Brepocitinib meets primary endpoint in both Phase 3 CLARITY trials in non-infectious uveitis

What's the deal? Roivant Sciences and its majority-owned subsidiary Priovant Therapeutics reported positive results from the Phase 3 CLARITY programme evaluating brepocitinib, an investigational once-daily oral treatment, in non-infectious uveitis (NIU) — a group of inflammatory eye diseases that can cause vision loss. The drug met the primary endpoint in both the CLARITY-1 and CLARITY-2 studies, which together enrolled 371 patients who received brepocitinib or placebo for 48 weeks. The primary endpoint was time to treatment failure measured from week 6 through week 48, and benefits were consistent across key patient subgroups, including different types and causes of uveitis. Safety findings were in line with earlier trials, with no new safety signals.

Why it matters: If approved, brepocitinib would be the first oral therapy for non-infectious uveitis — most patients currently rely on steroid eye drops, injections or systemic immunosuppressants. Priovant plans to file a supplemental New Drug Application with the US FDA in the first half of 2027. The news lifted Roivant's shares nearly 9% in premarket trading on 21 October 2026. Brepocitinib's commercial brand name is LISRAYA, which won US approval in 2026 as the first oral treatment for the autoimmune muscle disease dermatomyositis.

Read more: RTTNews, 21 October 2026 · GlobeNewswire, 21 October 2026