Roivant and its subsidiary, Priovant Therapeutics, have scored another late-stage win for their marketed ophthalmology therapy, Lisraya (brepocitinib), in non-infectious uveitis (NIU) – potentially teeing the drug up for a label expansion into a new patient population.
This comes after the drug demonstrated significant efficacy during the Phase III CLARITY programme (NCT06431373), which enrolled 371 patients with NIU across two identical studies. Researchers randomised individuals to receive a once-daily dose of either Lisraya or placebo for 48 weeks, though all patients received an 8-week steroid regimen. The Janus kinase (JAK) and tyrosine kinase 2 (TYK2) inhibitor met both the primary endpoint and all key secondary endpoints in both CLARITY-1 and CLARITY-2.
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During both studies, Lisraya significantly extended the time to treatment failure over placebo, with individuals given the drug experiencing a median time of more than 48 weeks compared with 12 weeks in the placebo arm. Meanwhile, pooled results from the CLARITY trials revealed that 62% of Lisraya-treated patients remained stable or inactive in their disease without steroid usage at week 48 – 42 percentage points higher than the rate seen in the placebo arm – highlighting the drug’s potential to reduce reliance on chronic steroid usage.
On top of this, Lisraya also offered benefits to patients with macular oedema, as 42% of eyes treated with the drug in the CLARITY programme achieved resolution of this affliction at week 48 versus 4.8% in the placebo arm.
Patients with NIU generally tolerated Lisraya well; researchers observed no new safety signals linked to the drug, and only 3% of patients discontinued treatment with the drug due to an adverse event (AE).
NIU is an immune-mediated inflammatory eye disease that impact the middle of the eye, which can lead to permanent vision loss if not effectively treated. Currently, AbbVie’s once best-selling anti-TNF-α therapy, Humira (adalimumab) and its biosimilars are the standard of care treatment for patients who are either not responding or cannot tolerate treatment with corticosteroids and immunosuppressants.
Roivant eyes a place for Lisraya on the stagnant NIU market
With positive results in the bag, Roivant will use data from the CLARITY programme to form the foundations of a supplemental new drug application (sNDA) for Lisraya in NIU, which the company hopes to submit to regulators in the first half of 2027. Currently, US regulators have approved the drug for the treatment of adults with the muscle and skin-impacting autoimmune condition dermatomyositis.
If Lisraya were to obtain the regulatory greenlight in NIU, it would join a market currently dominated by Humira (adalimumab) and its biosimilars. However, Priovant’s CEO, Ben Zimmer, believes that the “breadth and magnitude of benefit” observed in the CLARITY studies could position Lisraya as a new standard of care in NIU.
Quan Dong Nguyen, investigator on the CLARITY programme and professor of ophthalmology at the Byers Eye Institute echoes Zimmer’s sentiments, noting that Lisraya could represent “a potential turning point for the field of uveitis,” as there have been no new non-steroid options approved in nearly a decade.
Analysts are also hopeful for Lisraya’s potential future on the NIU market, with the team at Jefferies noting that the drug could reach a sales peak of “$2-3bn post-Humira”. Meanwhile, Leerink analysts say that the data on Lisraya “looks superior to Humira on a cross-trial basis with a much more aggressive steroid tapering schedule.”
According to a recent report from GlobalData, parent company of Clinical Trials Arena, analysts expect the wider uveitis market to balloon at a compound annual growth rate (CAGR) of 10.9% to reach a value of $1.5bn by 2033.
