Following Lisraya’s first regulatory approval, Roivant and its subsidiary Priovant are seeking to expand the drug’s reach into additional immune-mediated conditions. The companies have reported positive results from two Phase 3 trials of brepocitinib, a once-daily inhibitor of TYK2 and JAK1, in noninfectious uveitis (NIU), an inflammatory eye disease that ranks among the major causes of blindness in working-age adults.
After the successful studies, Roivant announced Wednesday that Priovant intends to submit the findings to the U.S. Food and Drug Administration (FDA) during the first half of 2027. The company believes the extent and consistency of the observed benefits could position brepocitinib as a highly effective systemic, steroid-free treatment option for NIU.
At present, AbbVie’s Humira is the only systemic biologic specifically approved by the FDA for NIU, apart from corticosteroid treatments and biologics prescribed off-label. An approval would give brepocitinib a second indication following its authorization in late August as Lisraya for dermatomyositis (DM), an autoimmune disorder associated with progressive muscle weakness and skin lesions that can cause itching and discomfort.
The Clarity-1 and Clarity-2 trials followed identical designs and enrolled a combined 371 participants. Their primary goal measured the time to treatment failure between weeks 6 and 48.
Across both studies, brepocitinib consistently reduced treatment failure compared with placebo, with benefits observed across multiple patient subgroups. In Clarity-1, the cumulative treatment failure rate at week 48 was over 35% among patients receiving the drug, compared with 78.7% in the placebo group. In Clarity-2, the corresponding rates for the 45 mg dose were 32.4% and just under 78%, respectively.
Combined results also showed that over 60% of patients treated with brepocitinib achieved disease control without steroids by the 48th week, compared with 20% of those receiving placebo.
The pooled analysis further highlighted an improvement in macular edema, a condition involving fluid accumulation in the central part of the retina. Among eyes affected by macular edema at the start of the studies, 42% in the brepocitinib group experienced resolution by the 48th week, compared with under 5% in the placebo group.
Jefferies analysts emphasized the importance of the macular edema findings, noting that the condition is a major contributor to vision loss in people with NIU. They also highlighted the consistent treatment response, the ability to stabilize the disease and the proportion of patients who achieved these benefits while discontinuing steroid treatment.
When inadequately controlled, NIU can cause irreversible vision loss. Patients may also experience eye pain, floaters and difficulties with several aspects of vision, including peripheral awareness, color perception, visual sharpness and tracking moving objects. Roivant estimates that the disease affects between 70,000 and 190,000 adults in the U.S.
Analysts have already forecast substantial commercial potential for Lisraya. In an investor presentation released Wednesday, Roivant indicated that the NIU market could be comparable in size to the opportunity in dermatomyositis, the drug’s first approved indication.
Jefferies analysts estimated that each indication under development for Lisraya could generate peak annual sales of at least $1 billion to $3 billion.
Roivant Reports Positive Results in Eye Disease Trials
Roivant Sciences has reported encouraging Phase 3 results for Lisraya, its oral immunomodulatory medicine, in patients with non-infectious uveitis (NIU), an inflammatory eye condition that can threaten vision. Announced on October 21, 2026, the results came from the CLARITY-1 and CLARITY-2 trials, conducted by Roivant subsidiary Priovant Therapeutics. The studies evaluated brepocitinib, the active ingredient in Lisraya, against a placebo in patients with this potentially sight-threatening condition. Both trials met their primary endpoints and demonstrated significant improvements across key secondary measures. These findings could support Roivant’s plans to expand the medicine into another major autoimmune disease market.
