Oyster Point Pharma, Inc. (NASDAQ: OYST) announced the positive top-line results from its Phase 2 MYSTIC study in Dry Eye Disease.
"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," said Dr. Preeya Gupta, Associate Professor of Ophthalmology at Duke University Eye Center and member of Oyster Point Pharma's medical advisory board. "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."
Efficacy and Safety Results
Results showed a statistically significant improvement in Schirmer's score from baseline at Day 84 in both doses as compared to control.
Results for the study eye (primary endpoint) indicated:
The 1.2 mg/ml dose had a mean change in Schirmer's score of 11.0 mm (p<0.05 vs. control);
The 0.6 mg/ml dose had a mean change in Schirmer's score of 10.6 mm (p<0.05 vs. control).
The vehicle control group had a mean change in Schirmer's score of 6.2 mm.
In the eye that was not designated as the study eye (fellow eye), results were consistent (exploratory endpoint):
The 1.2 mg/ml dose had a mean change in Schirmer's score of 10.0 mm (p=0.01 vs. control);
The 0.6 mg/ml dose had a mean change in Schirmer's score of 8.7 mm (p<0.05 vs. control).
The vehicle control group had a mean change in Schirmer's score of 4.5 mm.
The study demonstrated that OC-01 nasal spray was well-tolerated at the two doses tested. The number of subjects reporting any treatment-emergent adverse event (TEAE) was 10 out of 41 (24% percent) in each OC-01 nasal spray dose group and 10 out of 41 (24% percent) in the vehicle control group. There were no reports of serious TEAE in the study and no serious adverse events related to study drug administration. The most common adverse events in the nasal spray groups were blurry vision, sneezing, and headache. All events were mild in the OC-01 nasal spray groups and resolved by the next visit.
"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," said Dr. Jeffrey Nau, CEO of Oyster Point Pharma. "We look forward to discussing top-line data from our Phase 3 ONSET-2 study in Dry Eye Disease in mid-2020."
The MYSTIC Study
The MYSTIC study was a randomized, single-masked, vehicle-controlled Phase 2 clinical trial that evaluated the safety and efficacy of OC-01 in 123 subjects with Dry Eye Disease at the Asociación para Evitar la Ceguera (APEC) in Mexico City. APEC is the largest specialized ophthalmology hospital in North America by patient volume. The study compared two different doses of OC-01 nasal spray to vehicle control nasal spray (1:1:1 randomization). The goal of this study was to assess the safety and efficacy of twice daily dosing of OC-01 nasal spray administered for 84 days. The pre-specified primary endpoint was the assessment of tear production as measured by mean change in Schirmer's score at Day 84 as compared to vehicle cont