On September 26, 2014, The US Food and Drug Administration approved ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg for the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure.1
ILUVIEN has also received marketing authorization approvals in Austria, Belgium, the Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, the Netherlands, Norway, Poland, Portugal, Spain, Sweden and the United Kingdom for the treatment of vision impairment associated with chronic diabetic macular edema (DME), considered insufficiently responsive to available therapies.
ILUVIEN is an intravitreal implant of fluocinolone acetonide and is the first DME treatment to deliver 36 months of continuous, low-dose corticosteroid with a single injection.1
Fluocinolone acetonide is a corticosteroid, which may play an important role in addressing the inflammatory process associated with DME. Corticosteroids have been shown to inhibit inflammatory responses to a variety of inciting agents. They inhibit edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation.1
ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg is indicated for the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure.
ILUVIEN® IMPORTANT SAFETY INFORMATION
- ILUVIEN is contraindicated in patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections and fungal diseases.
- ILUVIEN is contraindicated in patients with glaucoma who have cup to disc ratios of greater than 0.8
- ILUVIEN is contraindicated in patients with known hypersensitivity to any components of this product.
WARNINGS AND PRECAUTIONS
- Intravitreal injections, including those with ILUVIEN, have been associated with endophthalmitis, eye inflammation, increased intraocular pressure, and retinal detachments. Patients should be monitored following the intravitreal injection.
- Use of corticosteroids including ILUVIEN may produce posterior subcapsular cataracts, increased intraocular pressure and glaucoma. Use of corticosteroids may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses. Corticosteroids are not recommended to be used in patients with a history of ocular herpes simplex because of the potential for reactivation of the viral infection.
- Patients in whom the posterior capsule of the lens is absent or has a tear are at risk of implant migration into the anterior chamber.
- In controlled studies, the most common adverse reactions reported were cataract development (ILUVIEN 82%; sham 50%) and intraocular pressure elevation of ≥ 10 mm Hg (ILUVIEN 34%; sham 10%).