Monovisc (sodium hyaluronate) / Anika Therap - LARVOL DELTA

Comparative Study of Two Hyaluronic Acid Formulation in the Management of Knee Osteoarthritis (clinicaltrials.gov) - P=N/A | N=350 | Completed | Sponsor: Fidia Farmaceutici s.p.a.

New trial • Immunology • Osteoarthritis • Pain • Rheumatology

Anika Reports First Quarter 2024 Financial Results (GlobeNewswire) - "Extended exclusive distribution agreement with our established Canadian commercial partner, Pendopharm, to sell Cingal, Monovisc and Orthovisc through 2030, building on the existing market leadership position in Canada."

Licensing / partnership • CNS Disorders • Osteoarthritis • Pain

Trial Comparing Three Single Dose Injections for Knee Osteoarthritis (clinicaltrials.gov) - P4 | N=6 | Terminated | Sponsor: Ohio State University | Potential participants are unwilling to participate in the study due to the randomziation and blinding. Both aspects are needed to ensure a robust comparison between groups.

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

Joint Lubricants As Delivery Methods For Multipotent Stromal Cells (OARSI 2023) - "While MSCs could be delivered in these uncrosslinked gels, it is hypothesized that they will not trap the cells in the knee joint long enough to have an effect. The aims of this study were: 1) to determine whether a commercial HA joint lubricant (Monovisc) could maintain MSC viability under different conditions, and 2) to determine the ability of cells delivered in Monovisc to reverse knee joint degeneration in an OA rat model."

Stroma • Bone Marrow Transplantation • Immunology • Musculoskeletal Diseases • Osteoarthritis • Pain • Rheumatology • Transplantation

Effect of Different Injection Regimens of Autologous Conditioned Plasma for Knee Osteoarthritis (clinicaltrials.gov) - P2/3 | N=60 | Completed | Sponsor: Andrews Research & Education Foundation | Active, not recruiting ➔ Completed

Trial completion • Immunology • Osteoarthritis • Pain • Rheumatology

Trial Comparing Three Single Dose Injections for Knee Osteoarthritis (clinicaltrials.gov) - P4 | N=165 | Recruiting | Sponsor: Ohio State University

New P4 trial • Immunology • Osteoarthritis • Pain • Rheumatology

Effect of Different Injection Regimens of Autologous Conditioned Plasma for Knee Osteoarthritis (clinicaltrials.gov) - P2/3 | N=60 | Active, not recruiting | Sponsor: Andrews Research & Education Foundation | Enrolling by invitation ➔ Active, not recruiting | Trial completion date: Dec 2021 ➔ Dec 2022 | Trial primary completion date: Jun 2021 ➔ Aug 2022

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

Knee Post Meniscal Surgery - Soccer (ACSM 2022) - "RICE + Monovisc viscosupplementation and 2 corticosteroid injectionsAt 1-year follow-up, athlete maintains play at professional level with minimal pain and effusion. Right knee MRI:• Mild degenerative thinning of lateral tibiofemoral cartilage• Moderate joint swelling, compatible with a synovitis• Tibial plateau deep cartilage fissures and mild bone marrow edema, progression of chondropathyKnee kinesiography (3D knee dynamic functional gait assessment):• Stiff knee gait, a protective mechanism characterized by the knee locked in extension during loading and stance demonstrating loading /absorption dysfunction• Static valgus alignment increased dynamically during loading phase and maintained during stance phase of gait demonstrating increased load on lateral compartmentFINAL WORKING DIAGNOSIS:1. Mild osteoarthritis of the lateral compartment2. Mild synovitisTREATMENT AND OUTCOMES:1."

Immunology • Musculoskeletal Pain • 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

Risk of Severe Acute Localized Reactions for Different Intraarticular Hyaluronic Acid Knee Injections in a Real-World Setting. (PubMed, Cartilage) - "Case reports of severe acute localized reactions (SALR) following intraarticular (IA) hyaluronic acid (HA) injections for knee osteoarthritis (OA) have been described. Among the single injection products, Hylan G-F 20 (6 mL) single injection had lower rates of SALR than Monovisc and Gel-One. This study shows no clear correlation between avian-derived or cross-linked products and SALR and provides evidence against avian-derived products or crosslinking as a source for these reactions."

