Roivant Sciences and Priovant Therapeutics announced positive Phase 3 results for brepocitinib (Lisraya) in non-infectious uveitis, an inflammatory eye disease affecting up to 190,000 U.S. adults. Across the CLARITY-1 and CLARITY-2 studies of 371 patients, brepocitinib extended median time to treatment failure beyond 48 weeks and enabled 62% of patients to maintain steroid-free disease control. Priovant plans to submit a supplemental sNDA in early 2027.
Phase 3 trial efficacy results for brepocitinib
- ▪Brepocitinib treatment resolved macular edema in 42% of affected eyes at Week 48 in pooled Phase 3 CLARITY study data, compared with 4.8% on placebo.
- ▪Patients treated with brepocitinib in the Phase 3 CLARITY trials went 40 weeks without requiring immunosuppressive corticosteroids, setting a new benchmark for non-infectious uveitis therapies.
- ▪In the CLARITY-1 and CLARITY-2 trials enrolling 371 patients, median time to treatment failure for brepocitinib exceeded 48 weeks, compared to approximately 12 weeks for placebo.
- ▪Roivant Sciences and Priovant Therapeutics announced on October 21, 2026, that once-daily 45 mg brepocitinib met its primary endpoint in the Phase 3 CLARITY-1 and CLARITY-2 trials for non-infectious uveitis.
- ▪In pooled data from the CLARITY studies, 62% of non-infectious uveitis patients on brepocitinib achieved steroid-free quiescence at Week 48, compared with 20% on placebo.
Safety profile in Phase 3 trials
- ▪Only 3% of clinical trial participants discontinued brepocitinib treatment due to an adverse event across the Phase 3 CLARITY studies.
- ▪Brepocitinib demonstrated a safety profile in the CLARITY trials consistent with prior clinical studies, showing no new safety signals.
Comparison to existing treatment options
- ▪Leerink Partners analysts noted that 50% of non-infectious uveitis patients fail on Humira within six months, while brepocitinib demonstrated cross-trial efficacy superiority under a more aggressive steroid taper.
- ▪AbbVie's Humira is currently the only FDA-approved systemic biologic treatment specifically indicated for non-infectious uveitis.
Lisraya regulatory and development pipeline
- ▪Priovant Therapeutics and Roivant Sciences estimated in October 2026 that they will submit a supplemental New Drug Application to the FDA for brepocitinib in non-infectious uveitis in the first half of calendar year 2027.
- ▪Roivant is mapping out development paths for Lisraya in two additional potential indications, cutaneous sarcoidosis and lichen planopilaris, beyond dermatomyositis and non-infectious uveitis.
Lisraya dermatomyositis approval and label
- ▪The FDA label for Lisraya carries a boxed warning typical of JAK inhibitors while permitting treatment across all adults with dermatomyositis.
- ▪The FDA approved brepocitinib under the brand name Lisraya in late August 2026 for treating adults with the rare autoimmune skin disease dermatomyositis.
Non-infectious uveitis impact and symptoms
- ▪Undertreated non-infectious uveitis can cause permanent vision loss, eye pain, floaters, and visual impairment affecting peripheral vision, color recognition, and focus.
- ▪Non-infectious uveitis affects an estimated 70,000 to 190,000 adults in the United States and represents one of the leading causes of blindness among working-age individuals.
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