Varenicline nasal spray improves bilateral tear production in dry eye disease

Treatment with OC-01 (varenicline solution) nasal spray in patients with dry eye results in a substantial increase in tear production in the study eyes as well as in milder presenting nonstudy fellow eyes, according to data from the ONSET-1* and ONSET-2 trials.

This post hoc analysis included 891 patients who had been randomized to receive OC-01 0.03 mg, OC-01 0.06 mg, or vehicle control in each nostril twice daily for 28 days in the phase IIb ONSET-1 and phase III ONSET-2 trials. One eye was designated as the study eye.

Researchers examined the mean change from baseline in anesthetized Schirmer test score (STS) and the percentage of eyes achieving a ≥10-mm STS improvement. They assessed these outcomes in both the study and fellow eyes overall and by baseline Eye Dryness Score across the treatment groups.

In the study eyes, the mean STS improvement from baseline to day 28 was 10.4 mm in the 0.03-mg group, 10.5 mm in the 0.06-mg group, and 4.9 mm in the vehicle control group. In the nonstudy fellow eyes, the respective the mean STS improvements were 8.7 mm, 8.8 mm, and 2.7 mm.

The percentages of study eyes achieving a ≥10-mm STS improvement were 48.1 percent in the 0.03-mg group, 48.4 percent in the 0.06-mg group, and 25.9 percent in the vehicle control group. The corresponding percentages of nonstudy eyes achieving the said outcome were 42.9 percent, 43.9 percent, and 19.7 percent.

There were no significant treatment-subgroup interactions seen in study or fellow eye STS outcomes by baseline Eye Dryness Scores <40 and ≥40 (p>0.05 for all).

The present data suggest that OC-01 (varenicline solution) nasal spray is effective across a broad spectrum of presenting disease severity, as well as support the recommendation for twice-daily bilateral nasal dosing.

*Evaluation of the Efficacy of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease