ANI Pharmaceuticals received FDA approval for an expanded label for ILUVIEN, adding chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS) to its existing indication for diabetic macular edema (DME). The company plans to launch ILUVIEN in the U.S. with the combined label later this year. This approval also incorporates updates to the product’s Warnings and Precautions.
This expanded indication represents a significant advancement in treatment options for patients suffering from NIU-PS, a debilitating condition that can lead to vision loss. The availability of ILUVIEN for NIU-PS provides physicians with a much-needed sustained-release corticosteroid option, potentially reducing the frequency of injections and improving patient compliance. This also strengthens ANI’s position in the ophthalmic market, offering a treatment for two distinct conditions with a single product. Furthermore, the recently extended and expanded manufacturing agreement with Siegfried through 2029 should ensure a reliable supply of ILUVIEN to meet the anticipated increase in demand.
ILUVIEN is an intravitreal implant delivering fluocinolone acetonide, a corticosteroid. Key safety information includes contraindications for patients with active or suspected ocular infections, glaucoma with high cup-to-disc ratios, and hypersensitivity to the product’s components. Warnings and precautions include potential for increased intraocular pressure, cataract development, delayed corneal wound healing, and secondary ocular infections. Common adverse reactions for DME patients include cataracts, myodesopsia, and eye pain. For NIU-PS patients, common adverse reactions include cataracts, reduced visual acuity, macular edema, and uveitis.
This label expansion positions ILUVIEN for growth within the ophthalmic pharmaceuticals market, providing a valuable new therapeutic option for NIU-PS patients while solidifying ANI’s position as a provider of treatments for serious eye conditions. The company’s enhanced manufacturing capabilities should support increasing demand and contribute to long-term market success.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
