On October 2, 2025 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company focused on developing and commercializing innovative solutions for urothelial and specialty cancers, reported the publication of a comprehensive review of the clinical development program for ZUSDURI (mitomycin) for intravesical solution, formerly known as UGN-102, the first and only FDA-approved medicine for adults with recurrent, low-grade, intermediate-risk non–muscle-invasive bladder cancer (LG-IR-NMIBC) (Press release, UroGen Pharma, OCT 2, 2025, View Source [SID1234656404]). The article titled: "Review of UGN-102: A Reverse Thermal Gel Containing Mitomycin for the Treatment of Recurrent, Low-Grade, Intermediate-Risk Non-Muscle Invasive Bladder Cancer" is published in the peer-reviewed journal Reviews in Urology, the official journal of LUGPA.

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"ZUSDURI is an FDA-approved, non-surgical treatment that has consistently demonstrated robust, clinically significant, and durable complete responses in patients with recurrent LG-IR-NMIBC," said publication author and ENVISION principal investigator Sandip Prasad, M.D., M.Phil., Director of Genitourinary Surgical Oncology and Vice Chair of Urology at Morristown Medical Center/Atlantic Health System, NJ. "With an acceptable safety profile manageable in routine urologic practice, ZUSDURI is administered in an outpatient setting without the need for general anesthesia. This review article highlights the clinical evidence supporting ZUSDURI’s role as an innovative option for patients with recurrent LG-IR-NMIBC."

Key Highlights from the Review:

High Complete Response Rates: Across late-stage clinical trials (OPTIMA II, ATLAS, and ENVISION), UGN-102 demonstrated complete response (CR) rates between 64.8% and 79.6% at three months.
Durable Disease Response: In the ENVISION trial, 80.6% of patients remained disease-free at 18 months following CR. Among the 41 patients who achieved CR in the OPTIMA II study, the median duration of response (DOR) was 24.2 months; among the 17 patients in the long-term follow-up study, the median DOR was 42.1 months. The median follow-up for the 17 patients in the long-term follow-up study was 50.4 months.
Manageable Safety Profile: Adverse events were primarily localized to the lower urinary tract. The most common (≥10%) adverse reactions (ARs) with ZUSDURI, including laboratory abnormalities, that occurred in patients were dysuria, increased potassium, increased creatinine, decreased hemoglobin, increased eosinophils, increased aspartate aminotransferase, increased alanine aminotransferase, decreased lymphocytes, urinary tract infection, decreased neutrophils, and hematuria. ARs were mainly mild to moderate. Serious ARs occurred in 12% of patients, including urinary retention (0.8%) and urethral stenosis (0.4%).
No Adverse Impact from Patient-Reported Outcomes: Clinical trials show that ZUSDURI did not adversely affect functionality, symptom burden, and quality of life in patients with LG-IR-NMIBC.
"This comprehensive review clearly explains the body of evidence supporting ZUSDURI as an innovative treatment option for patients with recurrent LG-IR-NMIBC," said Mark Schoenberg, M.D., Chief Medical Officer, UroGen. "By offering a non-surgical and durable solution, ZUSDURI represents a major advance in the way we care for these patients."

The clinical development program for ZUSDURI includes three late-phase clinical trials that investigated the safety and efficacy of ZUSDURI in patients with LG-IR-NMIBC: OPTIMA II, ATLAS, and ENVISION.

The newly diagnosed and recurrent patients with LG-IR-NMIBC included in the ZUSDURI clinical development program tended to be elderly (median ages 67-70 years across the studies). They also had a relatively high disease burden, with 60.3-82.8% having multiple tumors, 18.6-49.3% having aggregate tumor size greater than 3 cm, and 24.6-51.7% having LG recurrence within the year prior to their current diagnosis.

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 by a trained healthcare professional using a urinary catheter in an outpatient setting, thereby enabling the treatment of tumors by non-surgical means.

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 transurethral resection of bladder tumor (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.

About ENVISION
The Phase 3 ENVISION trial is a single-arm, multinational, multicenter pivotal study evaluating the efficacy and safety of ZUSDURI (mitomycin) for intravesical solution as a chemoablative therapy in adult patients with recurrent LG-IR-NMIBC. The Phase 3 ENVISION trial completed target enrollment with 240 patients across 56 sites. Study participants received six once-weekly intravesical instillations of ZUSDURI. The primary endpoint evaluated the CR rate at three months after the first instillation, and the key secondary endpoint evaluates durability over time in patients who achieved a CR at the three-month assessment. Learn more about the Phase 3 ENVISION trial at www.clinicaltrials.gov (NCT05243550).

About the Phase 2b OPTIMA II Trial

OPTIMA II (OPTimized Instillation of Mitomycin for Bladder Cancer Treatment) was an open-label, single-arm, multi-center Phase 2b clinical trial of ZUSDURI evaluating the safety and efficacy in patients with LG-IR-NMIBC. The trial enrolled 63 patients across 20 sites in the US and Israel. Learn more about the OPTIMA II trial at www.clinicaltrials.gov (NCT03558503).

About ATLAS

ATLAS was a global, open-label, randomized controlled Phase 3 trial designed to assess the efficacy and safety of UGN-102, with or without TURBT, vs. TURBT alone in patients diagnosed with LG-IR-NMIBC. The trial enrolled 282 patients in clinical sites in the U.S., Europe and Israel. UroGen halted patient enrollment in the ATLAS study in November 2021 to shift to an alternative development strategy, primarily focusing on the pivotal ENVISION trial for ZUSDURI. Learn more about the ATLAS trial at www.clinicaltrials.gov (NCT04688931).