A nicotinic acetylcholine receptor agonist nasal spray used twice daily significantly improved the signs and symptoms of dry eye disease, according to a study.
The nasal spray, OC-01 (varenicline solution), was found to be well tolerated amongst trial participants.
In this phase 2b, multicenter, randomized, double-masked, vehicle-controlled trial, 182 patients with dry eye disease and previous use of artificial tears were randomized 1:1:1:1 to control (vehicle nasal spray twice daily [BID]), OC-01 0.006 mg BID, OC-01 0.03 mg BID, and OC-01 0.06 mg BID.
At day 28, patients who received 0.03 mg or 0.06 mg of OC-01 demonstrated a statistically significant improvement in tear film production compared to vehicle with least squares mean differences from vehicle of 7.7 mm with OC-01 0.03 mg and 7.5 mm with OC-01 0.06 mg.
There was a significant reduction in the eye dryness score in patients receiving OC-01 0.03 mg after 28 days, whereas patients receiving OC-01 0.06 mg had a nonsignificant reduction versus vehicle.
Between 62%-84% of patients receiving OC-01 experienced sneezing and 9%-25% experienced cough.
Reference
Wirta D, Torkildsen GL, Boehmer B, et al. ONSET-1 Phase 2b Randomized Trial to Evaluate the Safety and Efficacy of OC-01 (Varenicline Solution) Nasal Spray on Signs and Symptoms of Dry Eye Disease. Cornea. 2022 Oct 1;41(10):1207-1216. doi: 10.1097/ICO.0000000000002941. Epub 2021 Dec 21. PMID: 36107843.
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