Urotronic Urethral Stricture Device Approved for Pivotal Phase 3 Trial

Urotronic Inc. has gotten the green light for a pivotal phase 3 clinical trial.

The US Food and Drug Administration (FDA) has granted approval to the Minneapolis-based early-stage medical device company to begin its second US study of the Optilume Drug Coated Balloon (DCB) catheter for the treatment of men with urethral strictures.

The trial (Robust III) will include 200 enrolled men from 20 clinical facilities across the country, and will begin immediately. It follows the first FDA-approved US trial for DCB — an Early Feasibility Study which began in November 2017 and is currently underway in another 5 US medical centers.

Urethral strictures block the pathway for urine to exit the body via the bladder, and is characterized by significantly painful symptoms. They are often caused by infections, trauma, or medical procedures that injure the lining of the urethra. Scar tissue which develops during healing eventually narrows the tube by which urine leaves the body.

The need for catheter devices for men suffering from such conditions is a dire one. Approximately 1 in every 5 men develop a urinary stricture, with urological procedures pertaining to the treatment anticipated to skyrocket with the aging of the baby boomer generation. As of right now, there are about 1.5 million doctor visits in the US that are to address urethral stricture treatment.

The device functions by pairing mechanical dilation with drug therapy to provide a simplified outpatient procedure method of care.

Sean Elliott, principal investigator of the Robust trials and vice chair of Urology from the University of Minnesota, said in a statement that physicians are looking for technology that is “minimally invasive and also curative.”

“The Optilume drug coated balloon has the potential to decrease the rate of recurrence and provide physicians and their patients better outcomes based on early clinical results,” Elliott said.

In this most recent DCB pivotal trial, patients will be randomized to receive Optilume DCB or the current standard of care, based on physician preference. It is backed by early results from Robust I, an initial study established in Latin America. The results showed that the device reported significant improvements in patient symptom scores and urinary flow rates — reaching its primary and secondary clinical endpoints.

Ramon Virasoro, MD, co-principal investigator of ROBUST III and a Robust study physician from Eastern Virginia Medical Center, noted that patient quality of life symptom scores improved by 70% or higher at 3, 6, and 12 months, and peak urinary flow rates improved 17ml/second at 3 months, with continued improvement through 12 months.

David Perry, president and chief executive officer of Urotronic, said the company is honored to provide urologists and patients a solution to stricture recurrence.

“We hope to repeat the compelling clinical results from our ROBUST I Latin America study with the pending US Pivotal study, and demonstrate a minimally invasive treatment option that can be performed in a variety of clinical settings, including as an in-office procedure,” Perry said.