dexamethasone sustained-release (TLC599) / Taiwan Liposome Company, Endo - LARVOL DELTA

Immediate response to intravitreal treatment for macular edema due to diabetes and retinal vein occlusion. (PubMed, Eur J Ophthalmol) - "Comparatively, steroid agents showed better immediate response to therapy than anti-VEGFs. Maximum reduction in central retinal thickness was seen following triamcinolone acetonide injection. Cystoid edema showed better immediate response than spongy retinal thickening."

Journal • Diabetes • Diabetic Retinopathy • Macular Edema • Metabolic Disorders • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion

Phase IIa, Randomized, Double Blinded, Placebo Controlled, Dose Finding Study for TLC599 in OA Patients (clinicaltrials.gov) - P2 | N=76 | Completed | Sponsor: Taiwan Liposome Company | Phase classification: P2a ➔ P2

Phase classification • Immunology • Osteoarthritis • Pain • Rheumatology

A Phase 2, Open Label, PK Study of TLC599 in Subject With Osteoarthritis of the Knee (clinicaltrials.gov) - P2 | N=102 | Completed | Sponsor: Taiwan Liposome Company | Recruiting ➔ Completed

Trial completion • Immunology • Osteoarthritis • Pain • Rheumatology

Episcleral Dexamethasone for Treatment of Macular Edema and Inflammatory Disorders of the Posterior Pole (clinicaltrials.gov) - P1 | N=2 | Active, not recruiting | Sponsor: Targeted Therapy Technologies, LLC | Unknown status ➔ Active, not recruiting | Trial completion date: Sep 2020 ➔ Sep 2024

Enrollment closed • Trial completion date • Inflammation • Macular Edema • Ocular Inflammation • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion

A Phase I Study of Episcleral Dexamethasone for Treatment of Macular Edema (clinicaltrials.gov) - P1 | N=1 | Active, not recruiting | Sponsor: Targeted Therapy Technologies, LLC | Unknown status ➔ Active, not recruiting | Trial completion date: Sep 2020 ➔ Sep 2024 | Trial primary completion date: Jun 2020 ➔ Sep 2024

Enrollment closed • Trial completion date • Trial primary completion date • Diabetes • Diabetic Macular Edema • Macular Edema • Metabolic Disorders • Ophthalmology

A Phase 3 Study of Repeat Injection of TLC599 in Osteoarthritis of the Knee: Benefits to 52 Weeks (ACR Convergence 2023) - "TLC599 demonstrated a benefit over placebo in ADP and WOMAC pain in patients with OA of the knee after a single injection that was sustained to 24 weeks.A second injection of TLC599 at Week 24 provided further benefit to Week 52. These results provide additional information about the benefits of repeat steroid injection in OA of the knee and suggest that TLC599 may provide prolonged benefit and offer an alternative treatment for the management of OA knee pain. Change from Injection 1 Baseline in Average Daily Pain (ADP) Score of Patients Who Received the First Injection through Week 24 (N=504) and Patients Who Received a Repeat Injection from Week 24 through Week 52 (N=297)"

Late-breaking abstract • P3 data • Endocrine Disorders • Immunology • Inflammation • Musculoskeletal Pain • Nephrology • Osteoarthritis • Pain • Renal Disease • Rheumatology

TLC to Present Phase 3 Data of TLC599 in Late-Breaking Abstracts Session at ACR (GlobeNewswire) - P3 | N=506 | EXCELLENCE (NCT04123561) | sponsor: Taiwan Liposome Company | "TLC BioSciences...announced that the Abstract Selection Committee of the American College of Rheumatology (ACR) has accepted TLC's late-breaking abstract on TLC599 for oral presentation at ACR Convergence 2023....On the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain scale, TLC599 was statistically superior at Week 12, the primary endpoint, and numerically superior to placebo at all time points through the first injection period. On the average daily pain (ADP) scale, TLC599 was numerically and statistically superior to placebo at all time points during the first injection period. Additionally, the reduction in ADP for TLC599 was statistically superior to the active comparator at Week 12."

