Skip to content
ClinCalc Pro
Menu
Calculators Drugs Pathways AI Dx Donate Get the App
Corticosteroid — Intravitreal Non-biodegradable Implant (36 months) Pregnancy: Avoid as a precautionary measure. Verbatim UK SPC 4.6: 'There are limited data from the use of intravitreally administered fluocinolone acetonide in pregnant women. Animal studies are insufficient with respect to the reproductive toxicity of intravitreally administered fluocinolone acetonide. Although fluocinolone acetonide is undetectable in the systemic circulation after local, intraocular treatment, fluocinolone is nonetheless a potent corticosteroid and even very low levels of systemic exposure may present some risk to the developing foetus. As a precautionary measure it is preferable to avoid the use of ILUVIEN during pregnancy.' Breast-feeding: 'Systemically administered fluocinolone acetonide is excreted in breast milk. Although the systemic exposure of the breast-feeding woman to intravitreally administered fluocinolone acetonide is expected to be very low, a decision must be made whether to discontinue breast-feeding or to abstain from ILUVIEN therapy, taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.' Fertility: 'There are no fertility data available. However, effects on either male or female fertility are unlikely since the systemic exposure to fluocinolone acetonide following intravitreal administration is very low.'

Fluocinolone Acetonide Intravitreal Implant 0.19 mg

Brand names: Iluvien

This is a non-bioerodible intravitreal implant releasing the corticosteroid fluocinolone acetonide over an extended period, used for chronic diabetic macular oedema and certain cases of non-infectious posterior uveitis.

Adult dose

Dose: Diabetic macular oedema (the page's primary indication) — one ILUVIEN 190 microgram intravitreal implant in the affected eye. The same one-implant dose applies to the label's second licensed use, prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye. Administration in both eyes concurrently is not recommended.
Route: Intravitreal — FOR INTRAVITREAL USE ONLY. Administered by a qualified healthcare professional experienced in intravitreal injections, under controlled aseptic conditions (sterile gloves, sterile drape, sterile eyelid speculum or equivalent), with adequate anaesthesia and a broad-spectrum microbicide given prior to injection. Optimal placement of the implant is inferior to the optic disc and posterior to the equator of the eye, measured 4 millimeters inferotemporal from the limbus.
Frequency: A single implant, which releases fluocinolone acetonide for up to 36 months. Diabetic macular oedema only: 'An additional implant may be administered after 12 months if the patient experiences decreased vision or an increase in retinal thickness secondary to recurrent or worsening diabetic macular oedema.' Retreatments should not be administered unless the potential benefits outweigh the risks. Non-infectious posterior uveitis: 'There are no data available to support the retreatment of patients with an additional implant when used for the prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye.'
SOURCE IDENTITY — EXACT MATCH. The fetched product is 'ILUVIEN 190 micrograms intravitreal implant in applicator' (UK SPC via eMC, product 3061). This page's single named brand is Iluvien, its stated strength is 0.19 mg (= the 190 micrograms in the product title), its stated route is 'Intravitreal implant', and its stated category is a non-biodegradable 36-month corticosteroid implant. Drug, brand, strength, route, dosage form and duration all match the fetched product, so this is the page's own product and not a near-miss. || VERBATIM UK SPC 4.2 Posology: 'The recommended dose is one ILUVIEN implant in the affected eye. Administration in both eyes concurrently is not recommended (see Section 4.4). Each ILUVIEN implant releases fluocinolone acetonide for up to 36 months. Diabetic Macular Oedema An additional implant may be administered after 12 months if the patient experiences decreased vision or an increase in retinal thickness secondary to recurrent or worsening diabetic macular oedema (see Section 5.1). Retreatments should not be administered unless the potential benefits outweigh the risks. Only patients who have been insufficiently responsive to prior treatment with laser photocoagulation or other available therapies for diabetic macular oedema should be treated with ILUVIEN.' || PATIENT SELECTION IN DIABETIC MACULAR OEDEMA is part of the dose: only patients insufficiently responsive to prior laser photocoagulation or other available therapies should be treated. || SCOPE: the fetched 4.2 is COMPLETE in this bundle (no truncation marker) and covers both licensed indications, so no licensed regimen has been omitted. Sections 4.4 and 4.8 DO carry the source-fetch truncation marker — the warnings text stops mid-sentence on post-vitrectomy clearance and the adverse-reaction table stops part-way through the 'Eye disorders / Common' row, so the safety lists below are partial and must not be read as complete. || WHY maxDose IS DELIBERATELY UNPOPULATED: the SPC states no maximum dose. It gives one implant per affected eye per administration and, in diabetic macular oedema only, permits one additional implant after 12 months. || SPECIAL POPULATIONS, verbatim: 'No dosage adjustments are necessary in elderly patients, or those with renal or hepatic impairment.' || POST-INJECTION SEQUENCE, verbatim: 'Following the procedure, patients should be monitored for potential complications such as endophthalmitis, increased intraocular pressure, retinal detachments, and vitreous haemorrhages or detachments and ocular hypotony (observed up to 8 days post treatment). Biomicroscopy with tonometry should be performed between two and seven days after the implant injection. Thereafter it is recommended that patients are monitored at least quarterly for potential complications, due to the extended duration of release of fluocinolone acetonide, of approximately 36 months.' || The implant is made of polyimide and 'is therefore expected to remain inert inside the eye'; the long-term safety implications of retention of the non-bioerodable implant inside the eye are not known. In the event of IOP increases that do not respond to IOP-lowering medications or procedures, the ILUVIEN implant can be removed by vitrectomy.

