Durolane (sodium hyaluronate) / Bioventus - LARVOL DELTA

KOALA: Knee OsteoArthritis Long-term Assessment (clinicaltrials.gov) - P=N/A | N=226 | Not yet recruiting | Sponsor: Allegro NV/SA | N=99 ➔ 226 | Trial completion date: Mar 2026 ➔ Jun 2026 | Trial primary completion date: Mar 2026 ➔ Jun 2026

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

Foreign body giant cell reaction due to Durolane (hyaluronic acid derivative) injection - A case report. (PubMed, Skeletal Radiol) - "The manifestation of a foreign body giant cell reaction after Durolane injection, mimicking malignant osseous lesions, merits attention among practitioners. This case underscores the necessity for further research into potential adverse reactions associated with hyaluronic acid derivatives."

Journal • Hematological Malignancies • Immunology • Multiple Myeloma • Oncology • Osteoarthritis • Pain • Rheumatology

Bioventus Agrees to Nationwide Contract with Aetna Medicare Advantage Plans for DUROLANE for Knee Osteoarthritis (GlobeNewswire) - "Bioventus Inc...has agreed to a nationwide contract with Aetna™ Medicare Advantage plans. Beginning January 1, 2024, over 3 million Aetna™ Medicare Advantage plan members will have access to DUROLANE to treat knee osteoarthritis (OA) pain."

Reimbursement • CNS Disorders • Osteoarthritis • Pain

Efficacy and Safety of Intra-Articular Cross-Linked Sodium Hyaluronate for the Treatment of Knee Osteoarthritis: A Prospective, Active-Controlled, Randomized, Parallel-Group, Double-Blind, Multicenter Study. (PubMed, J Clin Med) - "The safety and efficacy of Hyruan ONE (test product), an intra-articular cross-linked sodium hyaluronate injection, to treat mild-to-moderate knee osteoarthritis was compared with that of Durolane (comparator) in a prospective, active-controlled, parallel-group, double-blind (masked-observed), multicenter non-inferiority study...In both groups, most treatment-emergent adverse events were mild/moderate. Hyruan ONE was non-inferior to the comparator at 13 weeks post-injection in European patients with mild-to-moderate knee osteoarthritis."

Clinical • Journal • Immunology • Osteoarthritis • Pain • Rheumatology

Comparative Assessment of Intra-articular Knee Injections of Platelet-rich Plasma (PRP) and Hyaluronic Acid in the Treatment of Knee Osteoarthritis (clinicaltrials.gov) - P2 | N=58 | Completed | Sponsor: Assistance Publique Hopitaux De Marseille | Unknown status ➔ Completed

Trial completion • Immunology • Osteoarthritis • Pain • Rheumatology

Single Injection of Cross-Linked Hyaluronate in Knee Osteoarthritis: A 52-Week Double-Blind Randomized Controlled Trial. (PubMed, Pharmaceutics) - "While a single injection of either HJP or Durolane is safe and effective for at least 52 weeks, HJP provided superior improvement in terms of VAS pain and stiffness scores, WOMAC pain and stiffness scores, and satisfaction score within 39 weeks of treatment."

Journal • Immunology • Osteoarthritis • Pain • Rheumatology

Bioventus Agrees to Nationwide Contract with Cigna Commercial Plans for DUROLANE® and GELSYN-3® for Knee Osteoarthritis (GlobeNewswire) - "Bioventus Inc...has agreed to a nationwide contract with Cigna® commercial plans. Beginning July 1, 2022, Cigna® commercial plan members will have access to both DUROLANE and GELSYN-3, to treat knee osteoarthritis (OA) pain. DUROLANE, is a single-injection and GELSYN-3, is a three-injection hyaluronic acid (HA)-based joint-fluid treatment for patients. Durolane will be exclusive to all Cigna patients while Gelsyn-3 will be one of two multi-injection HA products under contract."

