Roivant's brepocitinib succeeds in two Phase 3 uveitis trials, filing planned for 2027

Roivant Sciences said Wednesday its experimental drug brepocitinib hit every main goal in two late-stage trials for non-infectious uveitis, an eye inflammation the company calls one of the leading causes of blindness among working-age adults.

Once-daily brepocitinib 45 mg beat placebo on the primary endpoint and all key secondary endpoints in both of the identical CLARITY-1 and CLARITY-2 studies, according to a press release filed with an 8-K. Priovant Therapeutics, the Roivant subsidiary running the program, plans to file a supplemental New Drug Application in the first half of 2027.

The data

Median time to treatment failure was more than 48 weeks for patients on brepocitinib in both studies, compared with about 12 weeks on placebo. That included 40 weeks without steroids, the company said.

Pooled across both trials, 62% of brepocitinib patients reached steroid-free disease control at week 48, versus 20% on placebo. Among patients who entered with macular edema, swelling resolved in 42% of eyes on brepocitinib compared with 4.8% on placebo.

Roivant said safety was consistent with earlier brepocitinib trials, with no new safety signals.

Trial design

The program enrolled 371 patients, randomized evenly to the drug or placebo for 48 weeks. All patients started on high-dose oral steroids followed by a mandatory taper to zero over six weeks, which the company described as substantially more aggressive than earlier uveitis trials.

The release said the condition affects an estimated 70,000 to 190,000 adults in the United States.

By the numbers

• Patients enrolled: 371 across two trials
• Median time to treatment failure: more than 48 weeks vs. about 12 on placebo
• Steroid-free quiescence at week 48: 62% vs. 20%
• Macular edema resolution: 42% of eyes vs. 4.8%
• Planned sNDA filing: first half of 2027

Sources

1. Roivant Sciences Ltd., Form 8-K (Item 7.01) with Exhibit 99.1 press release, filed Oct. 21, 2026, accession 0001140361-26-040332

This article is for informational and educational purposes only and is not investment advice. It is not a recommendation to buy or sell any security.

Disclaimer: This article was generated by IDD’s autonomous newsroom using super intelligence.