Bilateral Effect of OC-01 (Varenicline Solution) Nasal Spray for Treatment of Signs and Symptoms in Individuals with Mild, Moderate, and Severe Dry Eye Disease.

Autor: Katz J; The Midwest Center for Sight, Des Plaines, Illinois., Periman LM; Periman Eye Institute, Seattle, Washington., Maiti S; Periman Eye Institute, Seattle, Washington., Sarnicola E; Clinica degli Occhi Sarnicola, Grosseto, Italy; Ambulatorio di Chirurgia Oculare Santa Lucia, Grosseto, Italy., Hemphill M; Oyster Point Pharma Inc, Princeton, New Jersey., Kabat AG; Oyster Point Pharma Inc, Princeton, New Jersey; Salus University, Elkins Park, Pennsylvania., Hendrix LH; Oyster Point Pharma Inc, Princeton, New Jersey., Shah P; Oyster Point Pharma Inc, Princeton, New Jersey., Gibson A; Oyster Point Pharma Inc, Princeton, New Jersey. Electronic address: agibson@oysterpointrx.com.
Jazyk: angličtina
Zdroj: Clinical therapeutics [Clin Ther] 2022 Nov; Vol. 44 (11), pp. 1463-1470. Date of Electronic Publication: 2022 Oct 28.
DOI: 10.1016/j.clinthera.2022.09.013
Abstrakt: Purpose: This study compares outcomes of therapy with OC-01 (varenicline solution) for dry eye disease in study eyes and nonstudy fellow eyes of participants in 2 pivotal clinical trials.
Methods: All 891 patients randomized to receive OC-01 (varenicline solution) 0.03 mg, OC-01 (varenicline solution) 0.06 mg, or vehicle control (VC) in each nostril twice daily for 28 days in the Phase IIb ONSET-1 (Evaluation of the Efficacy of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease) and Phase III ONSET-2 trials were included in this post hoc analysis. One eye was designated as the study eye. The mean change from baseline in anesthetized Schirmer test score (STS) and the percentage of eyes achieving a ≥10-mm STS improvement were compared between treatments in study and fellow eyes overall and by baseline Eye Dryness Score.
Findings: In the study eyes, the mean STS improvement from baseline to day 28 was 10.4 mm, 10.5 mm, and 4.9 mm in the 0.03 mg, 0.06 mg, and VC groups, respectively; comparable values in nonstudy fellow eyes were 8.7 mm, 8.8 mm, and 2.7 mm, respectively. The percentages of study eyes achieving a ≥10-mm STS improvement were 48.1%, 48.4%, and 25.9%, respectively, whereas the comparable values in nonstudy eyes were 42.9%, 43.9%, and 19.7%, respectively. No significant treatment-subgroup interactions were observed in study or fellow eye STS outcomes by baseline Eye Dryness Scores <40 and ≥40 (p > 0.05 for all).
Implications: OC-01 (varenicline solution) nasal spray had significant tear film production improvements compared with VC in both study and fellow eyes. These findings suggest efficacy across a broad spectrum of presenting disease severity.
Competing Interests: Declaration of Interest The sponsor was involved in the study design, the interpretation of data, the writing of the manuscript, and the decision to submit the manuscript for publication. Laura M. Periman reports serving on the medical advisory board and speakers’ bureau for Oyster Point Pharma Inc. Sathi Maiti reports receiving clinical research funding from Oyster Point Pharma Inc. Mandy Hemphill, Alan G. Kabat, Laura H. Hendrix, Puja Shah, and Andrea Gibson are employees and shareholders of Oyster Point Pharma Inc. The authors have indicated that they have no other conflicts of interest regarding the content of this article.
(Copyright © 2022 The Author(s). Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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