OC-01 (Varenicline Solution) Nasal Spray for the Treatment of Dry Eye Disease Signs and Symptoms in Subjects with Autoimmune Disease: Integrated Data from ONSET-1 and ONSET-2

Julie M Schallhorn,1 Selina McGee,2 Jeffrey Nau,3 Marian Macsai,3 Andrea Gibson,3 Gretchen Blemker,3 Laura H Hendrix,3 Mina Massaro-Giordano4 1Department of Ophthalmology and Francis I, Proctor Foundation, University of California, San Francisco, CA, USA; 2BeSpoke Vision, Edmond, OK, USA; 3Oyster Point Pharma, Princeton, NJ, USA; 4Scheie Eye Institute, Penn Dry Eye and Ocular Surface Center, University of Pennsylvania Health System, Philadelphia, PA, USACorrespondence: Mina Massaro-Giordano, Scheie Eye Institute, 51 N 39th Street, Philadelphia, PA, 19104, USA, Tel +1 216 662-9903, Email minapennmedicine.upenn.eduPurpose: We evaluate the treatment effect of OC-01 (varenicline solution) nasal spray (VNS) in dry eye disease (DED) subjects from two randomized trials who self-reported autoimmune disease (AID).Patients and Methods: Post hoc subgroup analysis of subjects reporting a history of AID from the integrated OC-01 VNS 0.03 or 0.06 mg and vehicle control (VC) treatment groups of the ONSET-1 and ONSET-2 trials. Mean change in Schirmer test with anesthesia score (STS, mm) and Eye Dryness Score (EDS) from baseline to 28 days was compared between OC-01 VNS and VC groups. Consistency of treatment effect in subjects with and without AID was evaluated using treatment–subgroup interaction terms in ANCOVA models for mean changes from baseline STS and EDS, and in a logistic regression model for proportion achieving ≥ 10 mm STS improvement.Results: Of the 891 participants, 31 reported comorbid AID. In all models, the treatment–subgroup interaction terms were not significant (p< 0.05), indicating consistency of therapeutic effect of OC-01 VNS in subjects with and without AID. In subjects with AID, the treatment difference for STS was 11.8 mm and − 9.3 for EDS and difference for proportion of subjects with ≥ 10 mm STS improvement was 61.1%. The most common adverse event was sneeze (82– 84%), graded as mild by 98% of subjects.Conclusion: OC-01 VNS demonstrated consistency in improving both tear production and patient-reported symptoms in subjects with AID, consistent with pivotal ONSET-1 and 2 trial results. Further investigation is warranted, and results may further support use of OC-01 VNS for DED in AID patients.Keywords: dry eye disease, autoimmune disease, Eye Dryness Score, nicotinic acetylcholine receptor, Schirmer test score, varenicline nasal spray, Tyrvaya Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Schallhorn JM [verfasserIn] McGee S [verfasserIn] Nau J [verfasserIn] Macsai M [verfasserIn] Gibson A [verfasserIn] Blemker G [verfasserIn] Hendrix LH [verfasserIn] Massaro-Giordano M [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2023

Schlagwörter:	dry eye disease autoimmune disease eye dryness score nicotinic acetylcholine receptor schirmer test score varenicline nasal spray tyrvaya

Übergeordnetes Werk:	In: Clinical Ophthalmology - Dove Medical Press, 2009, (2023), Seite 725-734
Übergeordnetes Werk:	year:2023 ; pages:725-734

Links:	Link aufrufen Link aufrufen Journal toc

Katalog-ID:	DOAJ08828008X

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520			\|a Julie M Schallhorn,1 Selina McGee,2 Jeffrey Nau,3 Marian Macsai,3 Andrea Gibson,3 Gretchen Blemker,3 Laura H Hendrix,3 Mina Massaro-Giordano4 1Department of Ophthalmology and Francis I, Proctor Foundation, University of California, San Francisco, CA, USA; 2BeSpoke Vision, Edmond, OK, USA; 3Oyster Point Pharma, Princeton, NJ, USA; 4Scheie Eye Institute, Penn Dry Eye and Ocular Surface Center, University of Pennsylvania Health System, Philadelphia, PA, USACorrespondence: Mina Massaro-Giordano, Scheie Eye Institute, 51 N 39th Street, Philadelphia, PA, 19104, USA, Tel +1 216 662-9903, Email minapennmedicine.upenn.eduPurpose: We evaluate the treatment effect of OC-01 (varenicline solution) nasal spray (VNS) in dry eye disease (DED) subjects from two randomized trials who self-reported autoimmune disease (AID).Patients and Methods: Post hoc subgroup analysis of subjects reporting a history of AID from the integrated OC-01 VNS 0.03 or 0.06 mg and vehicle control (VC) treatment groups of the ONSET-1 and ONSET-2 trials. Mean change in Schirmer test with anesthesia score (STS, mm) and Eye Dryness Score (EDS) from baseline to 28 days was compared between OC-01 VNS and VC groups. Consistency of treatment effect in subjects with and without AID was evaluated using treatment–subgroup interaction terms in ANCOVA models for mean changes from baseline STS and EDS, and in a logistic regression model for proportion achieving ≥ 10 mm STS improvement.Results: Of the 891 participants, 31 reported comorbid AID. In all models, the treatment–subgroup interaction terms were not significant (p< 0.05), indicating consistency of therapeutic effect of OC-01 VNS in subjects with and without AID. In subjects with AID, the treatment difference for STS was 11.8 mm and − 9.3 for EDS and difference for proportion of subjects with ≥ 10 mm STS improvement was 61.1%. The most common adverse event was sneeze (82– 84%), graded as mild by 98% of subjects.Conclusion: OC-01 VNS demonstrated consistency in improving both tear production and patient-reported symptoms in subjects with AID, consistent with pivotal ONSET-1 and 2 trial results. Further investigation is warranted, and results may further support use of OC-01 VNS for DED in AID patients.Keywords: dry eye disease, autoimmune disease, Eye Dryness Score, nicotinic acetylcholine receptor, Schirmer test score, varenicline nasal spray, Tyrvaya
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allfields	(DE-627)DOAJ08828008X (DE-599)DOAJ8c873e502639406b826444f9f3cff228 DE-627 ger DE-627 rakwb eng RE1-994 Schallhorn JM verfasserin aut OC-01 (Varenicline Solution) Nasal Spray for the Treatment of Dry Eye Disease Signs and Symptoms in Subjects with Autoimmune Disease: Integrated Data from ONSET-1 and ONSET-2 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Julie M Schallhorn,1 Selina McGee,2 Jeffrey Nau,3 Marian Macsai,3 Andrea Gibson,3 Gretchen Blemker,3 Laura H Hendrix,3 Mina Massaro-Giordano4 1Department of Ophthalmology and Francis I, Proctor Foundation, University of California, San Francisco, CA, USA; 2BeSpoke Vision, Edmond, OK, USA; 3Oyster Point Pharma, Princeton, NJ, USA; 4Scheie Eye Institute, Penn Dry Eye and Ocular Surface Center, University of Pennsylvania Health System, Philadelphia, PA, USACorrespondence: Mina Massaro-Giordano, Scheie Eye Institute, 51 N 39th Street, Philadelphia, PA, 19104, USA, Tel +1 216 662-9903, Email minapennmedicine.upenn.eduPurpose: We evaluate the treatment effect of OC-01 (varenicline solution) nasal spray (VNS) in dry eye disease (DED) subjects from two randomized trials who self-reported autoimmune disease (AID).Patients and Methods: Post hoc subgroup analysis of subjects reporting a history of AID from the integrated OC-01 VNS 0.03 or 0.06 mg and vehicle control (VC) treatment groups of the ONSET-1 and ONSET-2 trials. Mean change in Schirmer test with anesthesia score (STS, mm) and Eye Dryness Score (EDS) from baseline to 28 days was compared between OC-01 VNS and VC groups. Consistency of treatment effect in subjects with and without AID was evaluated using treatment–subgroup interaction terms in ANCOVA models for mean changes from baseline STS and EDS, and in a logistic regression model for proportion achieving ≥ 10 mm STS improvement.Results: Of the 891 participants, 31 reported comorbid AID. In all models, the treatment–subgroup interaction terms were not significant (p< 0.05), indicating consistency of therapeutic effect of OC-01 VNS in subjects with and without AID. In subjects with AID, the treatment difference for STS was 11.8 mm and − 9.3 for EDS and difference for proportion of subjects with ≥ 10 mm STS improvement was 61.1%. The most common adverse event was sneeze (82– 84%), graded as mild by 98% of subjects.Conclusion: OC-01 VNS demonstrated consistency in improving both tear production and patient-reported symptoms in subjects with AID, consistent with pivotal ONSET-1 and 2 trial results. Further investigation is warranted, and results may further support use of OC-01 VNS for DED in AID patients.Keywords: dry eye disease, autoimmune disease, Eye Dryness Score, nicotinic acetylcholine receptor, Schirmer test score, varenicline nasal spray, Tyrvaya dry eye disease autoimmune disease eye dryness score nicotinic acetylcholine receptor schirmer test score varenicline nasal spray tyrvaya Ophthalmology McGee S verfasserin aut Nau J verfasserin aut Macsai M verfasserin aut Gibson A verfasserin aut Blemker G verfasserin aut Hendrix LH verfasserin aut Massaro-Giordano M verfasserin aut In Clinical Ophthalmology Dove Medical Press, 2009 (2023), Seite 725-734 (DE-627)560177089 (DE-600)2415713-2 11775483 nnns year:2023 pages:725-734 https://doaj.org/article/8c873e502639406b826444f9f3cff228 kostenfrei https://www.dovepress.com/oc-01-varenicline-solution-nasal-spray-for-the-treatment-of-dry-eye-di-peer-reviewed-fulltext-article-OPTH kostenfrei https://doaj.org/toc/1177-5483 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 2023 725-734
