Shots:

• The P-III (ENVISION) study evaluates the efficacy & safety of UGN-102 (intravesical sol.) as primary chemoablative therapy in ~220 patients with NMIBC across 90 sites. The study is similar to P-IIb (OPTIMA II) study & patients will have the same clinical characteristics, treatment regimen, assessment & qualitative follow up with different EPs
• The 1EP is CRR @3mos. after 1st instillation & 2EPs will be durability in patients who achieve complete response at 3mos. assessment
• The company is planning to submit an NDA for UGN-102 in 2024. The company will continue to explore the benefits of chemoablation in other types of bladder cancer including high-grade disease & other specialty cancers

Ref: Businesswire | Image: Businesswire