Varenicline Nasal Spray Improves Tear Production, Dry Eye Disease Symptoms

Varenicline nasal spray (VNS) may improve both tear production and symptoms in patients with varying dry eye disease (DED) severity, according to a study published in Optometry and Vision Science.

Researchers performed an integrative analysis of the ONSET-1 (ClinicalTrials.gov Identifier: NCT03636061) and ONSET-2 (ClinicalTrials.gov Identifier: NCT04036292) clinical trials — both 4-week, multicenter, randomized, vehicle-controlled trials designed to evaluate tear production and sign and symptom improvements in patients with DED following VNS treatment. The team included 602 individuals with clinically diagnosed DED (mean age, 60.7 years; 74% women) assigned to treatment with either VNS 0.03 mg (n=308) or a vehicle control (n=294). Efficacy endpoints included the percentage of patients achieving a 10 mm or greater improvement in Schirmer score and mean changes in both Schirmer test and Eye Dryness Score during the 4-week study duration. 

Individuals treated with VNS demonstrated improved tear film production and DED symptoms compared with control group participants, according to the report. A total of 48.1% of participants treated with VNS met the efficacy endpoint of a 10 mm or greater Schirmer score improvement compared with 25.9% of individuals treated with the vehicle (P <.001). The least-squares mean changes from baseline for both Schirmer test and Eye Dryness Score were greater among participants treated with VNS compared with participants receiving vehicle treatment (10.4 vs 4.9 mm; P <.001 and -14.7 vs -9.0; P =.003, respectively).

Stratified according to DED severity, the odds ratio (OR) for achieving a 10 mm or greater Schirmer score improvement in VNS vs vehicle use was 3.4 (95% CI, 2.0–5.6) in individuals with a baseline Schirmer score of 5 or less compared with an OR of 2.3 (95% CI, 1.3–4.0) for individuals with a baseline score greater than 5 mm. The ORs for Eye Dryness Scores less than 60 and 60 or greater were 3.4(95% CI, 1.9–6.1) and 2.5(95% CI, 1.5–4.0) for attaining a 10 mm Schirmer score improvement.   

“These data demonstrate the potential for varenicline solution nasal spray to be beneficial for a broad range of presenting patient disease severities,” according to the researchers. “Our data may further inform clinicians’ decision-making regarding initiating pharmacologic neuro-activation of natural tear production improvements earlier in the treatment course and in managing the complexity of treatment approach considerations for this challenging disorder.” 

A post hoc analysis and limitations in primary study designs are acknowledged limitations to the research.

Disclosure: This research was supported by Oyster Point Pharma, Inc. Please see the original reference for a full list of disclosures.