Licensing / partnership • CNS Disorders • Musculoskeletal Diseases • Osteoarthritis • Pain

"$BVS Bioventus Agrees to Nationwide Contract with Cigna Commercial Plans for DUROLANE® and GELSYN-3® for Knee Osteoarthritis https://t.co/6BbyrMTYZQ" (@stock_titan)

Immunology • Osteoarthritis • Pain • Rheumatology

To Assess the Safety and Effectiveness of Hyruan ONE Versus a Comparator for the Treatment of Knee Osteoarthritis in Europe (clinicaltrials.gov) - P=N/A | N=284 | Completed | Sponsor: LG Chem | Active, not recruiting ➔ Completed

Trial completion • Immunology • Osteoarthritis • Pain • Rheumatology

Durolane SJ for Treatment of Rhizarthrosis (clinicaltrials.gov) - P=N/A; N=36; Completed; Sponsor: Zambon SAU; Phase classification: P4 ➔ P=N/A

Clinical • Phase classification • Osteoarthritis

To Assess the Safety and Effectiveness of Hyruan ONE Versus a Comparator for the Treatment of Knee Osteoarthritis in Europe (clinicaltrials.gov) - P=N/A; N=284; Active, not recruiting; Sponsor: LG Chem; Recruiting ➔ Active, not recruiting; Trial completion date: Jun 2021 ➔ Dec 2021

Clinical • Enrollment closed • Trial completion date • Immunology • Osteoarthritis • Pain • Rheumatology

A Comprehensive Review of Viscosupplementation in Osteoarthritis of the Knee. (PubMed, Orthop Rev (Pavia)) - "Current treatment options include Hylan g-f-20, Sodium Hyaluronate preparations (Suparts Fx, Euflexxa, Gelsyn-3, Durolane, Hyalgen), single-use agents (Gel-One, Synvisc-One, Monovisc), and Hyaluronan (Orthovisc, Monovisc, Hymovic). VS effectively reduces pain, increases functionality, and delays surgery in the knee to treat osteoarthritis. While previous studies have demonstrated variable results, more evidence is becoming available generally supportive of the benefit of VS in the treatment of knee OA."

Journal • Review • Immunology • Inflammation • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology • NFKB1

Long-Term Outcome Measures of Repeated Non-Animal Stabilized Hyaluronic Acid (Durolane) Injections in Osteoarthritis: A 6-Year Cohort Study with 623 Consecutive Patients. (PubMed, Open Access Rheumatol) - "Patients who received subsequent 3rd, 4th, and 5th injections also experienced extended duration of benefit. Patients with grades 2 or 3 osteoarthritis are more likely to experience a longer duration of relief."

Journal • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

DUROLANE Among High-Molecular Weight Hyaluronic Acid Treatments Linked to Significant Improvements in Knee Osteoarthritis Pain by American Academy of Orthopaedic Surgeons (GlobeNewswire) - "Bioventus...announced that the American Academy of Orthopaedic Surgeons (AAOS) recently released updated clinical practice guidelines (CPG) indicating that high molecular weight cross-linked hyaluronic treatments, including Bioventus treatment DUROLANE, showed statistically significant improvement in certain knee osteoarthritis (OA) patients....'The updated clinical practice guidelines from AAOS better aligns with the clinical practice and experience of most physicians. HA injections, including DUROLANE, are a viable option for patients who fail treatments such as NSAID’s, weight loss, and exercise,'..."

Clinical guideline • CNS Disorders • Osteoarthritis • Pain

Safety and efficacy of a single intra-articular injection of hyaluronic acid in osteoarthritis of the hip: a case series of 87 patients. (PubMed, BMC Musculoskelet Disord) - "A single injection of HA (NASHA) in the setting of hip joint OA was both safe and efficacious in this 87 patient cohort. Improvement in pain and function as measured with mHHS was statistically significant and reached the MCID of 10."

