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Corticosteroid — Intravitreal Non-biodegradable Implant (36 months) Pregnancy: Avoid — corticosteroids affect fetal development; 36-month release means prolonged exposure

Fluocinolone Acetonide Intravitreal Implant 0.19 mg

Brand names: Iluvien

Adult dose

Dose: 0.19 mg intravitreal implant (single 25-gauge injectable implant)
Route: Intravitreal implant
Frequency: Single implant providing sustained release for 36 months
Max: One implant per eye per 36-month period
Non-biodegradable polyimide tube — releases 0.2 mcg fluocinolone acetonide per day for 36 months. Licensed for chronic DME insufficiently responsive to laser photocoagulation. Implant remains in vitreous permanently (not biodegradable) — visible on funduscopy/USS. Usually restricted to pseudophakic eyes.

Paediatric dose

Route:
Not licensed for paediatric use

Dose adjustments

Renal

No systemic adjustment — intravitreal

Hepatic

No adjustment

Clinical pearls

  • FAME trial (Ophthalmology 2011): fluocinolone acetonide 0.19 mg implant significantly improved visual acuity in chronic DME over 36 months — patients with diabetes >15 years showed greatest benefit
  • 36-month sustained release: single injection providing 3 years of continuous drug delivery — substantial treatment burden reduction for chronic DME patients who had been receiving monthly anti-VEGF injections; cost-effective modelling supports use
  • Non-biodegradable — permanent implant: unlike Ozurdex, Iluvien is permanent and visible on fundoscopy; patients must be informed; the implant can migrate (rare) and occasionally crosses through a previous surgical wound
  • IOP monitoring over 36 months: IOP elevation is spread over the full 3-year release period — mandatory IOP monitoring at each clinic visit; establish baseline IOP and family history of glaucoma before implant
  • NICE TA301: fluocinolone acetonide implant (Iluvien) approved for chronic DME in pseudophakic eyes (or where anti-VEGF treatment is contraindicated) — must have failed other treatments first

Contraindications

  • Active ocular or periocular infection
  • Glaucoma requiring >1 IOP-lowering medication
  • Phakic eyes (cataract is universal; reserved for pseudophakic in practice)
  • Hypersensitivity to fluocinolone acetonide

Side effects

  • Cataract — 100% in phakic eyes over 36 months; implant is only used in pseudophakic eyes in UK practice
  • IOP elevation — 38% at some time point; 33% requiring IOP-lowering medication
  • Glaucoma — ~5% may require surgical intervention; 3-year IOP monitoring mandatory
  • Conjunctival haemorrhage
  • Vitreous floaters

Interactions

  • No clinically significant systemic drug interactions

Monitoring

  • IOP at each visit (every 3 months minimum) for 36 months
  • Visual acuity
  • OCT — central retinal thickness
  • Glaucoma assessment — optic disc, visual fields annually

Reference: BNFc; BNF 90; NICE TA301; FAME Trial (Ophthalmology 2011); SPC Iluvien. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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