Roivant Lisraya succeeds in two uveitis trials
Life Sciences
Wednesday, October 21, 2026
- Updated Oct 21, 2026 11:25
Roivant and Priovant said brepocitinib, sold as Lisraya, met its primary endpoint in both CLARITY Phase 3 trials in noninfectious uveitis, with steroid free remission at week 24 in 44.4 percent and 51.5 percent of patients, and an approval filing planned for the first half of 2027.
Why it matters: An approval would extend Lisraya beyond dermatomyositis, cleared in August, into a US market Roivant puts at 70,000 to 190,000 patients, and Priovant says a positive study in a second indication de-risks its wider brepocitinib programme.
Data as of Roivant press release of October 21, 2026, as reported in full by Endpoints News, with the market size and dermatomyositis approval context corroborated by STAT, October 21, 2026, read in its ungated text. Company announced results, single primary publisher, so this item is graded C. Developing item.
Roivant and its subsidiary Priovant said on Wednesday that brepocitinib, sold as Lisraya, succeeded in both CLARITY Phase 3 trials in noninfectious uveitis, an inflammatory eye disease, with steroid free clinical remission at week 24 in 44.4 percent of patients in CLARITY 1 (p less than 0.0001 against placebo) and 51.5 percent in CLARITY 2 (p equal to 0.0005). Both trials also met their key secondary endpoints, and no new safety signals were observed, the companies said.
Priovant plans to file for approval in the first half of 2027, which would expand the drug beyond dermatomyositis, the rare skin disease it was cleared for in August. Roivant estimates 70,000 to 190,000 patients in the United States have noninfectious uveitis, with more than 40,000 already receiving Humira or a similar therapy, STAT reported.
Sources
- Roivant's autoimmune drug succeeds in two pivotal trials, setting up 2027 filing - Endpoints News - 2026-10-21
- Immune drug from Roivant succeeds in new eye disease - STAT - 2026-10-21