Clinical • Journal • Immunology • Osteoarthritis • Pain • Rheumatology

Intraarticular Hyaluronic Acid Preparations for Knee Osteoarthritis: Are Some Better Than Others? (PubMed, Cartilage) - "IAHA efficacy varies widely across preparations. High-quality studies are required to assess and compare the safety and efficacy of IAHA preparations."

Journal • Immunology • Osteoarthritis • Pain • Rheumatology

Comparative Study of Safety and Efficacy of Two Hyaluronic Acids for the Treatment of Knee Osteoarthritis Pain (clinicaltrials.gov) - P=N/A; N=349; Completed; Sponsor: Bioventus LLC; Phase classification: P3 ➔ P=N/A

Phase classification • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

ENKORE: Efficacy and Safety of a Intra-articular Injection, ENKO1, in Patients With Symptomatic Knee Osteoarthritis. (clinicaltrials.gov) - P=N/A; N=175; Completed; Sponsor: OPKO Health, Inc.; Recruiting ➔ Completed; Trial completion date: Dec 2020 ➔ May 2020

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

Prospective Single Center Open Label Study of Shoulder OA Pain (clinicaltrials.gov) - P=N/A; N=41; Completed; Sponsor: Bioventus LLC; Recruiting ➔ Completed

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

To Assess the Safety and Effectiveness of Hyruan ONE Versus a Comparator for the Treatment of Knee Osteoarthritis in Europe (clinicaltrials.gov) - P=N/A; N=284; Recruiting; Sponsor: LG Chem; Not yet recruiting ➔ Recruiting

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

To Assess the Safety and Effectiveness of Hyruan ONE Versus a Comparator for the Treatment of Knee Osteoarthritis in Europe (clinicaltrials.gov) - P=N/A; N=284; Not yet recruiting; Sponsor: LG Chem

Clinical • New trial • Immunology • Osteoarthritis • Pain • Rheumatology

[VIRTUAL] Evaluating the use of viscosupplementation for osteoarthritic knee pain in a health system (ASHP 2020) - "The products that the patients received included: Euflexxa, Hyalgan/Supartz, Gelsyn, Synvisc/Synvisc-One, Durolane, and Orthovisc. Patients from the population also could have received Gel-One, Hymovis, or Monovisc injections, but the number of patients receiving these products was less than twenty... There are six viscosupplementation products being used in the health system. When data from the various products was pooled together, less than half of patients noted at least moderate benefit from viscosupplementation. While the injections were shown to be very well tolerated, the lack of widespread benefit fell in line with AAOS not recommending viscosupplementation for osteoarthritic knee pain."

Immunology • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Osteoarthritis • Osteoporosis • Pain • Rheumatology

Bioventus to Provide CVS Caremark with its Portfolio of Preferred Options for Knee Osteoarthritis Patients Seeking Pain Relief (Businesswire) - "Beginning January 1, 2021 Bioventus, a global leader in Innovations For Active Healing, will gain preferred access through the CVS Caremark Formulary, to DUROLANE®, GELSYN-3® and SUPARTZ FX®, for the treatment of knee osteoarthritis (OA) pain."

Reimbursement • CNS Disorders • Osteoarthritis • Pain

Bioventus Reaches Milestone with 2 Million DUROLANE Treatments Worldwide (Businesswire) - "Bioventus...is celebrating a milestone and recognizing more than 2 million treatments worldwide with DUROLANE, its single-injection, hyaluronic acid (HA) product used in the treatment of pain associated with osteoarthritis (OA)."

Commercial • Musculoskeletal Diseases • Osteoarthritis • Pain

Bioventus selects Bazis NN as distributor of DUROLANE in Russia (Businesswire) - "Bioventus...has selected Bazis NN as its authorized distributor for DUROLANE, its single-injection joint-fluid osteoarthritis (OA) treatment. OA involves the breakdown, or degeneration, of cartilage and the synovial fluid that cushions and lubricates joint tissues."

Commercial • Musculoskeletal Diseases • Osteoarthritis • Pain