Oyster Point Pharma has announced that the Phase 3 ONSET-2 trial of the company’s OC-01 varenicline nasal spray for the treatment of dry eye disease met its primary endpoint, demonstrating significant improvement in tear film production as measured by Schirmer’s score for more patients using OC-01 than for patients using a control. A number of secondary endpoints were also met, the company said. Oyster Point announced the initiation of the ONSET-2 study in July 2019.
The ONSET-2 trial enrolled 758 subjects who received either 0.6 mg/ml or 1.2 mg/ml OC-01 or placebo twice daily for 4 weeks. At 4 weeks, the percentage of subjects that gained more than 10 mm on Schirmer’s score was 44% for the 0.6 mg/ml dose; 47% for the 1.2 mg/ml dose; and 26% for the control. Mean change from baseline at Week 4 for the 0.6 mg/ml dose was 11.0 mm; for the 1.2 mg/ml dose, mean change from baseline was 11.2 mm; and for the control, it was 5.9 mm.
Earlier this year, Oyster Point announced that the Phase 2 MYSTIC study of OC-01 for dry eye had met its primary endpoint. In that study, increase in tear film production at 84 days as measured by Schirmer’s score was also significantly higher for OC-01 than for control.
Oyster Point CEO Jeffrey Nau commented, “The ability to show statistically significant sign and symptom endpoints within the same clinical trial has been elusive in dry eye disease. ONSET-1 and ONSET-2 have independently met endpoints of both signs and symptoms in their respective trial populations. The ability to meet this high bar in the ONSET-2 population consisting of mild, moderate, and severe subjects is even more notable and speaks to the broad applicability of OC-01 to treat dry eye patients. We look forward to submitting the New Drug Application to FDA for OC-01 nasal spray to treat signs and symptoms of dry eye disease in the second half of 2020. If approved by the FDA, we remain on track for a planned US launch in the fourth quarter of 2021.”
Read the Oyster Point Pharma press release.
