ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg safety profile

The most commonly reported ocular adverse reactions were cataract, myodesopsia, eye pain, and conjunctival hemorrhage.

Review Study Design

FAME data: Most commonly reported ocular adverse reactions in the pivotal ILUVIEN FAME studies1

aIncludes cataract, cataract nuclear, cataract subcapsular, cataract cortical, and cataract diabetic in patients who were phakic at baseline. Among these patients, 80% of ILUVIEN subjects vs 27% of sham-controlled subjects underwent cataract surgery.b235 of the 375 ILUVIEN subjects were phakic at baseline; 121 of 185 sham-controlled subjects were phakic at baseline.

Summary of IOP elevation from the ILUVIEN Phase 3 clinical trials1

  • 34% of ILUVIEN patients had IOP elevation ≥ 10 mm Hg from baseline, as compared to 10% in the sham injection group
  • 20% of ILUVIEN patients had IOP elevation ≥ 30 mm Hg from baseline, as compared to 4% in the sham injection group

In patients treated per label, ILUVIEN had a predictable intraocular pressure (IOP) profile

In the pivotal ILUVIEN FAME studies, no patient treated after prior ophthalmic steroid injection required surgical intervention for elevated IOP3

The FDA indication differs from the FAME study inclusion criteria due to the requirement for “a prior course of corticosteroid without a clinically significant rise in IOP.” Seventy-two patients in the pivotal ILUVIEN FAME studies previously had an ophthalmic steroid injection and did not fall into the exclusion criteria “patients with a history of uncontrolled IOP elevation with steroid use that did not respond to topical therapy”3

FAME study data: Impact of prior ophthalmic corticosteroid
injection on IOP-lowering surgery3

The 18 patients requiring surgical intervention for elevated IOP would not have met the US label requirement.
Real-worldSafety
Real-world
Safety

Real-world data from the USER Study confirm the
predictable IOP profile of ILUVIEN, when used per label.

PATIENTcase study
PATIENT
case study

See how Dr. Kitchens managed a patient with
clinically non-significant IOP elevations.