Iluvien Earns FDA Approval for Expansion to Treat Chronic Posterior Uveitis

ANI Pharmaceuticals announced that they the FDA has approved an expanded label for Iluvien to include treatment of chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS). 

“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,” Nikhil Lalwani, President and CEO of ANI, said in a recent press release.

Iluvien is a corticosteroid currently used to treatment diabetic macular edema (DME) in patients who have previously trialed corticosteroids and did not experience a clinically significant rise in IOP. It has already been approved for NIU-PS in 17 European countries. The company announced they will begin marketing under the new combined label later this year. 

The approval comes with additional updates to the label under warnings and precautions. These include intravitreal injection-related effects, intraocular pressure rise, cataract formation, intraocular infection, and risk of implant migration. Iluvien is contraindicated in patients with active ocular infections and patients with glaucoma who have a cup to disc ratio greater than 0.8.