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# Roivant/Priovant Report Positive Data on Non-Infectious Uveitis Drug
- URL: https://www.fdaweb.com/roivant-priovant-report-positive-data-on-non-infectious-uveitis-drug-2/
- Published: 2026-10-21T18:07:05.000Z
- Updated: 2026-10-21T18:07:05.000Z
- Author: David McFarland
- Tags: Drugs

Roivant and Priovant Therapeutics have announced positive results from the Phase 3 CLARITY program evaluating brepocitinib in non-infectious uveitis (NIU). The drug met the primary endpoint for both the CLARITY-1 and CLARITY-2 studies, according to the company. It also achieved “statistically significant and clinically meaningful benefit on all key secondary endpoints, including measurements of sustained steroid-free quiescence at Week 48, chorioretinal vascular leakage, resolution of macular edema and patient-reported visual functioning,” it says.

FDA approved brepocitinib (Lisraya) in August as a once-daily oral tablet approved for treating dermatomyositis in adults. Priovant intends to file a supplemental NDA for brepocitinib for treating NIU in the first half of 2027.

NIU is described as a debilitating ocular inflammation and one of the leading causes of blindness among the working-age population. “Undertreated NIU can result in permanent vision loss,” the companies say. “NIU is frequently associated with ocular pain, floaters and visual impairment across multiple domains (acuity, peripheral vision, color recognition, ability to focus on moving objects, night vision, etc.) that can interfere with everyday activities including reading the newspaper, driving, socializing, working and independent self-care.”