Paediatric dose

NO PAEDIATRIC DOSE — the label gives none, and none has been invented or scaled from the adult figure. Verbatim UK SPC 4.2, Paediatric population: 'There is no relevant use of intravitreally administered fluocinolone acetonide in the paediatric population in diabetic macular oedema (DMO). The safety and efficacy in uveitis in the paediatric population has not been established.'

Dose adjustments

Renal

None. Verbatim UK SPC 4.2, Special populations: 'No dosage adjustments are necessary in elderly patients, or those with renal or hepatic impairment.'

Hepatic

None. Verbatim UK SPC 4.2, Special populations: 'No dosage adjustments are necessary in elderly patients, or those with renal or hepatic impairment.'

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Pre-existing glaucoma — 'An intravitreal implant with ILUVIEN is contraindicated in the presence of pre-existing glaucoma'
  • Active or suspected ocular or periocular infection, including most viral diseases of the cornea and conjunctiva: active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections and fungal diseases
  • Infectious uveitis
  • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
  • Not a contraindication but an explicit recommendation (sections 4.2 and 4.4): an implant should not be administered to both eyes at the same visit, and concurrent treatment of both eyes is not recommended until the patient's systemic and ocular response to the first implant is known

Side effects

  • Very common (eye disorders): cataract; increased intraocular pressure
  • Common (eye disorders): glaucoma, retinal detachment, optic disc haemorrhage, vitreous haemorrhage — the tabulated list is cut off at the source-fetch limit part-way through this row, so the remainder of the eye-disorder reactions was NOT retrieved
  • Uncommon: endophthalmitis; headache
  • In the Phase 3 diabetic macular oedema (FAME) studies, 38.4% of subjects treated with ILUVIEN required IOP-lowering medication and 4.8% required IOP-lowering surgeries
  • Section 4.4 records that 80% of phakic subjects treated with fluocinolone acetonide underwent cataract surgery in the FAME studies; phakic patients should be closely monitored for signs of cataract after treatment
  • Two cases of endophthalmitis were reported in ILUVIEN-treated subjects in the Phase 3 studies — 'an incidence rate of 0.2% (2 cases divided by 1,022 injections)'
  • Conjunctival haemorrhage was slightly more frequent in subjects treated with ILUVIEN concomitantly or within 30 days of cessation of anti-coagulant or anti-platelet medications (0.5% sham versus 2.7% ILUVIEN)
  • Intravitreal injection procedure risks stated in section 4.4: endophthalmitis, increase or decrease in intraocular pressure, retinal detachment, and vitreous haemorrhage or detachment. Ocular hypotony has been observed up to 8 days post treatment
  • Visual disturbance may be reported with corticosteroid use; possible causes include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR)
  • ⚠️ INCOMPLETE LIST: section 4.8 carries the source-fetch truncation marker, so the full frequency table (and any non-ocular reactions listed after it) was not retrieved

Monitoring

  • Instruct patients to report without delay any symptoms suggestive of endophthalmitis
  • Examine within two to eight days following the injection — 'Patient monitoring within two to eight days following the injection may permit early identification and treatment of ocular infection, decrease or increase in intraocular pressure or other complication'
  • Perform biomicroscopy with tonometry between two and seven days after the implant injection
  • Monitor intraocular pressure at least quarterly thereafter, for the approximately 36-month duration of fluocinolone acetonide release
  • Immediately after injection, perform indirect ophthalmoscopy to verify implant placement, adequate central retinal artery perfusion and absence of other complications, including a check for perfusion of the optic nerve head; immediate IOP measurement may be performed at the discretion of the healthcare professional
  • Use with caution in patients with high baseline IOP and monitor IOP closely; where IOP increases do not respond to IOP-lowering medications or procedures, the implant can be removed by vitrectomy
  • Monitor phakic patients closely for signs of cataract after treatment
  • Refer any patient presenting with blurred vision or other visual disturbance for ophthalmological evaluation of possible causes including cataract, glaucoma or central serous chorioretinopathy

Clinical monograph

How it works

The implant provides sustained low-dose intraocular delivery of fluocinolone acetonide, a glucocorticoid that suppresses inflammatory mediators, reduces vascular permeability and stabilises the blood-retinal barrier, decreasing macular oedema.

Prescribing in practice

  • Sustained intraocular corticosteroid exposure commonly causes raised intraocular pressure and cataract progression, so steroid-induced glaucoma and lens changes must be monitored throughout the implant's lifespan.
  • It is contraindicated in active or suspected ocular or periocular infection, including most viral, fungal and mycobacterial eye disease.
  • Patient selection typically favours pseudophakic eyes or those already considered for cataract surgery, given the high likelihood of cataract formation.

Monitoring

Monitor intraocular pressure regularly and for prolonged periods after implantation, along with lens status and signs of infection, because steroid response can be delayed.

Counselling the patient

  • Expect ongoing eye-pressure checks, as the steroid can raise pressure and may require additional drops.
  • Development or worsening of cataract is likely over time and may eventually need surgery.
  • Report any new eye pain, redness or visual changes promptly.

Evidence & guidelines

The FAME studies supported sustained-release fluocinolone acetonide implants for chronic diabetic macular oedema, and NICE has appraised this implant within defined patient groups.

Reference: NICE TA301; FAME Trial (Ophthalmology 2011); SPC Iluvien; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

Calculators
Pathways