Roivant reports positive Phase 3 results for brepocitinib in non-infectious uveitis

Roivant Sciences Ltd. (ROIV) said on Wednesday that its subsidiary Priovant Therapeutics, Inc. reported positive Phase 3 results for brepocitinib in non-infectious uveitis, or NIU, a condition that can cause permanent vision loss if undertreated.

The CLARITY program enrolled 371 patients across two identical studies, CLARITY-1 and CLARITY-2. Patients were randomized 1:1 to once-daily brepocitinib 45 mg or placebo for a 48-week double-masked treatment period.

All patients first received an 8-week oral corticosteroid regimen of 60 mg a day for 2 weeks, followed by a mandatory 6-week taper to zero.

Both trials met the primary endpoint, time to treatment failure, assessed from Week 6 through Week 48. Median time to treatment failure was greater than 48 weeks for patients on brepocitinib in both studies, compared with about 12 weeks on placebo in each study, with p<0.0001 in both.

Pooled across the two studies, 62% of patients on brepocitinib achieved steroid-free quiescence at Week 48, compared with 20% on placebo. Among patients with macular edema at entry, 42% of eyes on brepocitinib achieved resolution at Week 48, compared with 4.8% on placebo.

In CLARITY-1, the hazard ratio for treatment failure versus placebo was 0.27 (95% CI 0.17–0.43). In CLARITY-2 it was 0.22 (95% CI 0.14–0.34). Cumulative incidence of treatment failure at Week 48 was 35.4% on brepocitinib versus 78.7% on placebo in CLARITY-1, and 32.4% versus 77.8% in CLARITY-2.

Only 3% of participants discontinued treatment due to an adverse event, the company said, and the safety profile was consistent with the known profile of brepocitinib, with no new safety signals observed.

Priovant intends to file a supplemental New Drug Application for brepocitinib for NIU in the first half of calendar 2027. Its commercial product, LISRAYA, is the first and only targeted oral therapy approved for adults with dermatomyositis.

Priovant CEO Ben Zimmer said: "The breadth and magnitude of benefit seen in the CLARITY studies position brepocitinib to potentially set a new standard for the treatment of non-infectious uveitis."

Roivant will host an investor call and webcast at 8:00 a.m. ET on Wednesday, October 21, 2026. It will also host an investor day on Wednesday, Dec. 9, 2026.

The release does not give a date for a regulatory decision on NIU.