TLC590 Shows Statistically Significant Pain Relief and Reduced Opioid Use

TAIPEI, Taiwan and SOUTH SAN FRANCISCO, Calif., Oct. 19, 2026 /CourierPR/ -- TLC BioSciences Corp. (TPEx: TLC-KY; ticker: 7924; “TLC”) today announced positive results from its pivotal Phase 3 trial of TLC590, an investigational extended-release formulation of ropivacaine, for the management of postsurgical pain following bunionectomy. The trial, conducted in the United States, involved 304 patients who were randomly assigned to receive TLC590 (n=100), liposomal bupivacaine (n=102), or placebo (n=102).

The primary endpoint of the trial was met, with TLC590 significantly reducing pain intensity through 72 hours after surgery compared with placebo. Specifically, TLC590 significantly reduced cumulative pain intensity with movement through 72 hours (NRS-M AUC0-72h; p=0.0024). Additionally, TLC590 significantly reduced total rescue opioid consumption over the same period (p=0.0109).

In a head-to-head comparison with liposomal bupivacaine, an approved long-acting local anesthetic, TLC590 demonstrated statistically significant superiority in both pain intensity and rescue opioid consumption. TLC590 significantly reduced cumulative pain intensity through 72 hours (NRS-M AUC0-72h; p=0.0202) and significantly reduced rescue opioid consumption (p=0.0177).

The analgesic benefit of TLC590 was maintained over the extended 168-hour assessment period. TLC590 showed a statistically significant reduction in cumulative pain intensity versus both placebo (NRS-M AUC0-168h; p=0.0168) and liposomal bupivacaine (p=0.0226).

These topline results, particularly the superiority demonstrated over liposomal bupivacaine, provide a strong clinical foundation and clear differentiation for TLC590 in the postsurgical pain market. TLC will complete the full data analysis and clinical study report, advance preparations for a New Drug Application (NDA) submission to the US FDA, and prepare for the commercialization of TLC590, with the goal of making it available to postsurgical patients as quickly as possible.

The trial evaluated the efficacy and safety of TLC590 for postsurgical pain management in 304 patients undergoing bunionectomy in the United States. Patients were assigned 1:1:1 to receive TLC590 (n=100), liposomal bupivacaine (n=102), or placebo (n=102). The primary efficacy endpoint was the area under the curve of numeric rating scale pain intensity scores with movement through 72 hours after surgery (NRS-M AUC0-72h) for TLC590 versus placebo. Secondary efficacy endpoints included total rescue opioid consumption through 72 hours for TLC590 versus placebo, and comparisons of TLC590 with liposomal bupivacaine on both measures. A key efficacy endpoint evaluated NRS-M AUC through 168 hours (AUC0-168h) for TLC590 versus both control groups.

TLC590 was generally well tolerated, with a safety profile comparable to placebo and liposomal bupivacaine. There were no drug-related serious adverse events or discontinuations due to drug-related adverse events in TLC590-treated patients.

The results of this Phase 3 trial support the potential of TLC590 as a single-dose, non-opioid option for durable postsurgical pain relief with reduced opioid use. TLC BioSciences is now focused on completing the full data analysis and preparing for the submission of a New Drug Application (NDA) to the US FDA. The company aims to bring this critical non-opioid option to patients and providers as quickly as possible, addressing the ongoing challenge of opioid dependence in postsurgical care.