spelling	(DE-627)DOAJ08828008X (DE-599)DOAJ8c873e502639406b826444f9f3cff228 DE-627 ger DE-627 rakwb eng RE1-994 Schallhorn JM verfasserin aut OC-01 (Varenicline Solution) Nasal Spray for the Treatment of Dry Eye Disease Signs and Symptoms in Subjects with Autoimmune Disease: Integrated Data from ONSET-1 and ONSET-2 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Julie M Schallhorn,1 Selina McGee,2 Jeffrey Nau,3 Marian Macsai,3 Andrea Gibson,3 Gretchen Blemker,3 Laura H Hendrix,3 Mina Massaro-Giordano4 1Department of Ophthalmology and Francis I, Proctor Foundation, University of California, San Francisco, CA, USA; 2BeSpoke Vision, Edmond, OK, USA; 3Oyster Point Pharma, Princeton, NJ, USA; 4Scheie Eye Institute, Penn Dry Eye and Ocular Surface Center, University of Pennsylvania Health System, Philadelphia, PA, USACorrespondence: Mina Massaro-Giordano, Scheie Eye Institute, 51 N 39th Street, Philadelphia, PA, 19104, USA, Tel +1 216 662-9903, Email minapennmedicine.upenn.eduPurpose: We evaluate the treatment effect of OC-01 (varenicline solution) nasal spray (VNS) in dry eye disease (DED) subjects from two randomized trials who self-reported autoimmune disease (AID).Patients and Methods: Post hoc subgroup analysis of subjects reporting a history of AID from the integrated OC-01 VNS 0.03 or 0.06 mg and vehicle control (VC) treatment groups of the ONSET-1 and ONSET-2 trials. Mean change in Schirmer test with anesthesia score (STS, mm) and Eye Dryness Score (EDS) from baseline to 28 days was compared between OC-01 VNS and VC groups. Consistency of treatment effect in subjects with and without AID was evaluated using treatment–subgroup interaction terms in ANCOVA models for mean changes from baseline STS and EDS, and in a logistic regression model for proportion achieving ≥ 10 mm STS improvement.Results: Of the 891 participants, 31 reported comorbid AID. In all models, the treatment–subgroup interaction terms were not significant (p< 0.05), indicating consistency of therapeutic effect of OC-01 VNS in subjects with and without AID. In subjects with AID, the treatment difference for STS was 11.8 mm and − 9.3 for EDS and difference for proportion of subjects with ≥ 10 mm STS improvement was 61.1%. The most common adverse event was sneeze (82– 84%), graded as mild by 98% of subjects.Conclusion: OC-01 VNS demonstrated consistency in improving both tear production and patient-reported symptoms in subjects with AID, consistent with pivotal ONSET-1 and 2 trial results. Further investigation is warranted, and results may further support use of OC-01 VNS for DED in AID patients.Keywords: dry eye disease, autoimmune disease, Eye Dryness Score, nicotinic acetylcholine receptor, Schirmer test score, varenicline nasal spray, Tyrvaya dry eye disease autoimmune disease eye dryness score nicotinic acetylcholine receptor schirmer test score varenicline nasal spray tyrvaya Ophthalmology McGee S verfasserin aut Nau J verfasserin aut Macsai M verfasserin aut Gibson A verfasserin aut Blemker G verfasserin aut Hendrix LH verfasserin aut Massaro-Giordano M verfasserin aut In Clinical Ophthalmology Dove Medical Press, 2009 (2023), Seite 725-734 (DE-627)560177089 (DE-600)2415713-2 11775483 nnns year:2023 pages:725-734 https://doaj.org/article/8c873e502639406b826444f9f3cff228 kostenfrei https://www.dovepress.com/oc-01-varenicline-solution-nasal-spray-for-the-treatment-of-dry-eye-di-peer-reviewed-fulltext-article-OPTH kostenfrei https://doaj.org/toc/1177-5483 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 2023 725-734
allfields_unstemmed	(DE-627)DOAJ08828008X (DE-599)DOAJ8c873e502639406b826444f9f3cff228 DE-627 ger DE-627 rakwb eng RE1-994 Schallhorn JM verfasserin aut OC-01 (Varenicline Solution) Nasal Spray for the Treatment of Dry Eye Disease Signs and Symptoms in Subjects with Autoimmune Disease: Integrated Data from ONSET-1 and ONSET-2 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Julie M Schallhorn,1 Selina McGee,2 Jeffrey Nau,3 Marian Macsai,3 Andrea Gibson,3 Gretchen Blemker,3 Laura H Hendrix,3 Mina Massaro-Giordano4 1Department of Ophthalmology and Francis I, Proctor Foundation, University of California, San Francisco, CA, USA; 2BeSpoke Vision, Edmond, OK, USA; 3Oyster Point Pharma, Princeton, NJ, USA; 4Scheie Eye Institute, Penn Dry Eye and Ocular Surface Center, University of Pennsylvania Health System, Philadelphia, PA, USACorrespondence: Mina Massaro-Giordano, Scheie Eye Institute, 51 N 39th Street, Philadelphia, PA, 19104, USA, Tel +1 216 662-9903, Email minapennmedicine.upenn.eduPurpose: We evaluate the treatment effect of OC-01 (varenicline solution) nasal spray (VNS) in dry eye disease (DED) subjects from two randomized trials who self-reported autoimmune disease (AID).Patients and Methods: Post hoc subgroup analysis of subjects reporting a history of AID from the integrated OC-01 VNS 