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ANI Pharmaceuticals Announces FDA Approval for Expansion of ILUVIEN® Label
ILUVIEN now approved for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS) in addition to diabetic macular
About this update from Ani Pharmaceuticals, Inc.
[{"type":"text","content":"ILUVIEN now approved for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS) in addition to diabetic macular edema (DME)ANI plans to begin marketing ILUVIEN in the U.S. under the combined label later this year BAUDETTE, Minn., March 14, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded label for ILUVIEN (fluocinolone acetonide intravitreal implant) that includes an indication for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS). The approval also includes other updates to the label including to the Warnings and Precautions section. As previously announced, the Company plans to market ILUVIEN for chronic NIU-PS in addition to its current indication of diabetic macular edema (DME) in the U.S. ILUVIEN is already approved for both DME and NIU-PS outside the U.S., including in seventeen European countries. Nikhil Lalwani, President and CEO of ANI stated, “ILUVIEN’s expanded label and the strengthening of our partnership with long-standing ILUVIEN contract manufacturer, Seigfried, will enhance supply security and access for appropriate NIU-PS and DME patients in need.” 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. INDICATIONSILUVIEN is a corticosteroid 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. IMPORTANT SAFETY INFORMATIONCONTRAINDICATIONS 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.ILUVIEN is contraindicated in patients with glaucoma who have cup to disc ratios of greater than 0.8.ILUVIEN is cont...