A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer

Eligible patients were treated with UGN-103 once weekly for 6 weeks (a total of 6 doses). Efficacy was assessed by the complete response rate (CRR) at the 3-month Visit (approximately 3 months after the first instillation). Response was determined based on visual observation (white light cystoscopy), histopathology of any remaining or new lesions by central pathology lab (if applicable), and interpretation of urine cytology by central pathology lab. Patients who had a complete response (CR) at the 3-month Visit, defined as having no detectable disease (NDD) in the bladder, entered the Follow-up Period of the study. During the Follow-up Period, patients return to the clinic every 3 months for evaluation of response. Patients remain on study until disease recurrence, disease progression, death, or the last patient completes 12 months of follow-up (ie,12 months after the 3-month Visit), whichever occurs first. Patients who had a non-complete response (NCR) at the 3-month Visit underwent investigator-designated standard of care (SOC) and had a separate End of Study (EOS) Visit performed. Study conduct is ongoing and data are summarized through a cutoff date of 18 Mar 2026. As of the data cutoff date, ongoing patients were followed through at least Study Month 9, with the earliest enrolled patients followed through Study Month 15.