Tyrvaya (varenicline nasal spray) / Viatris - LARVOL DELTA

Varenicline Solution Nasal Spray (VNS) 0.03mg Reduces Key Inflammatory Cytokines in the Tear Film of Dry Eye Disease (ARVO 2025) - "Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Dry Eye Disease • Ocular Inflammation • Ophthalmology • IFNG • IL10 • IL17A • IL1B • IL2 • IL4 • IL6 • TNFA

Project HOPES: Healthy Options for Pain and Ending Smoking. A Program for Cancer Survivors. (clinicaltrials.gov) - P4 | N=20 | Active, not recruiting | Sponsor: Duke University | Recruiting ➔ Active, not recruiting | Trial completion date: Mar 2025 ➔ Jul 2025 | Trial primary completion date: Mar 2025 ➔ Jul 2025

Enrollment closed • Trial completion date • Trial primary completion date • Oncology • Pain • Tobacco Cessation

Drugs for dry eye disease. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Dry Eye Disease • Ophthalmology

Quintessence of currently approved and upcoming treatments for dry eye disease. (PubMed, Graefes Arch Clin Exp Ophthalmol) - "Currently, the US Food and Drug Administration (FDA)-approved medical treatments for treatment of DED include cyclosporine formulations (RESTASIS® [cyclosporine 0.05% ophthalmic emulsion], VEVYE® [cyclosporine 0.1% ophthalmic solution], and CEQUA™ [cyclosporine 0.09% ophthalmic solution]), XIIDRA® (lifitegrast), a leukocyte function-associated antigen-1 (LFA-1)/intracellular adhesion molecule-1(ICAM-1) inhibitor, EYSUVIS™ (loteprednol etabonate ophthalmic suspension 0.25%), a corticosteroid, and MIEBO™ (perfluorohexyloctane ophthalmic solution), a semifluorinated alkane. TYRVAYA™ (varenicline solution nasal spray), a cholinergic agonist, is another formulation approved for the treatment of the signs and symptoms of DED...Cyclosporine formulations TJO-087 (cyclosporine A nanoemulsion 0.08%), SCAI-001 eye drops (cyclosporine 0.01%, 0.02%) are being evaluated against RESTASIS® and other approved treatments. The potential treatments being assessed include..."

Journal • Review • Conjunctivitis • Dry Eye Disease • Ocular Infections • Ocular Inflammation • Ophthalmology • Sjogren's Syndrome • ICAM1

New Trents In Eye Care In Bahrain Most Recent Advances In Our Daily Eye Care Practice (ESCRS 2024) - "Purpose: This Abstract Explores The Integration Of New Trends In Ophthalmic Practice, Encompassing The Use Of Vuity Eye Drops, Tyrvaya Nasal Spray, Durysta, Cxl Unbound, Light Adjustable Lenses, Capsulaser, And Tepezza... Doing bilateral eye surgey whether refractive, ICL, or cataract surgery under topical anaesthesia as a day case have tremendous benefits to the patients and increased turnover of patients in eye care establishments in Bahrain."

Cataract • Ophthalmology • Strabismus

Project HOPES: Healthy Options for Pain and Ending Smoking. A Program for Cancer Survivors. (clinicaltrials.gov) - P4 | N=20 | Recruiting | Sponsor: Duke University | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Pain • Tobacco Cessation

Project HOPES: Healthy Options for Pain and Ending Smoking. A Program for Cancer Survivors. (clinicaltrials.gov) - P4 | N=20 | Not yet recruiting | Sponsor: Duke University | Initiation date: Mar 2024 ➔ Jul 2024

Trial initiation date • Oncology • Pain • Tobacco Cessation

Impact of Varenicline Solution Nasal Spray on Tear Film Cytokine Levels in Subjects with Sjogren's Disease (ARVO 2024) - P4 | "Inflammation is recognized as a contributing factor to the pathophysiology of dry eye disease (DED), and patients with Sjogren's disease often suffer from substantial DED signs and symptoms. The expression kinetics of inflammatory cytokines on the ocular surface after VNS administration have not been previously evaluated in clinical trials. The data from this trial demonstrates a reduction in ocular surface inflammatory cytokines in subjects with DED associated with moderate to severe Sjogren's disease who used VNS twice daily for 28 days."

Clinical • Dry Eye Disease • Ophthalmology • IFNG • IL10 • IL17A • IL1B • IL2 • IL4 • IL6 • TNFA

A Study Evaluating the Safety of the Nasal Pump (clinicaltrials.gov) - P4 | N=5 | Terminated | Sponsor: Oyster Point Pharma, Inc. | Active, not recruiting ➔ Terminated | N=30 ➔ 5 | Trial completion date: May 2024 ➔ Feb 2024 | Trial primary completion date: May 2024 ➔ Feb 2024; Internal strategy change. Not related to safety concerns.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Conjunctivitis • Dry Eye Disease • Ocular Infections • Ocular Inflammation • Ophthalmology

A Phase 4 Study Evaluating the Safety of the Nasal Pump (clinicaltrials.gov) - P4 | N=30 | Active, not recruiting | Sponsor: Oyster Point Pharma, Inc.