Clinical • Journal • Real-world evidence • Immunology • Infectious Disease • Inflammation • Orthopedics • 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

MONOVISC for Shoulder Joint Pain Relief (clinicaltrials.gov) - P=N/A; N=25; Completed; Sponsor: Anika Therapeutics, Inc.; Recruiting ➔ Completed

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

MONOVISC for Ankle Joint Pain Relief (clinicaltrials.gov) - P=N/A; N=25; Completed; Sponsor: Anika Therapeutics, Inc.; Recruiting ➔ Completed

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

MONOVISC for Hip Joint Pain Relief (clinicaltrials.gov) - P=N/A; N=25; Completed; Sponsor: Anika Therapeutics, Inc.; Recruiting ➔ Completed

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

MONOVISC for Shoulder Joint Pain Relief (clinicaltrials.gov) - P=N/A; N=25; Recruiting; Sponsor: Anika Therapeutics, Inc.; Trial primary completion date: Jun 2020 ➔ Feb 2021

Clinical • Trial primary completion date • Immunology • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Osteoarthritis • Pain • Rheumatology

MONOVISC for Hip Joint Pain Relief (clinicaltrials.gov) - P=N/A; N=25; Recruiting; Sponsor: Anika Therapeutics, Inc.; Trial primary completion date: Jun 2020 ➔ Feb 2021

Clinical • Trial primary completion date • Immunology • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Osteoarthritis • Pain • Rheumatology

MONOVISC for Ankle Joint Pain Relief (clinicaltrials.gov) - P=N/A; N=25; Recruiting; Sponsor: Anika Therapeutics, Inc.; Trial primary completion date: Jun 2020 ➔ Feb 2021

Clinical • Trial primary completion date • Immunology • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • 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

[VIRTUAL] Risk of Severe Acute Localized Reactions for Different Intra-Articular Hyaluronic Acid Knee Injections in a Real World Setting (ACR-ARHP 2020) - "Inflammation/infection rate (with any diagnosis) was rare within three days of HA use (hylan G-F 20 (3-injection): 0.02%; Euflexxa: 0.03%; Hyalgan/Supartz: 0.02%; Orthovisc: 0.02%; hylan G-F 20 (1-injection): 0.02%; Monovisc: none; Gel-One: none) (Figs. The present study examined potential SALR risk in a real-world setting of almost 700,000 HA injections. Diagnoses of inflammation or infection diagnoses were extremely rare (0 to 0.03%) within three days of HA injections. While our arthrocentesis results are consistent with a randomized controlled trial (Kirchner 2006), which reported a greater rate of local reactions in terms of effusions, in hylan G-F 20 (3-injection) than Euflexxa patients, the collective risk of any of the surrogate SALR outcomes was not found to be significantly different between hylan G-F 20 and non-hylan G-F 20 products (single or multiple injection products)."

Clinical • Real-World Evidence • Allergy • Immunology • Inflammation • Orthopedics • Osteoarthritis • Pain • Rheumatology

Anika Therapeutics: After A Stormy Period, Orthopedic Specialist Looks Set Fair (SeekingAlpha) - "Anika has commercialized more than 20 products derived from its hyaluronic acid technology platform. Its joint pain management business - consisting of viscosupplements MONOVISC, ORTHOVISC, and CINGAL - earns the company ~75% of all its revenues. The stock plummeted 66% from Dec 19-Mar 20 but has gained slightly on top (19%) & bottom (16%) line sequential revenue growth in Q120 + FY19 revenues up 9% to $115m."

Commercial • CNS Disorders • Osteoarthritis • Pain

The Effect of a Single Hyaluronic Acid Injection in Ankle Arthritis - A Prospective Cohort Study. (PubMed, J Foot Ankle Surg) - "A single intra-articular injection of Cingal or MonoVisc was administered. Subgroup analysis on arthrosis grade (grade I-II and III-IV) showed no statistically significant changes for all variables even though patients with grade III-IV arthrosis seemed to benefit more from the treatment. The results indicate that a single injection of hyaluronic acid is insufficient to produce at clinically relevant response after 6 months even though there is a high risk of underpowering because of a small patient population."

Clinical • Journal • Immunology • Osteoarthritis • Pain • Rheumatology

Anika Therapeutics : Management's discussion and analysis of financial condition and results of operations (amounts in thousands, except per share amounts or as otherwise noted) (form 10-Q) (Market Screener) - ".We are currently working to initiate a [Cingal] pilot study to confirm our trial design, increase our probability of success in a Phase III trial and generate data that ultimately will be needed to support FDA approval. As a result of the COVID-19 pandemic, we no longer expect to commence the CINGAL pilot study in the first half of 2020....Our Joint Pain Management product family...include MONOVISC, ORTHOVISC, and CINGAL...HYVISC...Overall, revenue from joint pain management therapies increased 12% for the three-month period ended March 31, 2020, as compared to the same period in 2019. The increase was primarily driven by increased revenue from CINGAL and MONOVISC."

New P3 trial • Sales • Trial status • Osteoarthritis • Pain

The MONOVISC Hip Osteoarthritis Study (clinicaltrials.gov) - P3; N=220; Terminated; Sponsor: DePuy Mitek; Phase classification: P=N/A ➔ P3; Withheld ➔ Terminated; The results of the interim analysis indicate the futility criterion have been met, therefore enrollment was terminated.

Clinical • Phase classification • Trial termination