0.03 or 0.06 mg and vehicle control (VC) treatment groups of the ONSET-1 and ONSET-2 trials. Mean change in Schirmer test with anesthesia score (STS, mm) and Eye Dryness Score (EDS) from baseline to 28 days was compared between OC-01 VNS and VC groups. Consistency of treatment effect in subjects with and without AID was evaluated using treatment–subgroup interaction terms in ANCOVA models for mean changes from baseline STS and EDS, and in a logistic regression model for proportion achieving ≥ 10 mm STS improvement.Results: Of the 891 participants, 31 reported comorbid AID. In all models, the treatment–subgroup interaction terms were not significant (p< 0.05), indicating consistency of therapeutic effect of OC-01 VNS in subjects with and without AID. In subjects with AID, the treatment difference for STS was 11.8 mm and − 9.3 for EDS and difference for proportion of subjects with ≥ 10 mm STS improvement was 61.1%. The most common adverse event was sneeze (82– 84%), graded as mild by 98% of subjects.Conclusion: OC-01 VNS demonstrated consistency in improving both tear production and patient-reported symptoms in subjects with AID, consistent with pivotal ONSET-1 and 2 trial results. Further investigation is warranted, and results may further support use of OC-01 VNS for DED in AID patients.Keywords: dry eye disease, autoimmune disease, Eye Dryness Score, nicotinic acetylcholine receptor, Schirmer test score, varenicline nasal spray, Tyrvaya dry eye disease autoimmune disease eye dryness score nicotinic acetylcholine receptor schirmer test score varenicline nasal spray tyrvaya Ophthalmology McGee S verfasserin aut Nau J verfasserin aut Macsai M verfasserin aut Gibson A verfasserin aut Blemker G verfasserin aut Hendrix LH verfasserin aut Massaro-Giordano M verfasserin aut In Clinical Ophthalmology Dove Medical Press, 2009 (2023), Seite 725-734 (DE-627)560177089 (DE-600)2415713-2 11775483 nnns year:2023 pages:725-734 https://doaj.org/article/8c873e502639406b826444f9f3cff228 kostenfrei https://www.dovepress.com/oc-01-varenicline-solution-nasal-spray-for-the-treatment-of-dry-eye-di-peer-reviewed-fulltext-article-OPTH kostenfrei https://doaj.org/toc/1177-5483 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 2023 725-734
allfieldsGer	(DE-627)DOAJ08828008X (DE-599)DOAJ8c873e502639406b826444f9f3cff228 DE-627 ger DE-627 rakwb eng RE1-994 Schallhorn JM verfasserin aut OC-01 (Varenicline Solution) Nasal Spray for the Treatment of Dry Eye Disease Signs and Symptoms in Subjects with Autoimmune Disease: Integrated Data from ONSET-1 and ONSET-2 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Julie M Schallhorn,1 Selina McGee,2 Jeffrey Nau,3 Marian Macsai,3 Andrea Gibson,3 Gretchen Blemker,3 Laura H Hendrix,3 Mina Massaro-Giordano4 1Department of Ophthalmology and Francis I, Proctor Foundation, University of California, San Francisco, CA, USA; 2BeSpoke Vision, Edmond, OK, USA; 3Oyster Point Pharma, Princeton, NJ, USA; 4Scheie Eye Institute, Penn Dry Eye and Ocular Surface Center, University of Pennsylvania Health System, Philadelphia, PA, USACorrespondence: Mina Massaro-Giordano, Scheie Eye Institute, 51 N 39th Street, Philadelphia, PA, 19104, USA, Tel +1 216 662-9903, Email minapennmedicine.upenn.eduPurpose: We evaluate the treatment effect of OC-01 (varenicline solution) nasal spray (VNS) in dry eye disease (DED) subjects from two randomized trials who self-reported autoimmune disease (AID).Patients and Methods: Post hoc subgroup analysis of subjects reporting a history of AID from the integrated OC-01 VNS 0.03 or 0.06 mg and vehicle control (VC) treatment groups of the ONSET-1 and ONSET-2 trials. Mean change in Schirmer test with anesthesia score (STS, mm) and Eye Dryness Score (EDS) from baseline to 28 days was compared between OC-01 VNS and VC groups. Consistency of treatment effect in subjects with and without AID was evaluated using treatment–subgroup interaction terms in ANCOVA models for mean changes from baseline STS and EDS, and in a logistic regression model for proportion achieving ≥ 10 mm STS improvement.Results: Of the 891 participants, 31 reported comorbid AID. In all models, the treatment–subgroup interaction terms were not significant (p< 0.05), indicating consistency of therapeutic effect of OC-01 VNS in subjects with and without AID. In subjects with AID, the treatment difference for STS was 11.8 mm and − 9.3 for EDS and difference for proportion of subjects with ≥ 10 mm STS improvement was 61.1%. The most common adverse event was sneeze (82– 84%), graded as mild by 98% of subjects.Conclusion: OC-01 VNS demonstrated consistency in improving both tear production and patient-reported symptoms in subjects with AID, consistent with pivotal