UroGen Pharma Publishes Phase 3b Study Data on Home Instillation of ZUSDURI for NMIBC Patients

UroGen Pharma has published data from a Phase 3b study on the feasibility of at-home instillations of ZUSDURI for recurrent non-muscle invasive bladder cancer. The study found no significant differences between home and office instillation, with a consistent safety profile and most adverse events being mild-to-moderate urinary symptoms. The results suggest the possibility of home administration for this treatment.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company focused on innovative treatments for urothelial and specialty cancers, has published data from a Phase 3b study evaluating the feasibility of at-home instillations of ZUSDURI for recurrent non-muscle invasive bladder cancer (NMIBC). The study, titled "Home Instillation of UGN-102 for Primary Chemoablation of Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer: A Single-Arm, Open-Label, Phase 3b Trial," was published in Reviews in Urology [1].

The study involved eight patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). ZUSDURI, an intravesical solution of mitomycin, was administered via urinary catheter once weekly for six weeks, with the first dose administered in the clinic and the subsequent five doses administered at home by trained home health professionals (HHPs). The study aimed to assess the feasibility, safety, and early efficacy of at-home instillations.

Key findings from the study include:
- Feasibility: Six out of eight patients completed all six scheduled treatments, with five of those patients indicating they would recommend the home-based approach to others.
- Safety: No new safety concerns were identified, and the safety profile was consistent with previous studies. Most adverse events were mild-to-moderate urinary symptoms.
- Efficacy: A 75% complete response (CR) rate was observed at three months (95% CI: 34.9, 96.8).

The study also included patient and HHP feedback questionnaires, which reported high levels of satisfaction with the home instillation process. Investigators found no meaningful differences between home and office instillation for most patients.

The results suggest that home administration of ZUSDURI is feasible and safe, potentially easing the burden on patients and reducing reliance on hospital or clinic resources. However, the study had limitations, including a small sample size and an open-label, single-arm design.

UroGen Pharma's Chief Medical Officer, Mark Schoenberg, MD, noted, "This patient-centered approach to care reflects our commitment to redefining how urologic cancers are treated, offering patients access to effective and convenient treatment options."

The study's findings are significant for patients with LG-IR-NMIBC, who often face challenges with frequent clinic visits and repeated TURBT procedures. The ability to administer ZUSDURI safely at home represents a meaningful advancement for these patients and caregivers.

References:
[1] https://www.globenewswire.com/news-release/2025/07/28/3122406/0/en/UroGen-Announces-Publication-of-Phase-3b-Study-Results-Demonstrating-the-Feasibility-of-Home-Instillation-of-ZUSDURI-for-Recurrent-Low-Grade-Intermediate-Risk-Non-Muscle-Invasive-B.html
[2] https://www.nasdaq.com/articles/urogen-pharma-publishes-phase-3b-study-data-showing-feasibility-home-instillation-zusduri
[3] https://www.marketscreener.com/news/urogen-announces-publication-of-phase-3b-study-results-demonstrating-the-feasibility-of-home-instill-ce7c5fd8dd8ff325