36 months of the study, they received a mean of 7.4 supplementary treatments, with 11.1% receiving an additional fluocinolone implant.

At baseline, 18.6% had 20/40 vision, but this proportion grew to about one third when the patients received the implants and then remained constant. It was 32% at the end of 36 months. Those with better vision had no significant changes over that time. And overall, 71% of eyes had stable or improving visual acuity at 36 months.

Despite the efficacy of the fluocinolone implant, Khoramnia said it can cause cataracts and raise intraocular pressure (IOP). "You must be aware that if you are using the Iluvien implant, you can be pretty sure that your patient will develop cataract at the end of the day," Khoramnia said. That's why it is recommended as a second-line treatment where anti-VEGF injections have failed.

While he did not report on the rate of cataract in these patients, Khoramnia noted that only 13.1% were phakic at baseline and it is likely that they all needed cataract surgery over the course of 36 months.

At baseline, the patients' mean intraocular pressure (IOP) was 15.6 mm Hg, though 8.2% of patients had IOP levels greater than 21 mm Hg. Mean IOP stayed under 21 mm Hg throughout the 36 months, but 16.6% of patients had IOP increases over 30 mm Hg, 39.9% needed IOP-lowering medication, 2.3% had trabeculoplasty, and 3.2% had incisional IOP-lowering surgery.

These results are similar to those obtained in the FAME trials, said Khoramnia, a sharp contrast to the failure of anti-VEGF drugs to match their performance in clinical trials. The new finding suggests that a similar implant for delivering anti-VEGF drugs might be more successful.

In his own practice, Khoramnia uses both the fluocinolone implant and the dexamethasone implant (Ozurdex) in patients who don't benefit from anti-VEGF therapy. But the dexamethasone implant lasts only 2-3 months. "When you have a patient where you think a shorter treatment is enough, the dexamethasone implant is interesting," he said.

The implants may be particularly useful in patients with diabetes who have had trouble adhering to recommendations for controlling their blood sugar as well as following a regular regimen of intravitreal injections, said Kourous Rezaei, MD, from Rush University Medical College in Chicago, Illinois.

He likes to start these patients with the dexamethasone implant to see if it works before placing the longer-term, and more expensive, fluocinolone implant.

"If anti-VEGF injections fail then patients receive these long-lasting treatments like Ozurdex as a second line of treatment," he told Medscape Medical News. "If they respond well to Ozurdex, then they become a good candidate for Iluvien because it's a 3-year therapy."

American Academy of Ophthalmology (AAO) 2020 annual meeting: Abstract PA053.01. Presented November 13, 2020.

Laird Harrison writes about science, health and culture. His work has appeared in national magazines, in newspapers, on public radio and on websites. He is at work on a novel about alternate realities in physics. Harrison teaches writing at the Writers GrottoVisit him at  lairdharrison.com or follow him on  Twitter: @LairdH .

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