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Product Overview

At Alimera Sciences, we are dedicated to developing innovative, vision-improving treatments for diseases of the retina. Our commitment to retina specialists and their patients is manifest in our development portfolio, studying compounds to treat early- and late-stage diseases such as diabetic macular edema, wet and dry age-related macular degeneration (AMD) and retinal vein occlusion (RVO).

Today, our primary focus is on ILUVIEN®(fluocinolone acetonide intravitreal implant) 0.19 mg.  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 has received FDA approval in the United States 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.Learn More

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.

In addition to activities related to the development of ILUVIEN, we are researching the safety and effectiveness of NADPH (Nicotinamide Adenine Dinucleotide Phosphate) oxidase inhibitors. Learn more >>

 

INDICATION

ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg is indicated for the treatment of diabetic macular edema 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

CONTRAINDICATIONS

  • 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 have been associated with endophthalmitis, eye inflammation, increased intraocular pressure, and retinal detachments. Patients should be monitored following the intravitreal injection.
  • Use of corticosteroids may produce posterior subcapsular cataracts, increased intraocular pressure, glaucoma, and 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.

 

ADVERSE REACTIONS

  • In controlled studies, the most common adverse reactions reported were cataract development and increases in intraocular pressure.