Positive Phase III results for Humira (adalimumab) in Uveitis- AbbVie

AbbVie has announced results from VISUAL-I, a Phase III study investigating the efficacy and safety of Humira (adalimumab) in adult patients with active non-infectious intermediate, posterior, or panuveitis who still experienced intraocular inflammation while on systemic corticosteroid therapy. Results showed Humira significantly lowered their risk of uncontrolled uveitis or vision loss.

The VISUAL-I study found that compared to placebo, patients on Humira were less likely to experience treatment failure (TF) (hazard ratio=0.5; 95 percent CI, 0.36–0.70; P<0.001). Median time to TF was prolonged by 87 percent, from 3 months for placebo to 5.6 months for Humira. TF is a multi-component outcome based on chorioretinal or vascular lesions, best corrected visual acuity (BCVA), anterior chamber (AC) cell grade, and vitreous haze (VH) grade. The rates of adverse events (AEs) in VISUAL-I were 1,047 events per 100 patient?years (PY) for Humira-treated patients vs. 965 events per 100PY for placebo patients.

AbbVie is also evaluating the safety and efficacy of Humira in patients with inactive, non-infectious intermediate, posterior, or panuveitis, in the ongoing Phase III VISUAL II clinical trial and those results are expected soon. The results were presented at the Association for Research in Vision and Ophthalmology Annual Meeting.