ONSET-1 and 2 trial results. Further investigation is warranted, and results may further support use of OC-01 VNS for DED in AID patients.Keywords: dry eye disease, autoimmune disease, Eye Dryness Score, nicotinic acetylcholine receptor, Schirmer test score, varenicline nasal spray, Tyrvaya dry eye disease autoimmune disease eye dryness score nicotinic acetylcholine receptor schirmer test score varenicline nasal spray tyrvaya Ophthalmology McGee S verfasserin aut Nau J verfasserin aut Macsai M verfasserin aut Gibson A verfasserin aut Blemker G verfasserin aut Hendrix LH verfasserin aut Massaro-Giordano M verfasserin aut In Clinical Ophthalmology Dove Medical Press, 2009 (2023), Seite 725-734 (DE-627)560177089 (DE-600)2415713-2 11775483 nnns year:2023 pages:725-734 https://doaj.org/article/8c873e502639406b826444f9f3cff228 kostenfrei https://www.dovepress.com/oc-01-varenicline-solution-nasal-spray-for-the-treatment-of-dry-eye-di-peer-reviewed-fulltext-article-OPTH kostenfrei https://doaj.org/toc/1177-5483 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 2023 725-734
allfieldsSound	(DE-627)DOAJ08828008X (DE-599)DOAJ8c873e502639406b826444f9f3cff228 DE-627 ger DE-627 rakwb eng RE1-994 Schallhorn JM verfasserin aut OC-01 (Varenicline Solution) Nasal Spray for the Treatment of Dry Eye Disease Signs and Symptoms in Subjects with Autoimmune Disease: Integrated Data from ONSET-1 and ONSET-2 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Julie M Schallhorn,1 Selina McGee,2 Jeffrey Nau,3 Marian Macsai,3 Andrea Gibson,3 Gretchen Blemker,3 Laura H Hendrix,3 Mina Massaro-Giordano4 1Department of Ophthalmology and Francis I, Proctor Foundation, University of California, San Francisco, CA, USA; 2BeSpoke Vision, Edmond, OK, USA; 3Oyster Point Pharma, Princeton, NJ, USA; 4Scheie Eye Institute, Penn Dry Eye and Ocular Surface Center, University of Pennsylvania Health System, Philadelphia, PA, USACorrespondence: Mina Massaro-Giordano, Scheie Eye Institute, 51 N 39th Street, Philadelphia, PA, 19104, USA, Tel +1 216 662-9903, Email minapennmedicine.upenn.eduPurpose: We evaluate the treatment effect of OC-01 (varenicline solution) nasal spray (VNS) in dry eye disease (DED) subjects from two randomized trials who self-reported autoimmune disease (AID).Patients and Methods: Post hoc subgroup analysis of subjects reporting a history of AID from the integrated OC-01 VNS 0.03 or 0.06 mg and vehicle control (VC) treatment groups of the ONSET-1 and ONSET-2 trials. Mean change in Schirmer test with anesthesia score (STS, mm) and Eye Dryness Score (EDS) from baseline to 28 days was compared between OC-01 VNS and VC groups. Consistency of treatment effect in subjects with and without AID was evaluated using treatment–subgroup interaction terms in ANCOVA models for mean changes from baseline STS and EDS, and in a logistic regression model for proportion achieving ≥ 10 mm STS improvement.Results: Of the 891 participants, 31 reported comorbid AID. In all models, the treatment–subgroup interaction terms were not significant (p< 0.05), indicating consistency of therapeutic effect of OC-01 VNS in subjects with and without AID. In subjects with AID, the treatment difference for STS was 11.8 mm and − 9.3 for EDS and difference for proportion of subjects with ≥ 10 mm STS improvement was 61.1%. The most common adverse event was sneeze (82– 84%), graded as mild by 98% of subjects.Conclusion: OC-01 VNS demonstrated consistency in improving both tear production and patient-reported symptoms in subjects with AID, consistent with pivotal ONSET-1 and 2 trial results. Further investigation is warranted, and results may further support use of OC-01 VNS for DED in AID patients.Keywords: dry eye disease, autoimmune disease, Eye Dryness Score, nicotinic acetylcholine receptor, Schirmer test score, varenicline nasal spray, Tyrvaya dry eye disease autoimmune disease eye dryness score nicotinic acetylcholine receptor schirmer test score varenicline nasal spray tyrvaya Ophthalmology McGee S verfasserin aut Nau J verfasserin aut Macsai M verfasserin aut Gibson A verfasserin aut Blemker G verfasserin aut Hendrix LH verfasserin aut Massaro-Giordano M verfasserin aut In Clinical Ophthalmology Dove Medical Press, 2009 (2023), Seite 725-734 (DE-627)560177089 (DE-600)2415713-2 11775483 nnns year:2023 pages:725-734 https://doaj.org/article/8c873e502639406b826444f9f3cff228 kostenfrei https://www.dovepress.com/oc-01-varenicline-solution-nasal-spray-for-the-treatment-of-dry-eye-di-peer-reviewed-fulltext-article-OPTH kostenfrei https://doaj.org/toc/1177-5483 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 2023 725-734
language	English
source	In Clinical Ophthalmology (2023), Seite 725-734 year:2023 pages:725-734
