A Phase 3 Study of UGN-102 for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

Inclusion Criteria:

1. Capable of giving signed informed consent, which includes compliance with therequirements and restrictions listed in the informed consent form (ICF) and in theprotocol.

2. Patient who has newly diagnosed or historic LG-NMIBC (Ta) histologically confirmedby cold cup biopsy at Screening or within 8 weeks of Screening.

3. Has intermediate risk disease, defined as having 1 or 2 of the following:

• Presence of multiple tumors;

• Solitary tumor > 3 cm;

• Recurrence (≥ 1 occurrence of LG-NMIBC within 1 year of the current diagnosis).

4. Negative voiding cytology for HG disease within 6 weeks of Screening.

5. Has adequate organ and bone marrow function as determined by the following routinelaboratory tests:

• Leukocytes ≥ 3,000 cells per μL;

• Absolute neutrophil count ≥ 1,500 cells per μL;

• Platelets ≥ 100,000 per μL;

• Hemoglobin ≥ 9.0 g/dL;

• Total bilirubin ≤ 1.5 x upper limit of normal (ULN);

• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 ×ULN;

• Alkaline phosphatase (ALP) ≤ 2.5 × ULN;

• Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min.

6. Has no evidence of active urinary tract infection (UTI).

7. Contraceptive use by men and women should be consistent with local regulationsregarding the methods of contraception for clinical study participants. Women ofchildbearing potential (defined as premenopausal women who have not beensterilized), including female patients and female partners of male patients, must bewilling to use 2 acceptable forms of effective contraception from enrollment through 6 months post-treatment.

Exclusion Criteria:

1. History of carcinoma in situ (CIS) on preliminary cystoscopy within 5 years ofenrollment.

2. Received Bacillus Calmette-Guérin (BCG) treatment for urothelial carcinoma (UC)within previous 1 year.

3. History of HG papillary UC in the past 2 years.

4. Known allergy or sensitivity to mitomycin that in the investigator's opinion cannotbe readily managed.

5. Clinically significant urethral stricture that would preclude passage of a urethralcatheter.

6. History of pelvic radiotherapy.

7. History of:

• Neurogenic bladder;

• Active urinary retention;

• Any other condition that would prohibit normal voiding.

8. Past or current muscle invasive (ie, T2, T3, T4) or metastatic UC or concurrentupper tract UC.

9. Current tumor stage of T1.

10. Has an underlying substance abuse or psychiatric disorder such that, in the opinionof the investigator, the patient would be unable to comply with the protocol.

11. History of prior treatment with an intravesical chemotherapeutic agent except for asingle dose of chemotherapy immediately after any previous TURBT.

12. Has previously participated in a study in which they received UGN-102.

13. Has participated in a study with an investigational agent or device within 30 daysof randomization.