Late-breaking abstract • P3 data • Immunology • Osteoarthritis • Pain • Rheumatology

A Phase 2, Open Label, PK Study of TLC599 in Subject With Osteoarthritis of the Knee (clinicaltrials.gov) - P2 | N=102 | Recruiting | Sponsor: Taiwan Liposome Company | Completed ➔ Recruiting | Trial completion date: Jun 2022 ➔ Nov 2023 | Trial primary completion date: Jun 2022 ➔ Nov 2023

Enrollment open • Trial completion date • Trial primary completion date • Immunology • Osteoarthritis • Pain • Rheumatology

A Phase 2, Open Label, PK Study of TLC599 in Subject With Osteoarthritis of the Knee (clinicaltrials.gov) - P2 | N=93 | Completed | Sponsor: Taiwan Liposome Company | Active, not recruiting ➔ Completed

Trial completion • Immunology • Osteoarthritis • Pain • Rheumatology

TLC Announces TLC599 Agreement with Endo (GlobeNewswire) - "TLC BioSciences...today announced that it has entered a commercialization agreement with Endo International plc...for rights in the United States to TLC599, a proprietary BioSeizer® sustained release injectable in Phase 3 development for the treatment of osteoarthritis pain....Under the terms of the agreement, signed with Endo’s subsidiary Endo Ventures Limited (EVL), TLC will primarily be responsible for the development of the product and EVL will primarily be responsible for obtaining regulatory approval and commercialization of the product in the United States. Upon receipt of regulatory approval, Endo will have exclusive rights to manufacture, market, sell and distribute the product in the United States. TLC will receive an upfront payment of $30 million and will be eligible to receive up to an additional $110 million based on the achievement of certain development, regulatory, and manufacturing milestones..."

Licensing / partnership • CNS Disorders • Osteoarthritis • Pain

A Phase 2, Open Label, PK Study of TLC599 in Subject With Osteoarthritis of the Knee (clinicaltrials.gov) - P2 | N=93 | Active, not recruiting | Sponsor: Taiwan Liposome Company | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Osteoarthritis • Pain • Rheumatology

EXCELLENCE: Extended and Controlled Release Liposomal Formulated Dexamethasone for Chronic Knee OA Pain (clinicaltrials.gov) - P3 | N=506 | Completed | Sponsor: Taiwan Liposome Company | Active, not recruiting ➔ Completed

Trial completion • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

A Phase 2, Open Label, PK Study of TLC599 in Subject With Osteoarthritis of the Knee (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: Taiwan Liposome Company | Trial completion date: Feb 2022 ➔ Jun 2022 | Trial primary completion date: Feb 2022 ➔ Jun 2022

Trial completion date • Trial primary completion date • Immunology • Osteoarthritis • Pain • Rheumatology

TLC BioSciences Announces Publication of TLC599 Phase II Results in Arthritis Research & Therapy (GlobeNewswire) - P2 | N=77 | NCT03005873 | Sponsor: Taiwan Liposome Company | "TLC BioSciences...today announced that detailed results of its TLC599 Phase 2 clinical trial in patients with osteoarthritis of the knee have been published in the peer-reviewed journal Arthritis Research & Therapy....The results demonstrated statistically significantly reduced pain scores and oral pain medication use for up to 6 months with TLC599....Results showed that TLC599 demonstrated statistically significantly greater reduction in WOMAC pain and function as well as VAS scores compared to placebo through 24 weeks. Acetaminophen use in the TLC599 group was statistically significantly lower than that of the placebo group at most time points."

P2 data • CNS Disorders • Osteoarthritis • Pain

TLC599 in patients with osteoarthritis of the knee: a phase IIa, randomized, placebo-controlled, dose-finding study. (PubMed, Arthritis Res Ther) - P2a | "In participants with symptomatic knee osteoarthritis, TLC599 is a well-tolerated treatment that reduces pain and improves function for up to 24 weeks, a longer duration than that reported for existing IA treatments."

Clinical • Journal • P2a data • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

Dexamethasone Sustained-Release Intracanalicular Insert for Control of Postoperative Inflammation After Pars Plana Vitrectomy. (PubMed, Clin Ophthalmol) - "To evaluate the safety and efficacy of a dexamethasone sustained-release intracanalicular insert (DII) (Dextenza Ocular Therapeutix, Inc., Bedford, MA) for control of inflammation and pain after pars plana vitrectomy (PPV) compared to standard topical steroid therapy. Overall, mean OCT CFT decreased in both groups; one patient had CME in the DII group, as compared to three in the topical steroid group (not statistically significant). The dexamethasone intracanalicular insert provided excellent safety and efficacy in control of postoperative inflammation following PPV in this retrospective case-matched study."

Journal • Immunology • Inflammation • Macular Edema • Ophthalmology • Pain

TLC Reports First Quarter 2021 Financial Results and Provides Business Update (GlobeNewswire) - "Continuous excellent progress in EXCELLENCE, the Phase III pivotal clinical trial of TLC599 in ~500 patients with symptomatic knee osteoarthritis. Over 440 patients have reached the 24-week timepoint...There has been no safety concerns or serious adverse events related to treatment...The United States Food and Drug Administration (FDA) has scheduled an End-of-Phase 2 meeting with TLC in June to discuss the development plan for TLC590. With the meeting, TLC hopes to obtain FDA’s input and reach an agreement on the design parameters of the proposed pivotal clinical studies that will be used to support the TLC590 NDA application."

