AbbVie's Humira Gains Sixth Indication in China, Entering Ophthalmology with Approval for Non-Infectious Uveitis

AbbVie today announced that the China National Medical Products Administration approved HUMIRA® (adalimumab injection) on March 24, 2020, for the treatment of adult patients with non-infectious intermediate uveitis, posterior uveitis, and panuveitis who have had an inadequate response to corticosteroids, require a steroid-sparing approach, or are unsuitable for corticosteroid therapy.

This marks the sixth indication approved for Humira® in China, signifying its entry into a new therapeutic area—ophthalmology—following its previous approvals in rheumatology and immunology, dermatology, gastroenterology, and pediatrics. Humira® is currently the first and only biologic agent approved in China for the treatment of adult patients with non-infectious intermediate, posterior, and panuveitis.

This approval is based on the results of two global pivotal Phase 3 clinical studies—VISUAL-I and VISUAL-II—as well as an open-label extension study—VISUAL-III. The study results demonstrated that, compared with placebo, patients with active or inactive non-infectious intermediate, posterior, or panuveitis who received treatment with HUMIRA® had a significantly reduced risk of treatment failure (defined as worsening in any one of the following four criteria: anterior chamber cell grade, vitreous haze grade, emergence of new intraocular inflammatory lesions, and visual acuity). No new safety risks were identified in adult patients with non-infectious uveitis treated with HUMIRA® every other week in these studies.[1], [2], [3]

Non-infectious intermediate, posterior, and panuveitis are a group of immune-mediated intraocular inflammatory diseases that can lead to complications such as iris adhesions, glaucoma, cataracts, macular edema, and retinopathy in patients. In severe cases, it may result in blindness and is often associated with systemic immune-mediated diseases such as psoriasis and ankylosing spondylitis.