Brepocitinib meets primary endpoint in two phase 3 uveitis trials

Priovant, a Roivant Sciences subsidiary, said its drug brepocitinib met the primary endpoint of time to treatment failure in two Phase 3 trials of non-infectious uveitis with identical designs, Yahoo Finance reported on Friday. The trials, called CLARITY-1 and CLARITY-2, enrolled 371 patients who received once-daily treatment for 48 weeks.

In both studies, the median time to treatment failure exceeded 48 weeks for patients on brepocitinib, while the placebo group had a median of around 12 weeks. Pooled data from the two trials showed that 62% of patients receiving the drug achieved steroid-free quiescence at week 48, meaning no active inflammation and no steroid use, compared with 20% on placebo. Among eyes with macular edema at the start, 42% had resolution with brepocitinib versus 4.8% with placebo.

Priovant used a more aggressive steroid taper than earlier non-infectious uveitis trials, according to the company. Only 3% of patients discontinued treatment because of a side effect, and no new safety signals were reported.

Roivant shares climbed 8% on Friday after the announcement. Quan Dong Nguyen, MD, president of the International Ocular Inflammation Society and a Stanford ophthalmology professor, said the findings were “phenomenal results.”

Brepocitinib is already marketed as LISRAYA for adults with dermatomyositis. Non-infectious uveitis is a leading cause of blindness among working-age people, according to Yahoo Finance. Priovant estimates that 70,000 to 190,000 US adults have the condition and plans to submit an FDA filing in the first half of 2027. According to Yahoo Finance, analysts see Roivant revenue rising from $8.26 million for the fiscal year that ended March 2026 to $1.53 billion for the year ending March 2029, based on estimates from seven analysts. Roivant is scheduled to report financial results on Nov. 9 and hold an investor day on Dec. 9, when the company may discuss the size of the uveitis opportunity.