Iluvien: intravitreal corticosteroid implant for diabetic macular oedema

Alimera has launched an intravitreal implant containing fluocinolone acetonide (Iluvien) to treat visual impairment caused by chronic diabetic macular oedema (DMO) that has not adequately responded to standard therapies.

Following intravitreal injection using the pre-loaded device, patients treated with Iluvien must be monitored for raised intraocular pressure, vitreous haemorrhage and vitreous or retinal detachment.
Following intravitreal injection using the pre-loaded device, patients treated with Iluvien must be monitored for raised intraocular pressure, vitreous haemorrhage and vitreous or retinal detachment.

PHARMACOLOGY

Fluocinolone acetonide is a corticosteroid. In addition to inhibiting the inflammatory response through the induction of phospholipase A inhibitory proteins (lipocortins), corticosteroids reduce levels of vascular endothelial growth factor, a protein that increases vascular permeability and causes oedema.1

CLINICAL STUDIES

In two double-blind studies, patients with DMO who had previously undergone laser photocoagulation were randomised to receive intravitreal sham injection (n=185), low-dose fluocinolone acetonide intravitreal implant (0.2 microgram/day, n=375) or high-dose implant (0.5 microgram/day, n=393). An increase of ≥15 letters in best corrected visual acuity (BCVA) at month 24 was the primary endpoint.2

Improved visual acuity

A significantly higher percentage of fluocinolone-treated patients met the primary endpoint compared with sham: 28.7% (low-dose) and 28.6% (high-dose) vs 16.2% (p=0.002 for both). The mean improvement in BCVA letter score between baseline and month 24 was 4.4 in the low-dose arm and 5.4 in the high-dose arm compared with 1.7 in the control arm (p=0.02 and p=0.016, respectively).2

When efficacy was assessed as a function of disease duration, patients with chronic DMO (≥3 years) had a significant beneficial response to treatment whilst those with DMO of a shorter duration did not show any benefit over control.1

Cataracts and raised IOP

The development of cataracts requiring surgery was more frequent in both implant groups than in the sham group, as was the development of raised intraocular pressure requiring incisional surgery (3.7% and 7.6% in the low- and high-dose implant groups compared with 0.5% in the sham group).2

References:

  1. Iluvien Summary of Product Characteristics, September 2012.
  2. Campochiaro PA et al. Ophthalmology 2011; 118: 626–35.

View Iluvien drug record

Further information: Alimera Sciences

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