Oyster Point Pharma Announces Publication in Ophthalmology of ONSET-2 Phase 3 Data on Tyrvaya Nasal Spray
Oyster Point Pharma announced that results from the multicenter, randomized, double-masked, vehicle-controlled phase 3 clinical trial (The ONSET-2 study) of Tyrvaya Nasal Spray (varenicline solution) have been published in Ophthalmology.1 Tyrvaya (varenicline solution) Nasal Spray 0.03 mg is a highly selective cholinergic agonist that is FDA-approved to treat the signs and symptoms of dry eye disease as a multidose nasal spray.
“This phase 3 study of Tyrvaya nasal spray shows consistent outcomes as compared to the ONSET-1 phase 2b trial. These results show clinically meaningful improvements in basal tear film production,” Jeffrey Nau, PhD, MMS, President and Chief Executive Officer of Oyster Point Pharma, said in a company news release. "These results are notable as Tyrvaya is the first and only cholinergic agonist nasal spray approved by the FDA to treat patients with the signs and symptoms of dry eye disease, leveraging this novel mechanism of action of activating the trigeminal parasympathetic pathway.”
About ONSET-2 Study
The ONSET-2 phase 3 pivotal clinical study was a multicenter, randomized, double-masked, vehicle-controlled trial in adult subjects at least 22 years of age with dry eye disease in the US. The main eligibility criteria for the studies included a physician’s diagnosis of dry eye disease, a baseline Schirmer’s Score of <10 mm. Patients could have an Eye Dryness Score from 0-100 mm (visual analog scale). Tyrvaya Nasal Spray was administered as a single spray into each nostril twice-daily. The primary and key secondary endpoints, including improvement in Schirmer’s Score and Eye Dryness Score (EDS) as compared to vehicle control, were measured at Day 28. The ONSET-2 study of Tyrvaya Nasal Spray enrolled a broad population of mild, moderate, and severe dry eye disease subjects, as measured by Eye Dryness Score at baseline (range 2-100 mm).