ANI Pharmaceuticals Announces FDA Approval for Expansion of ILUVIEN® Label

Core Viewpoint - ANI Pharmaceuticals has received FDA approval for an expanded label for ILUVIEN, which now includes treatment for chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS) in addition to its existing indication for diabetic macular edema (DME) [1][4] Company Developments - The company plans to market ILUVIEN for chronic NIU-PS alongside DME in the U.S. later this year [4] - ANI has extended its supply agreement with Siegfried Holding AG for ILUVIEN through 2029, which includes upgrades to manufacturing equipment and significant capacity expansion [2] Product Indications - ILUVIEN is indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye and diabetic macular edema [3][5] Safety Information - ILUVIEN has contraindications for patients with active or suspected ocular infections, glaucoma with cup to disc ratios greater than 0.8, and known hypersensitivity to any components of the product [5] - Adverse reactions reported in clinical trials include cataracts (82% for DME), increased intraocular pressure (34% for DME), and various ocular and non-ocular reactions [6][7] Clinical Trial Data - In trials for DME, 34% of ILUVIEN patients experienced an increase in intraocular pressure of 10 mm Hg or more, compared to 10% of sham patients [6] - For chronic NIU-PS, ocular adverse reactions included cataract (56%), reduced visual acuity (15%), and macular edema (11%) [7][8] Company Overview - ANI Pharmaceuticals is a diversified biopharmaceutical company focused on developing, manufacturing, and commercializing innovative therapeutics across various therapeutic areas, including ophthalmology [12]