Oyster Point Pharma meets primary endpoint in dry eye nasal spray study
A potential nasal spray treatment for dry eye signs and symptoms met its primary endpoint of increased Schirmer’s score in a phase 3 trial, Oyster Point Pharma announced in a press release.
The multicenter, double-masked, randomized, controlled ONSET-2 trial evaluated safety and efficacy of OC-01 (varenicline) nasal spray, a selective nicotinic acetylcholine receptor agonist, at two doses compared with vehicle in 758 patients.
Twice daily dosing of both a 0.6 mg/mL dose and a 1.2 mg/mL dose yielded statistically significant greater improvement of at least 10 mm on Schirmer’s score at 4 weeks compared to controls: 44% vs. 47% vs. 26%, respectively (P < .0001). Average increases in Schirmer’s scores were 11 mm in the 0.6 mg/mL group, 11.2 mm in the 1.2 mg/mL group and 5.9 mm in the control group.
The secondary endpoint of improvement in eye dryness score was met in the 1.2 mg/mL group at week 2 (P = .009) and week 4 (P = .002).
The company intends to submit a new drug application in 2020.