The Food and Drug Administration (FDA) has approved the Optilume® Urethral Drug Coated Balloon (DCB) to treat patients with obstructive urinary symptoms associated with anterior urethral stricture. The device is designed to be used in adult males for urethral stricture of 3cm or less in length.
The Optilume DCB is an over-the-wire guidewire compatible catheter that includes a balloon coated with paclitaxel, an antimitotic agent that has been shown to inhibit smooth muscle cell and fibroblast proliferation and migration. Once inflated, the balloon dilates the urethra to improve urine flow, and paclitaxel is transferred to the urethra wall to inhibit stricture recurrence.
The approval was based on data from the ROBUST 3 study (ClinicalTrials.gov Identifier: NCT03499964), which evaluated the safety and efficacy of the Optilume DCB compared with endoscopic management of recurrent anterior urethral strictures (standard of care). Findings showed that the Optilume DCB was statistically superior to standard of care endoscopic management in maintaining freedom from stricture recurrence through 6 months post treatment (P <.001). None of the patients experienced a primary safety endpoint event, defined as a serious complication at 3 months such as fistula formation, unresolved de novo stress urinary incontinence or urethral rupture or burst.
The application also included data from the ROBUST I study, which showed evidence of effectiveness through 3 years post treatment. “At 3 years, durability continued with a 77% freedom from reintervention rate, a 176% increase in [maximum flow rate], and a 65% decrease in [International Prostate Symptom Score],” said Dr Sean Elliott, principal investigator for the Re-establishing Flow Via Drug-Coated Balloon for the Treatment of Urethral Stricture Disease (ROBUST) trials. “Optilume may serve as an important alternative for men with recurrent strictures that want to avoid or delay urethroplasty.”
- FDA approves Optilume® Urethral Drug Coated Balloon, a breakthrough treatment for urethral strictures. News release. December 13, 2021. https://www.prnewswire.com/news-releases/fda-approves-optilume-urethral-drug-coated-balloon-a-breakthrough-treatment-for-urethral-strictures-301442655.html.
- Urotronic-Optilume Summary of Safety and Effectiveness Data. Accessed December 13, 2021. https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210020B.pdf.