FDA approves expanded label for fluocinolone acetonide intravitreal implant

Author(s):

This treatment is already approved for both diabetic macular edema (DME) and NIU-PS outside the US, including in 17 European countries.

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The US Food and Drug Administration (FDA) has approved an expanded label for fluocinolone acetonide intravitreal implant (ILUVIEN) that includes an indication for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS). In addition to the expansion of this label, the approval includes updates to the label including to the Warnings and Precautions section. This treatment is already approved for both diabetic macular edema (DME) and NIU-PS outside the US, including in 17 European countries.

ANI previously announced that it extended its supply agreement for ILUVIEN with a subsidiary of Siegfried Holding AG (Seigfried) through 2029. Siegfried and ANI also agreed to upgrade equipment on the existing manufacturing line and significantly expand capacity.

Indications

ILUVIEN is a corticosteroid indicated for:

the treatment of 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 NIU-PS of the eye.

Contraindications

ILUVIEN is contraindicated in patients

with active or suspected ocular or periocular infections including most viral disease of the cornea and conjunctiva including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections and fungal diseases;
with glaucoma who have cup to disc ratios of greater than 0.8;
with known hypersensitivity to any components of this product.
Additional information on safety information and adverse events can be found in the company press release.