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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 mina@pennmedicine.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

Alice T Epitropoulos,1,2 Sheraz M Daya,3 Cynthia Matossian,4 Alan G Kabat,5,6 Gretchen Blemker,5 Kristen Striffler,5 Laura Hendrix,5 Marian Macsai,5 Andrea Gibson5 1Ophthalmic Surgeons & Consultants of Ohio, the Eye Center of Columbus, Columbus, OH, USA; 2Department of Ophthalmology, the Ohio State University Wexner Medical Center, Columbus, OH, USA; 3Centre for Sight, London, UK; 4Matossian Eye Associates, Pennington, NJ, USA; 5Oyster Point Pharma, Inc, Princeton, NJ, USA; 6Salus University, Elkins Park, PA, USACorrespondence: Andrea Gibson, Oyster Point Pharma, Inc, 202 Carnegie Center, Suite 109, Princeton, NJ, 08540, USA, Tel +1-860-227-1034, Fax +1-856-433-8439, Email agibson@oysterpointrx.comPurpose: To evaluate OC-01 [varenicline solution nasal spray (VNS)] tear production and symptom outcomes in patients with dry eye disease by age, gender, race, ethnicity, and artificial tear use status.Patients and Methods: Adults ≥ 22 years of age diagnosed with dry eye disease, with Ocular Surface Disease Index score ≥ 23, corneal fluorescein staining score ≥ 2 in ≥ 1 region or ≥ 4 for all regions, and baseline Schirmer Test Score (STS) ≤ 10 mm, with no restrictions on eye dryness score (EDS). Efficacy was assessed using integrated data from ONSET-1 and ONSET-2 [vehicle control (VC), n=294; OC-01 VNS 0.03 mg, n=308]. Subgroups included age (≤ 55, 56− 65, > 65 years), gender (male, female), race (White, Black or African American), ethnicity (Hispanic or Latino, Not Hispanic or Latino), and artificial tear use (yes, no). Analysis of covariance models, with the covariates treatment, study site, and baseline severity measures, were used to calculate treatment−VC differences. Consistency of effect among subgroups was evaluated by conducting interaction tests.Results: Consistency of treatment effect across subgroups was observed for all endpoints, with P value for all treatment−subgroup interaction terms > 0.05. For % of patients with ≥ 10mm improvement in STS and least squares (LS) mean change from baseline in STS and EDS, there was improvement in tear production across demographic group categories. Artificial tear use did not change STS or EDS outcomes with OC-01 VNS.Conclusion: OC-01 VNS improved tear production and patient-reported symptom outcomes across a broad range of patients by age, gender, race, and ethnicity, and regardless of artificial tear use status at baseline. OC-01 VNS demonstrated a consistent benefit across an extensive range of patients with dry eye disease.Keywords: bioactivation, dry eye disease, nicotinic acetylcholine receptor, tear production, varenicline nasal spray