For the first time in nearly a decade, a new systemic therapy for uveitis may be on the horizon. Lisraya (brepocitinib), an oral TYK2/JAK inhibitor, met its primary endpoints in two phase 3 CLARITY trials, dramatically cutting treatment failure rates compared to placebo. A supplemental FDA application is planned for the first half of 2027.
It's been almost 10 years since the FDA last approved a systemic therapy for uveitis — but that drought may soon be over. Lisraya (brepocitinib 45 mg), an oral tyrosine kinase 2/Janus kinase (TYK2/JAK) inhibitor developed by Priovant and Roivant Sciences, hit its primary endpoint in both the CLARITY-1 and CLARITY-2 phase 3 trials for noninfectious uveitis. The drug, already approved for dermatomyositis, is now eyeing a new FDA indication, with a supplemental new drug application planned for early 2027.
The trials enrolled patients with intermediate, posterior, and panuveitis across a range of subtypes, including birdshot chorioretinopathy and sarcoidosis. Patients received once-daily brepocitinib or placebo for 48 weeks alongside a tapering corticosteroid regimen.
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Why it matters: Uveitis can cause serious, vision-threatening complications, and current treatment options are limited. An effective, non-invasive oral therapy could transform how clinicians manage this complex inflammatory eye disease — offering patients a far less burdensome alternative to injections.
