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# Oyster Point Nasal Spray for Dry Eye OK’d
- URL: https://www.fdaweb.com/oyster-point-nasal-spray-for-dry-eye-okd/
- Published: 2021-10-19T12:00:00.000Z
- Updated: 2026-09-14T17:19:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150394

FDA has approved an Oyster Point Pharma NDA for Tyrvaya (varenicline solution) nasal spray 0.03 mg for treating signs and symptoms of dry eye disease. The product is believed to “bind to cholinergic receptors to activate the trigeminal parasympathetic pathway resulting in increased production of basal tear film as a treatment for dry eye disease,” the company says.

Approval was based on data from the the ONSET-1, ONSET-2, and MYSTIC clinical trials in over 1,000 patients with mild, moderate or severe dry eye disease. Tyrvaya-treated patients showed statistically significant improvements in tear film production as assessed using the anesthetized Schirmer’s score at week 4, the company says. The most common adverse reaction reported in 82% of patients was sneezing, and events reported in 5-16% of patients were cough, throat irritation, and nose irritation, it adds.