Roivant's Brepocitinib Wins Two Phase 3 Uveitis Trials

Roivant and its subsidiary Priovant Therapeutics said on October 21, 2026, that brepocitinib met its main goal in two phase 3 trials in non-infectious uveitis. BioPharma Dive described the condition as an eye disease that can lead to blindness. Priovant plans to ask the FDA to add uveitis to the drug's label.

What happened

The CLARITY program enrolled 371 patients across two trials of the same design, CLARITY-1 and CLARITY-2, according to the companies' release. Patients were randomized one to one to brepocitinib 45 mg once a day or placebo for 48 weeks.

Every patient started on 60 mg a day of oral steroids for two weeks. The dose was then tapered to zero over six weeks. The main goal was time to treatment failure, measured from Week 6 to Week 48.

• Risk of failure: the hazard ratio was 0.27 in CLARITY-1 and 0.22 in CLARITY-2, with p-values below 0.0001 in both, the release said.
• Time to failure: the median was more than 48 weeks on brepocitinib, compared with about 12 weeks on placebo, in each study.
• Failure by Week 48: 35.4% versus 78.7% in CLARITY-1, and 32.4% versus 77.8% in CLARITY-2.
• Steroid-free control: pooled across both trials, 62% of brepocitinib patients had inactive disease in both eyes at Week 48 without steroids, versus 20% on placebo.
• Macular edema: in pooled data, this swelling cleared in 42% of affected eyes on the drug, versus 4.8% on placebo.

The drug met every key secondary goal in both trials, the companies said. About 3% of patients stopped treatment because of a side effect. The release reported no new safety signals.

Why it matters

Brepocitinib is a first-in-class oral drug that blocks two enzymes, TYK2 and JAK1, Ophthalmology Times reported. The FDA has already approved it as Lisraya for adults with dermatomyositis. Its use in uveitis is not approved.

The companies estimate that non-infectious uveitis affects 70,000 to 190,000 adults in the United States. Stanford professor Quan Dong Nguyen, quoted in the release, called the results "a potential turning point for the field of uveitis."

BioPharma Dive reported that a Stifel analyst said the data could make brepocitinib a "best-in-disease" medicine. A Cantor Fitzgerald analyst said uveitis could be a $5 billion peak sales indication for the drug, the outlet reported. BioPharma Dive also noted that the drug may work better than AbbVie's Humira in this disease. Still, the two drugs were not tested against each other, so that comparison is hard to make.

The result also matters for Pfizer. Roivant joined with Pfizer in 2022 to form Priovant, and Pfizer received a 25% stake, BioPharma Dive said.

What it means for people in the industry

Priovant plans to file a supplemental new drug application for uveitis in the first half of 2027. The sources do not mention hiring, new sites or staffing plans. People in ophthalmology, immunology, medical affairs and regulatory roles should watch that filing and sales of Lisraya, which Priovant says is now commercially available for dermatomyositis. Roivant has set an investor day for December 9, 2026.

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Sources

• Roivant and Priovant Announce Positive Results in CLARITY-1 and CLARITY-2 Phase 3 Trials for Brepocitinib in Non-Infectious Uveitis (NIU), Roivant Sciences press release (GlobeNewswire)
• Roivant, continuing ascent, claims another victory for rare disease drug, BioPharma Dive
• Brepocitinib meets all Phase 3 end points in noninfectious uveitis, Ophthalmology Times