Trial launches of Optilume drug-coated balloon for benign ureteric strictures

The first procedures have been completed in the ENDURE 1 study (NCT07020520), evaluating the safety and feasibility of the Optilume drug-coated balloon (DCB) for the treatment of patients with benign ureteric strictures, Laborie announced in a news release.¹

According to the company, “The Optilume DCB combines mechanical dilation with localized delivery of paclitaxel, an established antiproliferative drug, to help prevent scar tissue recurrence and is designed to help maintain long-term ureteral patency.” The device is currently approved for the treatment of patients with anterior urethral strictures and for patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia.

The first procedures in the study were completed by Jaime Landman, MD, at the University of California, Irvine Health.

"Patients with ureteric strictures have limited durable solutions and face significant challenges, including the risk of severe kidney damage," Landman stated in the news release.¹ "Optilume's novel combination of dilation and drug delivery has the potential to transform how we treat this notoriously difficult condition."

In total, the prospective ENDURE 1 trial plans to enroll up to 60 patients across multiple clinical trial sites in the US.² Patients enrolled in the study must have a single lesion ureteric or uretero-enteric structure up to 4 cm in length as well as 2 functioning kidneys.

All patients will receive treatment with the Optilume device, and patients enrolled in the pharmacokinetic substudy (n = 15) will also have serum and urine samples collected for analysis of paclitaxel levels. Participants may be followed for over 5 years.

The primary end point for the study is the rate of successful treatment, which may include technical success, freedom from retreatment through 6 months post-stent removal, stability or improvement in split function for impacted kidney per renogram at 6 months, or T1/2 stability or improvement from baseline to 6 months for impacted kidney. The study will also evaluate patient-reported outcomes.

Primary completion of the trial is expected in February 2027, with final completion planned for July 2031.

"We are proud to achieve this important milestone for Optilume in the ureters," said Chris Smith, CEO of Laborie, in the news release.¹ "This innovation builds on the proven clinical success of Optilume in anterior urethral strictures and represents a significant step toward expanding treatment options for patients with limited choices."

REFERENCES

1. Laborie announces first procedures in ENDURE 1 study with the Optilume® Ureteric Drug-Coated Balloon. News release. Laborie Medical Technologies. October 28, 2025. Accessed November 4, 2025. https://www.prnewswire.com/news-releases/laborie-announces-first-procedures-in-endure-1-study-with-the-optilume-ureteric-drug-coated-balloon-302595778.html

2. EvaluatioN of Optilume Drug-Coated Balloon for the Endoscopic Treatment of UREteric Strictures (ENDURE1). ClinicalTrials.gov. Last updated September 29, 2025. Accessed November 4, 2025. https://clinicaltrials.gov/study/NCT07020520