According to Oyster Point Pharma, the Phase 2 MYSTIC study of its OC-01 varenicline nasal spray for the treatment of dry eye disease met its primary endpoint, demonstrating significant improvement in tear production at Day 84 compared to control as measured by Schirmer’s score. Both doses tested met that endpoint, with a 1.2 mg/ml dose achieving an 11.0 mm mean change in Schirmer’s score and a 0.6 mg/ml dose achieving a 10.6 mm mean change versus a mean change of 6.2 mm for the control in the study eye.
The MYSTIC study, which enrolled 123 patients, also found that each of the two doses produced comparable results in the non-study eye compared to a vehicle control nasal spray. OC-01 was well tolerated at both dose levels.
In November 2019, Oyster Point announced positive results from the Phase 1 ZEN study of OC-01. The company announced initiation of the Phase 3 ONSET-2 study of OC-01 in July 2019.
Oyster Point CEO Jeffrey Nau said, “We are excited to further validate the ability of OC-01 nasal spray to stimulate an increase in tear film production that is sustained over the course of twice daily dosing for 84 days in subjects with dry eye disease from the MYSTIC study. We look forward to discussing top-line data from our Phase 3 ONSET-2 study in dry eye disease in mid-2020.”
Medical advisory board member Preeya Gupta of Duke University Eye Center commented, “The results from the MYSTIC study further validate the novel mechanism of action of OC-O1 nasal spray and its ability to stimulate natural tear production via the trigeminal parasympathetic pathway. There is a significant need for a treatment approach that can be delivered chronically through a novel route of administration that allows patients to stimulate their own natural tear film and address the underlying disease process.”
Read the Oyster Point Pharma press release.
