On July 28, 2025 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative treatments for urothelial and specialty cancers, reported the publication in Reviews in Urology of results from a Phase 3b study evaluating the feasibility of administering ZUSDURI (mitomycin) for intravesical solution (formerly known as UGN-102) in the home setting (Press release, UroGen Pharma, JUL 28, 2025, View Source [SID1234654575]). 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," demonstrated that trained home health professionals (HHPs) can safely and effectively administer ZUSDURI outside of a traditional clinical setting.
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"The ability to deliver this treatment safely and effectively at home has the potential to ease the burden on patients and reduce reliance on hospital or clinic resources," said David Morris, MD, lead investigator and practicing urologist at Urology Associates, PC, Nashville, TN. "As physicians, we’re always looking for ways to provide effective care with greater comfort and convenience. These findings represent an important step in that direction."
The study assessed the feasibility, safety, and early efficacy of at-home instillations of ZUSDURI in patients with recurrent LG-IR-NMIBC. Six of eight patients (75%) completed all six scheduled treatments, with five of those six patients indicating they would recommend the home-based approach to others. A 75% complete response (CR) rate was observed at three months (95% CI: 34.9, 96.8), and no new safety concerns were identified. Feasibility questionnaires were completed by patients, and HHPs throughout the study. After each home instillation, patients rated their experience based on comfort, safety, communication, preference compared to office instillation, and overall satisfaction. At study end, they were also asked whether they would recommend home instillation of ZUSDURI to other patients and as an alternative to undergoing TURBT. Investigators assessed the clinical comparability of home versus in-office administration. HHPs provided feedback after each visit and at the study’s conclusion, reporting on their comfort with the procedure, perceived difficulty, and adequacy of training and support.
"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," said Mark Schoenberg, MD, Chief Medical Officer, UroGen. "The ability to potentially administer ZUSDURI safely in the home represents a meaningful advancement for patients and caregivers alike, especially those who may face challenges traveling to frequent clinic visits."
In this study, ZUSDURI was administered via urinary catheter once weekly for six weeks, with the first dose administered in the clinic, followed by five at-home instillations by HHPs. Investigators found no meaningful differences between home and office instillation for most patients. The safety profile was consistent with previous studies, with most adverse events being mild-to-moderate urinary symptoms.
Study limitations include, among others, the small sample size of eight patients, and the open-label and single-arm design.
About ZUSDURI
ZUSDURI (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, approved for the treatment of adults with recurrent LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel technology, a sustained release, hydrogel-based formulation, ZUSDURI is delivered directly into the bladder in an out-patient procedure by a trained healthcare professional using a urinary catheter to enable the treatment of tumors by non-surgical means. Patients can visit ZUSDURI.com for more information.
About Non-Muscle Invasive Bladder Cancer (NMIBC)
LG-IR-NMIBC affects around 82,000 people in the U.S. every year and of those, an estimated 59,000 are recurrent. Bladder cancer primarily affects older populations with increased risk of comorbidities, with the median age of diagnosis being 73 years. Guideline recommendations for the management of NMIBC include TURBT as the standard of care. Up to 70 percent of NMIBC patients experience at least one recurrence, and LG-IR-NMIBC patients are even more likely to recur and face repeated TURBT procedures. Learn more about non-muscle invasive bladder cancer at www.BladderCancerAnswers.com.