TLC BioSciences Completes Last Patient Visit in Phase 3 Trial of TLC590 for Postsurgical Pain

Pivotal 304-patient U.S. study of the investigational non-opioid analgesic moves to data analysis; topline results expected in the near term TLC BioSciences Corp. (“TLC”; TPEx: TLC-KY, stock code: 7924), a late-clinical-stage biotechnology company advancing lipid-based drug delivery technologies, today announced Last Patient Last Visit (LPLV) in its pivotal Phase 3 clinical trial of TLC590, an investigational non-opioid extended-release analgesic for postsurgical pain. The study will now proceed to database lock and data analysis, with topline results expected in the near term. TLC590 is TLC’s proprietary BioSeizer® ropivacaine extended-release injectable suspension, designed to provide rapid onset and sustained analgesia from one administration. The randomized, double-blind Phase 3 trial enrolled 304 adults undergoing bunionectomy at U.S. sites and compares a single dose of TLC590 with liposomal bupivacaine and placebo. The study evaluates postsurgical pain relief and TLC590’s potential to reduce opioid use. TLC590’s clinical development strategy has consistently benchmarked the treatment against current standards of care for postsurgical pain. In earlier clinical studies, TLC590 was compared with ropivacaine and bupivacaine and demonstrated analgesic effects through 168 hours, along with reduced opioid use and a favorable tolerability profile. The pivotal Phase 3 trial further extends this approach by comparing TLC590 with liposomal bupivacaine, a leading market standard, to help define its clinical positioning. “Completing all patient visits brings us closer to topline Phase 3 data,” said George Yeh, Chief Executive Officer of TLC BioSciences. “Patients need pain relief that lasts from a single administration without relying on opioids. A positive readout would further support TLC590 as a differentiated, opioid-sparing option and strengthen our broader pain franchise.” More than 300 million surgical procedures are performed worldwide each year, and more than 80% of patients report acute postsurgical pain. Future Market Insights projects the global postoperative pain market will grow from $42.5 billion in 2025 to $70.6 billion by 2035. In the United States, where an estimated 42 million procedures are performed annually, the NOPAIN Act provides separate Medicare payment for qualifying FDA-approved non-opioid postsurgical treatments in outpatient surgical settings; TLC590 would be eligible if approved.

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