Varenicline Nasal Spray Improves Schirmer Test Score in Dry Eye Disease

Varenicline nasal spray shows promise as a method of increasing tear production in individuals with dry eye disease (DED), according to a poster presented at the American Optometric Association 2023 ePosters Virtual Event from June 13-14 in Washington, DC. 

The presenters, which included Leslie O’Dell, OD, and Gretchen Blemker, OD, included integrated data from the ONSET-1 (ClinicalTrials.gov Identifier: NCT03636061) and ONSET-2 ( ClinicalTrials.gov Identifier: NCT04036292) trials. The team assessed changes in mean Schirmer test score among participants treated with 0.03 mg varenicline nasal spray, 0.06 mg treatment, and vehicle treatment during a 4-week study duration. Study participants underwent stratification into groups according to baseline Schirmer score (≤5 mm and >5 mm) and eye dryness score (<60 and ≥60). 

Schirmer test score increased significantly at 4 weeks among individuals treated with both doses of varenicline nasal spray compared with vehicle treatment (P <.01). Among individuals with baseline Schirmer test scores of 5 mm or less, Schirmer test score increased by 11.6 mm, 12.1 mm, and 6.1 mm in participants treated with 0.03 mg varenicline treatment, 0.06 treatment, and vehicle, respectively. These values were 11.7 mm, 11.6 mm, and 6.4 mm among individuals with a baseline Schirmer test score greater than 5 mm.

Similarly, Schirmer test score increased among both cohorts stratified according to eye dryness score. Individuals with baseline eye dryness scores less than 60 experienced Schirmer test score improvements of  12.3 mm, 13.5 mm, 6.2 mm and participants with baseline scores of 60 or greater demonstrated increases of 11.2 mm, 10.5 mm, 6.2 mm, in the 0.03 varenicline nasal spray treatment, 0.06 treatment, and vehicle groups, respectively.

Study participants did not report any drug-related serious adverse events, and the most common adverse events occurring in more than 5% of the study sample included throat irritation, nose irritation, and cough.

“With its mechanism of action and route of administration, OC-01 [varenicline nasal spray] may potentially be an effective therapeutic option for increasing natural tear production in heterogenous DED patient populations,” according to the poster presenters. 

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.