Product image of Iluvien (Fluocinolone Acetonide) supplied by GNH India

Iluvien

Active Ingredient:
Fluocinolone Acetonide
Origin:
EU

Iluvien (Fluocinolone Acetonide)

Fluocinolone Acetonide, the active ingredient in Iluvien, is a corticosteroid presented as a 0.19 mg sustained‑release intravitreal implant for intravitreal use. It is indicated for the treatment of diabetic macular edema in adult patients.

GNH India supplies Iluvien as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, ophthalmology clinics and procurement teams worldwide, providing reliable access to this specialty ophthalmic product. The company adheres to stringent quality standards and supports regulatory compliance in all target markets. Our distribution network ensures timely delivery and appropriate storage conditions.

Manufacturer / TM Owner

Alimera Sciences Europe Limited

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Indications & Clinical Uses

  • Iluvien (fluocinolone acetonide) is used to manage diabetic macular edema, a chronic retinal condition.
  • Diabetic macular edema: reduces retinal thickness, decreases fluid accumulation, and helps stabilise or improve visual acuity in affected eyes.
  • Persistent diabetic macular edema after prior therapy: delivers continuous low‑dose corticosteroid directly to the vitreous, providing up to 36 months of treatment without repeated injections.
  • Chronic diabetic macular edema in adults: maintains macular structural integrity, limits disease progression, and reduces the need for additional pharmacologic interventions.

How It Works

  • Fluocinolone acetonide binds to glucocorticoid receptors in ocular tissues, altering gene transcription to suppress inflammatory cytokine production, reduce vascular permeability, and limit leukocyte infiltration. This anti‑inflammatory action diminishes retinal fluid buildup and stabilises the macular architecture in diabetic macular edema.

Side Effects

Iluvien may be associated with ocular adverse reactions, which are categorised by frequency and severity.

Common Side Effects

  • Increased intraocular pressure
  • Cataract formation or progression
  • Ocular pain or discomfort after implantation
  • Vitreous floaters or visual disturbances
  • Conjunctival haemorrhage
  • Blurred vision

Serious or Rare Side Effects

  • Endophthalmitis or severe intraocular infection
  • Retinal detachment or tear
  • Persistent IOP elevation requiring surgical intervention
  • Implant migration or dislocation
  • Severe ocular inflammation or uveitis
  • Optic nerve damage or vision loss

Precautions & Warnings

  • Prior to Iluvien implantation, clinicians should evaluate patient suitability and monitor for known risks.
  • Glaucoma risk assessment: measure baseline intraocular pressure and visual field before implantation.
  • Cataract monitoring: observe lens opacity development in phakic eyes during follow‑up.
  • Infection control: avoid implantation in eyes with active infection or inflammation.
  • Intraocular pressure monitoring: schedule regular IOP checks after the procedure to detect elevation early.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Iluvien can interact with other ocular or systemic agents, influencing safety or efficacy.

Major Interactions (Avoid)

  • Systemic corticosteroids: additive risk of intraocular pressure rise and cataract formation.
  • Antifungal azoles (e.g., ketoconazole): may increase local steroid concentration, heightening IOP risk.
  • Intravitreal anti‑VEGF agents administered concurrently: may alter implant positioning or increase inflammation.

Moderate Interactions (Monitor Closely)

  • Topical NSAID eye drops: monitor for delayed corneal healing.
  • Other intravitreal drugs (e.g., steroids, antibiotics): stagger administration to avoid overlapping toxicity.
  • Beta‑blocker eye drops: observe for potential pupil size changes.

Frequently Asked Questions

Iluvien is a sustained‑release intravitreal implant containing fluocinolone acetonide, prescribed for the treatment of diabetic macular edema in adult patients. It delivers a low dose of corticosteroid directly to the vitreous cavity, helping to reduce retinal swelling and stabilize vision over an extended period.

Fluocinolone acetonide binds to glucocorticoid receptors in ocular tissues, modulating gene transcription. This reduces production of inflammatory cytokines, decreases vascular permeability, and limits leukocyte infiltration, thereby lowering retinal fluid accumulation and preventing further damage in diabetic macular edema.

The dose of Iluvien is determined by the prescribing ophthalmologist. The implant contains a fixed 0.19 mg of fluocinolone acetonide and is inserted as a single intravitreal device; the clinician decides whether it is appropriate based on the patient’s disease status and prior treatments.

The safety of Iluvien in pregnancy or lactation has not been established, and the product is classified as pregnancy category unknown. It should only be used if the potential benefit justifies the potential risk, and clinicians should discuss uncertainties with the patient.

To request Iluvien, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any cold‑chain requirements) and necessary import documentation.

Compared with repeated intravitreal anti‑VEGF injections, Iluvien offers a sustained‑release corticosteroid platform that can last up to three years, reducing injection frequency. However, it carries a higher risk of intraocular pressure elevation and cataract formation, so patient selection and monitoring differ from anti‑VEGF therapies.

Iluvien must be stored at 2–8 °C in its original packaging, protected from light, and must not be frozen or shaken. Prior to implantation, the device should be allowed to reach room temperature if required by the surgical protocol, and handled only by trained personnel in a sterile environment.

Iluvien is implanted by an ophthalmic surgeon using a specialized intravitreal delivery system. The implant is placed through the pars plana into the vitreous cavity, where it slowly releases fluocinolone acetonide over several years. The procedure is performed under aseptic conditions, typically in an operating‑room setting.

The most serious adverse events include sustained elevation of intraocular pressure that may require surgical intervention, development of cataract necessitating extraction, and rare but vision‑threatening complications such as endophthalmitis, retinal detachment, or implant migration. Prompt monitoring and early management are essential to mitigate these risks.

Iluvien is contraindicated in eyes with active ocular infection, uncontrolled glaucoma, or known hypersensitivity to fluocinolone acetonide or any component of the implant. Patients with a history of steroid‑induced intraocular pressure spikes or those unable to attend regular follow‑up should be evaluated carefully before implantation.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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