- Met Primary Endpoint: Significant pain reduction through 72 hours vs. placebo.
- Significantly Reduced Opioid Use: Outperformed both placebo and liposomal bupivacaine head-to-head in pain reduction and opioid consumption.
- Prolonged Efficacy: A single dose sustained significant pain relief versus both comparators through 7 days.
TAIPEI, Taiwan and SOUTH SAN FRANCISCO, Calif., Oct. 19, 2026 (GLOBE NEWSWIRE) -- TLC BioSciences Corp. (TPEx: TLC-KY; ticker: 7924; “TLC”) today announced positive topline 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 met its primary endpoint, with TLC590 significantly reducing pain intensity through 72 hours after surgery compared with placebo (p=0.0024); rescue opioid consumption was also significantly lower. In a head-to-head comparison with liposomal bupivacaine, an approved long-acting local anesthetic, TLC590 also demonstrated statistically significant superiority in both pain intensity and rescue opioid consumption. The analgesic benefit of TLC590 over both comparators was maintained through 168 hours. These results support the potential of TLC590 as a single-dose, non-opioid option for durable postsurgical pain relief with reduced opioid use.
Compared with placebo, TLC590 significantly reduced cumulative pain intensity with movement through 72 hours after surgery (NRS-M AUC0–72h; p=0.0024), meeting the primary endpoint, and significantly reduced total rescue opioid consumption over the same period (p=0.0109).
In the head-to-head comparison with liposomal bupivacaine, TLC590 demonstrated statistically significant superiority in cumulative pain intensity through 72 hours (NRS-M AUC0–72h; p=0.0202), and significantly reduced rescue opioid consumption (p=0.0177).
Over the extended 168-hour assessment period, TLC590 maintained a statistically significant reduction in cumulative pain intensity versus both placebo (NRS-M AUC0–168h; p=0.0168) and liposomal bupivacaine (p=0.0226).
“This Phase 3 success is a transformative milestone for TLC and a potential paradigm shift in postsurgical care,” said George Yeh, Chief Executive Officer of TLC BioSciences. “Addressing the opioid crisis requires treatments that deliver robust pain relief while actively reducing opioid dependence. By demonstrating a clear clinical advantage over the current commercial standard of care, TLC590 has proven it can do exactly that. With this highly de-risked clinical profile, our team is fully focused on advancing our NDA and bringing this critical non-opioid option to patients and providers as efficiently as possible.”
“There remains a significant need for non-opioid options that provide durable analgesia beyond the first few days after surgery,” said David Leiman, MD, MBA, President, Acute and Chronic Pain, at Evolution Research Group, and an investigator in the TLC590 Phase 3 trial. “I am highly encouraged by these results. Demonstrating statistically significant superiority over both placebo and liposomal bupivacaine, with a treatment effect sustained through 168 hours from a single dose, is a meaningful achievement in the well-established bunionectomy model. These data suggest that TLC590 has the potential to provide sustained pain control through the critical first postoperative week while reducing reliance on opioids.”
Next Steps: NDA Preparation and Commercialization
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.
About the TLC590 Phase 3 Trial
This randomized, double-blind, placebo- and active-controlled Phase 3 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.
Dawn Chi / Corporate Communications / dawn@tlcbio.com
