The authors report the following conflicts of interest: JDS has consulted for the following companies: AbbVie, Alcon, Aldeyra, Allergan, Alphaeon, ArcScan, Avedro, Bausch & Lomb, BioLayer, Bio-Tissue, Bruder Healthcare, Clearside, Clearview, Clementia Pharma, Dompe, Eleven, Eyedetec, EyeGate Research, EyeRx Research, Eyevance, Glaukos, Hovione, Imprimis Pharma, InSite Vision Inc., Inspire/Merck Pharmaceuticals, Isis Pharmaceuticals, Johnson & Johnson/TearScience/Vistakon, Kala Pharmaceuticals, Kowa, LacriSciences, LayerBio, Lenstatin, Lumenis, Lux Biosciences, Mallinckrodt, Mati Therapeutics, MioTech, Neomedix, NicOx, NovaBay, Novaliq, Novartis, Noveome Biotherapeutics, OcuCure, Ocular Therapeutix, Oculis, Okogen, Omeros, Oyster Point, Parion, Pfizer, Portage, Quidel, Rapid Pathogen Screening, Rutech, Santen, Science Based Health, Senju, Shire, Sun Pharmaceuticals, Surrozen, Synedgen, Takeda, Talia Technology, Tear Solutions, TearLab, Topcon, TopiVert, and Xoma/Servier. on behalf of the American Academy of Optometry.Ĭonflict of Interest Disclosure: AG, corresponding author, is an employee of and shareholder in Oyster Point Pharma, Inc., the sponsor of this study. The odds of achieving a ≥10-mm improvement in STS for VNS versus VC for patients with baseline STS ≤5 and >5 were 3.4(95% confidence interval, 2.0 to 5.6) and 2.3(1.3 to 4.0) and for EDS of 5 were -7.4(95% confidence interval, -12.5 to -2.4) and -2.8(-8.7 to 3.1) EDS of <60 and ≥60 were -2.9(-8.3 to 2.5) and -8.1(-13.6 to -2.6).Ĭompared with VC, VNS improved tear production and patient-reported symptoms in patients with dry eye disease, demonstrating consistency of effect regardless of initial presenting severity.Ĭopyright © 2022 The Author(s). Efficacy was evaluated using analysis of covariance among pre-specified subgroups of mild-moderate and severe baseline disease severity defined by STS (≤5 vs. Adults 22 years or older with dry eye disease, Ocular Surface Disease Index score of ≥23, corneal fluorescein staining score of ≥2 in ≥1 regions/≥4 all regions, and Schirmer Test Score (STS) of ≤10 mm (no restrictions on Eye Dryness Score ) were included in this study. This study evaluated efficacy outcomes for VNS in patients with mild-moderate and severe dry eye disease.Īn analysis of integrated data from two randomized clinical trials, ONSET-1 ( NCT03636061) and ONSET-2 ( NCT04036292) (vehicle control, n = 294 VNS 0.03 mg, n = 308), was performed. Varenicline solution nasal spray (VNS), a unique cholinergic agonist ocular surface-sparing nasal spray therapy, demonstrated significant improvement in both signs and symptoms of dry eye disease in subjects with mild, moderate, and severe symptoms as the clinical studies enrolled a more real-world patient population. There is a clinical necessity for dry eye disease treatments that perform across a broad range of presenting patient severities.
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