UroGen Pharma Ltd (Nasdaq: URGN) has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for a potential new treatment for patients with low-grade non-muscle invasive bladder cancer (LG NMIBC), the biopharmaceutical company reported on Wednesday.

The application relates to UGN-102 (VesiGel, mitomycin gel for intravesical instillation), which has the potential to become the first front-line non-surgical therapy for patients with LG NMIBC.

The company's proposed Phase 2b single-arm, open-label, multi-centre trial is designed to assess the efficacy and safety of UGN-102 as a first-line chemoablation agent in the treatment of patients with LG NMIBC at risk for recurrence. Transurethral resection of bladder tumor (TURBT) followed by adjuvant chemotherapy or immunotherapy is the current standard of care.

NMIBC accounts for approximately 80% of all new cases of bladder cancer diagnosed in the United States each year, and the majority of patients face life-long, repetitive surgical treatment for cancer recurrence, UroGen said.

The company expects to start the Phase 2b clinical trial in the third quarter of 2018.