Real-world data support the benefits of CONTINUOUS MICRODOSING™ Delivery

The USER Study provides valuable, real-world clinical insights on visual acuity (VA), edema, and safety before and after ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg implantation

  • At the time of the ILUVIEN Phase 3 clinical trials (FAME), there were no approved treatments for diabetic macular edema (DME); therefore, outcomes in patients after prior injectable therapies could not be assessed
  • In USER, treatments used before and/or after ILUVIEN included laser, intravitreal anti-VEGF, and steroids1
    • Despite prior treatment, at the time patients received ILUVIEN mean retinal thickness was > 350 microns

Limitations of the USER Study

  • Data are based on clinical practice, where the reporting of data is not standardized, and the data may not be as rigorous as in a clinical trial where the data collected are monitored
  • USER involved the collection of data up to 3 years prior to ILUVIEN (where available) and all available data post-ILUVIEN — Mean follow-up after ILUVIEN was 403 days, with 102 eyes followed up for 6 months, 92 for 12 months, and 50 for 18 months
  • Optical coherence tomography (OCT) data were only available for 120 eyes

The USER Study consisted of patients with persistent DME and the data confirmed:

  • Patients treated with ILUVIEN with good starting VA maintained VA and those with poor starting VA improved VA
  • 63% of eyes required no additional DME treatment throughout follow-up1
  • In the 42% of eyes that had a VA of ≥ 20/40 at the time of ILUVIEN treatment, VA was maintained with 87% fewer DME treatments on average
  • In the 20% of eyes that had a VA of < 20/100 at the time of ILUVIEN treatment, VA improved with a reduction in the number of DME treatments on average

DME treatment frequency before and after ILUVIEN treatment, entire populationa
(N=160 eyes)

aMean follow-up after ILUVIEN was 403 days, with 102 eyes followed up for 6 months, 92 for 12 months, and 88 for 15 months. The number of patients available for follow-up at each time point varied.
bP0.001 vs treatment frequency before ILUVIEN.
cP=0.026 vs treatment frequency before ILUVIEN.

USER data confirm the benefits of CONTINUOUS MICRODOSING™ Delivery on retinal edema

  • After treatment with ILUVIEN, patients in the USER Study had a decrease in retinal thickness on average1
  • After treatment with ILUVIEN, the proportion of eyes with “normal” CST (≤ 300 microns) increased over time1

USER data: Center subfield retinal thickness (CST), OCT population (N=120 eyes)

USER data: percentage of eyes with CST ≤ 300 microns, OCT population (N = 120 eyes)

The numbers in parentheses represent the number of eyes with data at those time points.
Phase 3clinical trials
Phase 3
clinical trials

The real-world safety and efficacy of ILUVIEN mirror
outcomes seen in the ILUVIEN Phase 3 clinical trials (FAME).

PATIENTcase study
PATIENT
case study

Individual patient cases illustrate the effects of
CONTINUOUS MICRODOSING™ Delivery on retinal stability.