Priovant Will Seek Expanded Approval of Lisraya After Positive Results in Inflammatory Eye Disease

Rare Daily Staff

Roivant and its subsidiary Priovant Therapeutics said their drug Lisraya significantly delayed treatment failure in two phase 3 trials involving patients with non-infectious uveitis, an inflammatory eye disease that can cause permanent vision loss.

The once-daily pill met the main goal and all key secondary goals in both studies. Lisraya, also known as brepocitinib, is already approved for adults with dermatomyositis, an autoimmune disease. Priovant plans to submit a supplemental application to the U.S. Food and Drug Administration to expand the drug’s approved uses to include non-infectious uveitis.

Across the two studies, 62 percent of patients receiving Lisraya had no active inflammation in either eye and were off steroids at week 48, compared with 20 percent receiving placebo. The findings suggest the drug could help patients maintain disease control without continued steroid treatment.

Non-infectious uveitis involves inflammation inside the eye that is not caused by an infection. It can cause pain, floaters, and problems with vision that interfere with reading, driving, and other everyday activities.

Lisraya blocks TYK2 and JAK1, enzymes involved in immune signaling. Its existing prescribing information includes a boxed warning.

The two trials, CLARITY-1 and CLARITY-2, enrolled 371 patients. Participants were randomly assigned to receive either 45 milligrams of Lisraya or placebo once daily for 48 weeks. Neither patients nor investigators knew which treatment participants received.

All participants also received an initial course of oral corticosteroids, starting at 60 milligrams daily for two weeks. The dose was then reduced over six weeks until steroids were stopped, leaving 40 weeks of the study without scheduled steroid treatment.

The main measure was how long patients went before treatment failure, assessed from week six through week 48. The median time to failure exceeded 48 weeks in the Lisraya groups in both studies, compared with about 12 weeks in the placebo groups.

By week 48, the estimated proportion of patients who had experienced treatment failure was about 35 percent with Lisraya versus 79 percent with placebo in CLARITY-1. In CLARITY-2, the corresponding figures were about 32 percent and 78 percent. Both trials’ primary results were statistically significant.

Lisraya also outperformed placebo on measures of blood-vessel leakage in the eye, retinal swelling, and patients’ reported ability to carry out vision-related activities.

Among eyes with macular edema at the start of the studies, 42 percent in the Lisraya groups had resolution of the swelling at week 48, compared with 4.8 percent in the placebo groups. Macular edema is swelling in the part of the retina responsible for central vision.

The companies said most adverse events were mild or moderate, and 3 percent of participants discontinued treatment because of an adverse event. They reported no new safety signals but did not provide a detailed breakdown of adverse events in the announcement.