TLC announced that patient enrollment of EXCELLENCE, the Phase III pivotal clinical trial for TLC599 in patients with osteoarthritis (OA) knee pain, has been completed. TLC599 is a non-opioid, proprietary BioSeizer® sustained release formulation of dexamethasone sodium phosphate (DSP) intended to manage OA pain for up to six months. In the Phase II, randomized, double-blinded, placebo-controlled clinical trial in patients with OA of the knee, TLC599 demonstrated statistically significant and clinically meaningful improvement in pain relief in both the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Visual Analog Scale (VAS) scores compared to placebo from Day 3 all the way through the end of the study at 24 weeks. Magnetic resonance imaging (MRI) evaluation of knee cartilage using the MRI Osteoarthritis Knee Score (MOAKS) instrument indicated that, comparing index to non-index knees, patients treated with TLC599 displayed relatively less cartilage loss than patients treated with placebo, suggesting there may be protection from cartilage degeneration by TLC599. The pattern of efficacy seen in the overall population was remarkably consistent between the various subgroups, which were categorized based on gender, age, Kellgren-Lawrence Grade, unilateral or bilateral pain, baseline VAS and WOMAC pain scores, and further confirm the potential therapeutic effects of TLC599. EXCELLENCE, the Phase III, multi-center, randomized, double-blind, placebo- and active comparator-controlled pivotal study, is evaluating the efficacy and safety of a single as well as a repeat dose of TLC599 12mg in approximately 500 patients with knee OA across 46 sites in the US and Australia.