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

• Published in: Clinical ophthalmology (Auckland, N.Z.) Vol. 17; pp. 725 - 734
• Main Authors: Schallhorn, Julie M, McGee, Selina, Nau, Jeffrey, Macsai, Marian, Gibson, Andrea, Blemker, Gretchen, Hendrix, Laura H, Massaro-Giordano, Mina
• Format: Journal Article
• Language: English
• Published: New Zealand Dove Medical Press Limited 01.01.2023; Taylor & Francis Ltd; Dove; Dove Medical Press
• Subjects: autoimmune disease; Autoimmune diseases; Clinical trials; Comorbidity; Comparative analysis; Confidence intervals; Diagnosis; dry eye disease; Eye diseases; eye dryness score; FDA approval; nicotinic acetylcholine receptor; Original Research; Respiratory agents; schirmer test score; Self report; tyrvaya; varenicline nasal spray; Venture capital companies; Eye Dryness Score; varenicline nasal spray; Tyrvaya; dry eye disease; autoimmune disease; Schirmer test score; nicotinic acetylcholine receptor
• ISSN: 1177-5483; 1177-5467; 1177-5483
• DOI: 10.2147/OPTH.S403953

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). 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. 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. 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.