FDA event • Trial status • CNS Disorders • Osteoarthritis • Pain

A Phase 2, Open Label, PK Study of TLC599 in Subject With Osteoarthritis of the Knee (clinicaltrials.gov) - P2; N=90; Recruiting; Sponsor: Taiwan Liposome Company; Active, not recruiting ➔ Recruiting

Clinical • Enrollment open • Immunology • Osteoarthritis • Pain • Rheumatology

TLC Reports Fiscal Year End 2020 Financial Results and Provides Business Update (GlobeNewswire) - "...the completion of patient enrollment, 504 patients have received their first injection of TLC599, dexamethasone sodium phosphate or normal saline in EXCELLENCE, the Phase III pivotal clinical trial of TLC599 for symptomatic knee osteoarthritis...planned End-of-Phase-2 meetings to occur in 2021 with the United States Food and Drug Administration (FDA) on the design of the clinical trials and production preparations."

Enrollment closed • FDA event • CNS Disorders • Osteoarthritis • Pain

EXCELLENCE: Extended and Controlled Release Liposomal Formulated Dexamethasone for Chronic Knee OA Pain (clinicaltrials.gov) - P3; N=500; Active, not recruiting; Sponsor: Taiwan Liposome Company; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

TLC Announces Full Patient Enrollment in EXCELLENCE Trial of TLC599 for Osteoarthritis Pain (GlobeNewswire) - "TLC...announced today that patient enrollment of EXCELLENCE, the Phase III pivotal clinical trial for TLC599 in patients with osteoarthritis (OA) knee pain, has been completed; On-schedule completion of enrollment despite COVID-19 pandemic; unique trial design evaluates safety and efficacy of single & repeat doses."

Enrollment closed • CNS Disorders • Osteoarthritis • Pain

TLC Provides Corporate Update at Investor Conference (GlobeNewswire) - "Patient enrollment of EXCELLENCE, the Phase III pivotal study of TLC599 for symptomatic knee osteoarthritis, is at 98%. The trial remains on-track to complete enrollment of all 500 patients in the United States and Australia before the end of 2020...Topline data of TLC’s leading program is expected in the second half of 2021. Preparations for pivotal studies of TLC590 for postsurgical pain management are currently underway....TLC is arranging discussions with the United States Food and Drug Administration (FDA) regarding the design of the pivotal clinical trials. In addition, TLC is preparing for scale-up production of TLC590...and New Drug Application submission must be the same as future commercial batches."

Enrollment status • New trial • P3 data: top line • CNS Disorders • Osteoarthritis • Pain

TLC Reports Third Quarter 2020 Financial Results and Provides Business Update (GlobeNewswire) - "TLC...today announced financial results for the third quarter ending September 30, 2020, and provided a business update....Clinical Pipeline Update and Upcoming Milestones:...~80% enrollment complete in EXCELLENCE, the Phase III, multi-center, randomized, double-blind, placebo- and active comparator- controlled pivotal study evaluating the efficacy and safety of both a single and a repeated dose of TLC599 for symptomatic knee osteoarthritis. EXCELLENCE remains on-track to complete enrollment of all 500 patients before the end of 2020, with topline data expected in late 2021."

Enrollment status • P3 data: top line • CNS Disorders • Osteoarthritis • Pain

TLC to Present at Oppenheimer Fall Healthcare Life Sciences & Med Tech Summit (GlobeNewswire) - "TLC...today announced that President Mr. George Yeh and Chief Medical Officer Dr. George Spencer-Green, MD, will be presenting at Oppenheimer Fall Healthcare Life Sciences & Med Tech Summit on Wednesday, September 23, 2020 at 9:10am ET. The 40-minute live presentation will include...analyses of data on TLC’s pain programs – TLC599 and TLC590 – by Dr. Spencer-Green. During the virtual conference, which takes place September 21-23, 2020, TLC will also be participating in one-on-one sessions."

Live event • CNS Disorders • Osteoarthritis • Pain

TLC to Present at Cantor Virtual Global Healthcare Conference (GlobeNewswire) - "TLC...today announced that George Yeh, President of TLC, will be discussing recent activities regarding the company in a fireside chat with Kristen Kluska, Research Analyst, at Cantor Virtual Global Healthcare Conference on Tuesday, September 15, 2020 at 10:00am ET. The 30-minute fireside chat will be a Q&A session in which Mr. Yeh will introduce TLC and talk about the company’s leading programs: TLC599 for sustained relief of osteoarthritis pain and TLC590 for sustained relief of postsurgical pain, and introduce TLC19 for prevention and treatment of COVID-19."

Live event • CNS Disorders • Osteoarthritis • Pain