Non-corticosteroid approved for non-infectious uveitis

The FDA has approved the first non-corticosteroid therapy for non-infectious intermediate, posterior and panuveitis in adults.

The FDA’s decision marks the 10th approved indication for AbbVie’s adalimumab (Humira) in the United States. Adalimumab is already approved in the European Union.

"These approvals provide a valuable option for patients experiencing flare and vision impairment associated with this group of inflammatory diseases of the eye," said Glenn J. Jaffe, MD, of Duke University. "Data from the robust Visual clinical trial program demonstrate the value of Humira as a treatment option for patients with these serious diseases."

This approval was based on results from 2 pivotal phase 3 studies, Visual-I and Visual-II, which demonstrated that adults with active and controlled non-infectious intermediate, posterior and panuveitis had a significantly lower risk for treatment failure compared to placebo. No new safety risks were identified for adult patients who were treated with adalimumab biweekly.