New P4 trial • Conjunctivitis • Dry Eye Disease • Ocular Infections • Ocular Inflammation • Ophthalmology

Tyrvaya: Newly added patent in Orange Book (Orange Book) - Expiry on Oct 19, 2035

Patent • Ophthalmology

Project HOPES: Healthy Options for Pain and Ending Smoking. A Program for Cancer Survivors. (clinicaltrials.gov) - P4 | N=20 | Not yet recruiting | Sponsor: Duke University | Trial completion date: Dec 2024 ➔ Mar 2025 | Initiation date: Dec 2023 ➔ Mar 2024 | Trial primary completion date: Dec 2024 ➔ Mar 2025

Trial completion date • Trial initiation date • Trial primary completion date • Oncology • Pain • Tobacco Cessation

Perfluorohexyloctane ophthalmic solution (Miebo) for dry eye disease. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Dry Eye Disease • Ophthalmology

Efficacy of bilateral OC-01 (varenicline solution) nasal spray in alleviating signs and symptoms of dry eye disease: A systematic review. (PubMed, Cont Lens Anterior Eye) - "OC-01 VNS improves dry eye symptoms and signs with a satisfactory tolerability. Therefore, OC-01 VNS seems to be a safe and effective treatment that could be recommended in patients with DED. This new treatment could be particularly useful in those patients who have difficulties with the administration of traditional topical therapies."

Journal • Review • Anesthesia • Dry Eye Disease • Ophthalmology

Project HOPES: Healthy Options for Pain and Ending Smoking. A Program for Cancer Survivors. (clinicaltrials.gov) - P4 | N=20 | Not yet recruiting | Sponsor: Duke University | Trial completion date: Sep 2024 ➔ Dec 2024 | Initiation date: Sep 2023 ➔ Dec 2023 | Trial primary completion date: Sep 2024 ➔ Dec 2024

Trial completion date • Trial initiation date • Trial primary completion date • Oncology • Pain • Tobacco Cessation

Project HOPES: Healthy Options for Pain and Ending Smoking. A Program for Cancer Survivors. (clinicaltrials.gov) - P4 | N=20 | Not yet recruiting | Sponsor: Duke University

New P4 trial • Oncology • Pain • Tobacco Cessation

Nasal Spray Study in Sjogren's Dry Eye Disease (clinicaltrials.gov) - P4 | N=39 | Completed | Sponsor: University of Pennsylvania | Recruiting ➔ Completed | Trial completion date: Feb 2025 ➔ Aug 2023 | Trial primary completion date: Feb 2024 ➔ Aug 2023

Trial completion • Trial completion date • Trial primary completion date • Dry Eye Disease • Immunology • Ophthalmology • Sjogren's Syndrome

Phase 4 Study Evaluating the Safety of the Nasal Guide With Tyrvaya (clinicaltrials.gov) - P4 | N=30 | Completed | Sponsor: Oyster Point Pharma, Inc. | Active, not recruiting ➔ Completed

Trial completion • Conjunctivitis • Dry Eye Disease • Ocular Infections • Ocular Inflammation • Ophthalmology • Sjogren's Syndrome

Phase 4 Study Evaluating the Safety of the Nasal Guide With Tyrvaya (clinicaltrials.gov) - P4 | N=30 | Active, not recruiting | Sponsor: Oyster Point Pharma, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Conjunctivitis • Dry Eye Disease • Ocular Infections • Ocular Inflammation • Ophthalmology • Sjogren's Syndrome

Phase 4 Study Evaluating the Safety of the Nasal Guide With Tyrvaya (clinicaltrials.gov) - P4 | N=30 | Recruiting | Sponsor: Oyster Point Pharma, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Conjunctivitis • Dry Eye Disease • Ocular Infections • Ocular Inflammation • Ophthalmology • Sjogren's Syndrome

Phase 4 Study Evaluating the Safety of the Nasal Guide With Tyrvaya (clinicaltrials.gov) - P4 | N=30 | Not yet recruiting | Sponsor: Oyster Point Pharma, Inc.

New P4 trial • Conjunctivitis • Dry Eye Disease • Ocular Infections • Ocular Inflammation • Ophthalmology • Sjogren's Syndrome

RANK: Investigator Initiated Study to Assess the Efficacy of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease Following Laser-assisted in Situ Keratomileusis (LASIK) (clinicaltrials.gov) - P3 | N=40 | Completed | Sponsor: Vance Thompson Vision ND | Not yet recruiting ➔ Completed | N=60 ➔ 40 | Trial completion date: Mar 2023 ➔ Aug 2022

Enrollment change • Trial completion • Trial completion date • Dry Eye Disease • Ophthalmology

Phase 2 Clinical Trial to Evaluate OC-01 Nasal Spray in Subjects With Neurotrophic Keratopathy (clinicaltrials.gov) - P2 | N=113 | Completed | Sponsor: Oyster Point Pharma, Inc. | Active, not recruiting ➔ Completed

Trial completion • Dry Eye Disease • Ophthalmology

Nasal Spray Study in Sjogren's Dry Eye Disease (clinicaltrials.gov) - P4 | N=40 | Recruiting | Sponsor: University of Pennsylvania | Not yet recruiting ➔ Recruiting

Enrollment open • Dry Eye Disease • Immunology • Ophthalmology • Sjogren's Syndrome

Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of OC-01 in Adult Chinese With Dry Eye Disease (clinicaltrials.gov) - P1 | N=9 | Completed | Sponsor: Ji Xing Pharmaceuticals (Shanghai) Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Dec 2023 ➔ Apr 2023 | Trial primary completion date: Dec 2023 ➔ Apr 2023

Trial completion • Trial completion date • Trial primary completion date • Dry Eye Disease • Ophthalmology