Iluvien FDA Approval History
Last updated by Judith Stewart, BPharm on March 14, 2025.
FDA Approved: Yes (First approved September 26, 2014)
Brand name: Iluvien
Generic name: fluocinolone acetonide
Dosage form: Intravitreal Implant
Company: Alimera Sciences, Inc.
Treatment for: Diabetic Macular Edema, Uveitis, Posterior
Iluvien (fluocinolone acetonide) is a corticosteroid implant for the treatment of diabetic macular edema and posterior uveitis.
- Iluvien 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.
- the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. - Iluvien is administered by intravitreal injection under aseptic conditions.
- Warnings and precautions associated with Iluvien include intravitreal injection-related effects (endophthalmitis, eye inflammation, increased intraocular pressure, and retinal detachment), increased intraocular pressure, delayed healing after cataract surgery, corneal and scleral melting, infections (bacterial, viral and fungal), and implant migration.
- Common adverse reactions include cataract development and increases in intraocular pressure.
Development timeline for Iluvien
Further information
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