sourceStr	In Clinical Ophthalmology (2023), Seite 725-734 year:2023 pages:725-734
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	dry eye disease autoimmune disease eye dryness score nicotinic acetylcholine receptor schirmer test score varenicline nasal spray tyrvaya Ophthalmology
isfreeaccess_bool	true
container_title	Clinical Ophthalmology
authorswithroles_txt_mv	Schallhorn JM @@aut@@ McGee S @@aut@@ Nau J @@aut@@ Macsai M @@aut@@ Gibson A @@aut@@ Blemker G @@aut@@ Hendrix LH @@aut@@ Massaro-Giordano M @@aut@@
publishDateDaySort_date	2023-01-01T00:00:00Z
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language_de	englisch
fullrecord	<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000naa a22002652 4500</leader><controlfield tag="001">DOAJ08828008X</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230410111156.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">230410s2023 xx \|\|\|\|\|o 00\| \|\|eng c</controlfield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)DOAJ08828008X</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-599)DOAJ8c873e502639406b826444f9f3cff228</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="050" ind1=" " ind2="0"><subfield code="a">RE1-994</subfield></datafield><datafield tag="100" ind1="0" ind2=" "><subfield code="a">Schallhorn JM</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">OC-01 (Varenicline Solution) Nasal Spray for the Treatment of Dry Eye Disease Signs and Symptoms in Subjects with Autoimmune Disease: Integrated Data from ONSET-1 and ONSET-2</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2023</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">Julie M Schallhorn,1 Selina McGee,2 Jeffrey Nau,3 Marian Macsai,3 Andrea Gibson,3 Gretchen Blemker,3 Laura H Hendrix,3 Mina Massaro-Giordano4 1Department of Ophthalmology and Francis I, Proctor Foundation, University of California, San Francisco, CA, USA; 2BeSpoke Vision, Edmond, OK, USA; 3Oyster Point Pharma, Princeton, NJ, USA; 4Scheie Eye Institute, Penn Dry Eye and Ocular Surface Center, University of Pennsylvania Health System, Philadelphia, PA, USACorrespondence: Mina Massaro-Giordano, Scheie Eye Institute, 51 N 39th Street, Philadelphia, PA, 19104, USA, Tel +1 216 662-9903, Email minapennmedicine.upenn.eduPurpose: We evaluate the treatment effect of OC-01 (varenicline solution) nasal spray (VNS) in dry eye disease (DED) subjects from two randomized trials who self-reported autoimmune disease (AID).Patients and Methods: Post hoc subgroup analysis of subjects reporting a history of AID from the integrated OC-01 VNS 0.03 or 0.06 mg and vehicle control (VC) treatment groups of the ONSET-1 and ONSET-2 trials. Mean change in Schirmer test with anesthesia score (STS, mm) and Eye Dryness Score (EDS) from baseline to 28 days was compared between OC-01 VNS and VC groups. Consistency of treatment effect in subjects with and without AID was evaluated using treatment–subgroup interaction terms in ANCOVA models for mean changes from baseline STS and EDS, and in a logistic regression model for proportion achieving ≥ 10 mm STS improvement.Results: Of the 891 participants, 31 reported comorbid AID. In all models, the treatment–subgroup interaction terms were not significant (p< 0.05), indicating consistency of therapeutic effect of OC-01 VNS in subjects with and without AID. In subjects with AID, the treatment difference for STS was 11.8 mm and − 9.3 for EDS and difference for proportion of subjects with ≥ 10 mm STS improvement was 61.1%. The most common adverse event was sneeze (82– 84%), graded as mild by 98% of subjects.Conclusion: OC-01 VNS demonstrated consistency in improving both tear production and patient-reported symptoms in subjects with AID, consistent with pivotal ONSET-1 and 2 trial results. 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callnumber-first	R - Medicine
author	Schallhorn JM
spellingShingle	Schallhorn JM misc RE1-994 misc dry eye disease misc autoimmune disease misc eye dryness score misc nicotinic acetylcholine receptor misc schirmer test score misc varenicline nasal spray misc tyrvaya misc Ophthalmology OC-01 (Varenicline Solution) Nasal Spray for the Treatment of Dry Eye Disease Signs and Symptoms in Subjects with Autoimmune Disease: Integrated Data from ONSET-1 and ONSET-2
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topic_title	RE1-994 OC-01 (Varenicline Solution) Nasal Spray for the Treatment of Dry Eye Disease Signs and Symptoms in Subjects with Autoimmune Disease: Integrated Data from ONSET-1 and ONSET-2 dry eye disease autoimmune disease eye dryness score nicotinic acetylcholine receptor schirmer test score varenicline nasal spray tyrvaya
