Roivant's Brepocitinib Meets Primary Endpoint in Both Phase 3 Uveitis Trials, Cutting Treatment Failure by More Than Half

ROIV and its subsidiary Priovant Therapeutics said on Oct. 21 that brepocitinib met the primary endpoint in both the CLARITY-1 and CLARITY-2 Phase 3 trials in non-infectious uveitis, an inflammatory eye disease. The program enrolled 371 patients across two identical studies, randomized to brepocitinib 45 mg once daily or placebo for 48 weeks, with steroids tapered to zero. The primary endpoint was time to treatment failure, and the median time exceeded 48 weeks on brepocitinib against about 12 weeks on placebo, with hazard ratios of 0.27 and 0.22 and p<0.0001 in both trials.

The absolute differences were large. Cumulative treatment failure at week 48 was 35.4% versus 78.7% on placebo in CLARITY-1 and 32.4% versus 77.8% in CLARITY-2. On key secondary endpoints, pooled steroid-free quiescence in both eyes reached 62% versus 20%, and pooled resolution of macular edema was 42% versus 4.8%. The drug was generally well tolerated, with 3% of patients discontinuing for adverse events and no new safety signals reported.

Brepocitinib is not a new drug to regulators: the FDA approved it as LISRAYA for adults with dermatomyositis in August 2026, and Priovant already sells it in the United States. The uveitis data would therefore support a supplemental application, which Priovant plans to file in the first half of 2027. Roivant owned 72% of Priovant's shares (66% fully diluted) as of March 31, 2026, according to its annual report, with Pfizer, which licensed the drug, holding a minority stake. Trials in cutaneous sarcoidosis and lichen planopilaris are ongoing.

Roivant shares rose nearly 9% in premarket trading from a $34.92 prior close and were up 6.3% during the session. The next markers are Roivant's fiscal second-quarter report on Nov. 9 and an investor day on Dec. 9, where investors will look for the commercial case for a second LISRAYA indication.