Talk Bio

Roivant Sciences and its subsidiary Priovant reported positive results from two Phase 3 trials, CLARITY-1 and CLARITY-2, testing Lisraya (brepocitinib) for non-infectious uveitis, an inflammatory eye disease that can threaten vision. Across the trials’ 371 participants, Lisraya significantly delayed treatment failure: median time exceeded 48 weeks, compared with about 12 weeks on placebo. The drug also met the trials’ key secondary endpoints. In pooled results, 62% of patients taking Lisraya had steroid-free disease control at week 48, versus 20% on placebo. Among eyes with macular edema at the start, 42% had resolution by week 48, versus 4.8% with placebo. The findings could put Lisraya in contention with Humira, currently the only FDA-approved systemic biologic specifically for non-infectious uveitis. However, the trials did not directly compare the drugs, so claims of superiority are based on cross-trial comparisons. Priovant plans to seek an FDA label expansion for uveiti...