Varenicline Nasal Spray Improves Bilateral Tear Production in Dry Eye Disease | Latest news for doctors, nurses and pharmacists

Treatment with OC-01 nasal spray (varenicline solution) in patients with dry eye causes a substantial increase in tear production in the study eyes as well as in other eyes with milder symptoms, 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 trials. -1 and Phase III ONSET-2. One eye was designated as the study eye.

The researchers looked at the mean change from baseline in anesthetized Schirmer’s test (STS) score and the percentage of eyes achieving ≥10 mm STS improvement. They assessed these results both in the study and the other eyes as a whole and by the baseline dry eye score in the treatment groups.

In the study eyes, the mean improvement in STS 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 other unstudied eyes, the respective mean improvements in STS were 8.7 mm, 8.8 mm, and 2.7 mm.

The percentages of study eyes achieving ≥10 mm STS improvement were 48.1% in the 0.03 mg group, 48.4% in the 0.06 mg group, and 25.9% in the control group vehicle. The corresponding percentages of unstudied eyes achieving said result were 42.9%, 43.9% and 19.7%.

There were no significant interactions between treatment subgroups seen in the study or other eye STS outcomes by baseline dry eye scores. 0.05 for all).

Current data suggest that OC-01 nasal spray (varenicline solution) is effective across a broad spectrum of disease severity, and supports the recommendation of bilateral twice-daily nasal administration.

*Evaluation of the effectiveness of OC-01 Nasal Spray on the signs and symptoms of dry eye disease

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