topic	misc RE1-994 misc dry eye disease misc autoimmune disease misc eye dryness score misc nicotinic acetylcholine receptor misc schirmer test score misc varenicline nasal spray misc tyrvaya misc Ophthalmology
topic_unstemmed	misc RE1-994 misc dry eye disease misc autoimmune disease misc eye dryness score misc nicotinic acetylcholine receptor misc schirmer test score misc varenicline nasal spray misc tyrvaya misc Ophthalmology
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title	OC-01 (Varenicline Solution) Nasal Spray for the Treatment of Dry Eye Disease Signs and Symptoms in Subjects with Autoimmune Disease: Integrated Data from ONSET-1 and ONSET-2
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title_full	OC-01 (Varenicline Solution) Nasal Spray for the Treatment of Dry Eye Disease Signs and Symptoms in Subjects with Autoimmune Disease: Integrated Data from ONSET-1 and ONSET-2
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author_browse	Schallhorn JM McGee S Nau J Macsai M Gibson A Blemker G Hendrix LH Massaro-Giordano M
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title_sort	oc-01 (varenicline solution) nasal spray for the treatment of dry eye disease signs and symptoms in subjects with autoimmune disease: integrated data from onset-1 and onset-2
callnumber	RE1-994
title_auth	OC-01 (Varenicline Solution) Nasal Spray for the Treatment of Dry Eye Disease Signs and Symptoms in Subjects with Autoimmune Disease: Integrated Data from ONSET-1 and ONSET-2
abstract	Julie M Schallhorn,1 Selina McGee,2 Jeffrey Nau,3 Marian Macsai,3 Andrea Gibson,3 Gretchen Blemker,3 Laura H Hendrix,3 Mina Massaro-Giordano4 1Department of Ophthalmology and Francis I, Proctor Foundation, University of California, San Francisco, CA, USA; 2BeSpoke Vision, Edmond, OK, USA; 3Oyster Point Pharma, Princeton, NJ, USA; 4Scheie Eye Institute, Penn Dry Eye and Ocular Surface Center, University of Pennsylvania Health System, Philadelphia, PA, USACorrespondence: Mina Massaro-Giordano, Scheie Eye Institute, 51 N 39th Street, Philadelphia, PA, 19104, USA, Tel +1 216 662-9903, Email minapennmedicine.upenn.eduPurpose: We evaluate the treatment effect of OC-01 (varenicline solution) nasal spray (VNS) in dry eye disease (DED) subjects from two randomized trials who self-reported autoimmune disease (AID).Patients and Methods: Post hoc subgroup analysis of subjects reporting a history of AID from the integrated OC-01 VNS 0.03 or 0.06 mg and vehicle control (VC) treatment groups of the ONSET-1 and ONSET-2 trials. Mean change in Schirmer test with anesthesia score (STS, mm) and Eye Dryness Score (EDS) from baseline to 28 days was compared between OC-01 VNS and VC groups. Consistency of treatment effect in subjects with and without AID was evaluated using treatment–subgroup interaction terms in ANCOVA models for mean changes from baseline STS and EDS, and in a logistic regression model for proportion achieving ≥ 10 mm STS improvement.Results: Of the 891 participants, 31 reported comorbid AID. In all models, the treatment–subgroup interaction terms were not significant (p< 0.05), indicating consistency of therapeutic effect of OC-01 VNS in subjects with and without AID. In subjects with AID, the treatment difference for STS was 11.8 mm and − 9.3 for EDS and difference for proportion of subjects with ≥ 10 mm STS improvement was 61.1%. The most common adverse event was sneeze (82– 84%), graded as mild by 98% of subjects.Conclusion: OC-01 VNS demonstrated consistency in improving both tear production and patient-reported symptoms in subjects with AID, consistent with pivotal ONSET-1 and 2 trial results. Further investigation is warranted, and results may further support use of OC-01 VNS for DED in AID patients.Keywords: dry eye disease, autoimmune disease, Eye Dryness Score, nicotinic acetylcholine receptor, Schirmer test score, varenicline nasal spray, Tyrvaya
abstractGer	Julie M Schallhorn,1 Selina McGee,2 Jeffrey Nau,3 Marian Macsai,3 Andrea Gibson,3 Gretchen Blemker,3 Laura H Hendrix,3 Mina Massaro-Giordano4 1Department of Ophthalmology and Francis I, Proctor Foundation, University of California, San Francisco, CA, USA; 2BeSpoke Vision, Edmond, OK, USA; 3Oyster Point Pharma, Princeton, NJ, USA; 4Scheie Eye Institute, Penn Dry Eye and Ocular Surface Center, University of Pennsylvania Health System, Philadelphia, PA, USACorrespondence: Mina Massaro-Giordano, Scheie Eye Institute, 51 N 39th Street, Philadelphia, PA, 19104, USA, Tel +1 216 662-9903, Email minapennmedicine.upenn.eduPurpose: We evaluate the treatment effect of OC-01 (varenicline solution) nasal spray (VNS) in dry eye disease (DED) subjects from two randomized trials who self-reported autoimmune disease (AID).Patients and Methods: Post hoc subgroup analysis of subjects reporting a history of AID from the integrated OC-01 VNS 0.03 or 0.06 mg and vehicle control (VC) treatment groups of the ONSET-1 and ONSET-2 trials. Mean change in Schirmer test with anesthesia score (STS, mm) and Eye Dryness Score (EDS) from baseline to 28 days was compared between OC-01 VNS and VC groups. Consistency of treatment effect in subjects with and without AID was evaluated using treatment–subgroup interaction terms in ANCOVA models for mean changes from baseline STS and EDS, and in a logistic regression model for proportion achieving ≥ 10 mm STS improvement.Results: Of the 891 participants, 31 reported comorbid AID. In all models, the treatment–subgroup interaction terms were not significant (p< 0.05), indicating consistency of therapeutic effect of OC-01 VNS in subjects with and without AID. In subjects with AID, the treatment difference for STS was 11.8 mm and − 9.3 for EDS and difference for proportion of subjects with ≥ 10 mm STS improvement was 61.1%. The most common adverse event was sneeze (82– 84%), graded as mild by 98% of subjects.Conclusion: OC-01 VNS demonstrated consistency in improving both tear production and patient-reported symptoms in subjects with AID, consistent with pivotal ONSET-1 and 2 trial results. Further investigation is warranted, and results may further support use of OC-01 VNS for DED in AID patients.Keywords: dry eye disease, autoimmune disease, Eye Dryness Score, nicotinic acetylcholine receptor, Schirmer test score, varenicline nasal spray, Tyrvaya
abstract_unstemmed	Julie M Schallhorn,1 Selina McGee,2 Jeffrey Nau,3 Marian Macsai,3 Andrea Gibson,3 Gretchen Blemker,3 Laura H Hendrix,3 Mina Massaro-Giordano4 1Department of Ophthalmology and Francis I, Proctor Foundation, University of California, San Francisco, CA, USA; 2BeSpoke Vision, Edmond, OK, USA; 3Oyster Point Pharma, Princeton, NJ, USA; 4Scheie Eye Institute, Penn Dry Eye and Ocular Surface Center, University of Pennsylvania Health System, Philadelphia, PA, USACorrespondence: Mina Massaro-Giordano, Scheie Eye Institute, 51 N 39th Street, Philadelphia, PA, 19104, USA, Tel +1 216 662-9903, Email minapennmedicine.upenn.eduPurpose: We evaluate the treatment effect of OC-01 (varenicline solution) nasal spray (VNS) in dry eye disease (DED) subjects from two randomized trials who self-reported autoimmune disease (AID).Patients and Methods: Post hoc subgroup analysis of subjects reporting a history of AID from the integrated OC-01 VNS 0.03 or 0.06 mg and vehicle control (VC) treatment groups of the ONSET-1 and ONSET-2 trials. Mean change in Schirmer test with anesthesia score (STS, mm) and Eye Dryness Score (EDS) from baseline to 28 days was compared between OC-01 VNS and VC groups. Consistency of treatment effect in subjects with and without AID was evaluated using treatment–subgroup interaction terms in ANCOVA models for mean changes from baseline STS and EDS, and in a logistic regression model for proportion achieving ≥ 10 mm STS improvement.Results: Of the 891 participants, 31 reported comorbid AID. In all models, the treatment–subgroup interaction terms were not significant (p< 0.05), indicating consistency of therapeutic effect of OC-01 VNS in subjects with and without AID. In subjects with AID, the treatment difference for STS was 11.8 mm and − 9.3 for EDS and difference for proportion of subjects with ≥ 10 mm STS improvement was 61.1%. The most common adverse event was sneeze (82– 84%), graded as mild by 98% of subjects.Conclusion: OC-01 VNS demonstrated consistency in improving both tear production and patient-reported symptoms in subjects with AID, consistent with pivotal ONSET-1 and 2 trial results. Further investigation is warranted, and results may further support use of OC-01 VNS for DED in AID patients.Keywords: dry eye disease, autoimmune disease, Eye Dryness Score, nicotinic acetylcholine receptor, Schirmer test score, varenicline nasal spray, Tyrvaya
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title_short	OC-01 (Varenicline Solution) Nasal Spray for the Treatment of Dry Eye Disease Signs and Symptoms in Subjects with Autoimmune Disease: Integrated Data from ONSET-1 and ONSET-2
url	https://doaj.org/article/8c873e502639406b826444f9f3cff228 https://www.dovepress.com/oc-01-varenicline-solution-nasal-spray-for-the-treatment-of-dry-eye-di-peer-reviewed-fulltext-article-OPTH https://doaj.org/toc/1177-5483
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OC-01 (Varenicline Solution) Nasal Spray for the Treatment of Dry Eye Disease Signs and Symptoms in Subjects with Autoimmune Disease: Integrated Data from ONSET-1 and ONSET-2

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