Roivant and Priovant said brepocitinib hit the primary endpoint in both Phase 3 trials in the CLARITY program for non-infectious uveitis, with the treatment failure rate at week 48 sharply below placebo in each study.
In CLARITY-1, the cumulative incidence of treatment failure at week 48 was 35.4% for brepocitinib versus 78.7% for placebo, a 43.3-point gap. In CLARITY-2, the rate was 32.4% versus 77.8%, a 45.4-point gap. The hazard ratio for treatment failure was 0.27 in CLARITY-1 and 0.22 in CLARITY-2, with p-values below 0.0001 in both trials.
Steroid-free quiescence at week 48 was also materially higher with brepocitinib. In CLARITY-1, 58.8% of patients achieved it versus 19.8% on placebo. In CLARITY-2, the figures were 64.4% versus 19.4%.
For macular edema, resolution at week 48 among eyes with edema at baseline reached 40.4% in CLARITY-1 versus 2.1% on placebo, and 42.6% in CLARITY-2 versus 7.0% on placebo.
On wide-field fluorescein angiography response, 39.4% of eligible eyes responded in CLARITY-1 versus 8.6% on placebo, while CLARITY-2 showed 54.9% versus 7.2%.
Patient-reported visual functioning improved as well. A 5-point or greater improvement in the NEI VFQ-25 overall composite score was seen in 36.4% of CLARITY-1 patients versus 13.7% on placebo, and in 40.4% versus 14.1% in CLARITY-2.
The company also highlighted median time to treatment failure of more than 48 weeks on brepocitinib in both studies, compared with about 12 weeks on placebo, including 40 weeks of steroid-free treatment.
Safety data showed 3% of participants discontinued treatment because of an adverse event, and the company said there were no new safety signals.
Priovant said it plans to file a supplemental new drug application in the first half of 2027. The market has reacted to these announcements by moving the company's shares 0.63% to a price of $34.92. For more information, read the company's full 8-K submission here.
