Oyster Point Pharma, Inc., today announced results from the ONSET and RAINIER studies, two separate Phase 2b clinical trials evaluating the company’s novel therapies for the treatment of Dry Eye Disease (DED). Both studies, being presented tomorrow at the Ophthalmology Innovation Summit (OIS) meeting in Chicago, demonstrated improvement in Schirmer’s score and multiple measures of eye dryness symptoms.
The ONSET study was a dose-ranging, randomized, double-masked, vehicle-controlled Phase 2b clinical trial that evaluated the safety and efficacy of OC-01 in 182 subjects with DED in the United States. The study compared three different doses of OC-01 nasal spray to vehicle control nasal spray (1:1:1:1 randomization). The pre-specified primary endpoint was the assessment of tear production as measured by Schirmer’s score at Day 28 and the two pre-specified secondary endpoints were patient-reported symptoms of DED as measured by the Eye Dryness Scale (EDS) at Day 21 and Day 28.
Results showed a statistically significant improvement in Schirmer’s score at Day 28 in all three doses compared to control. Results indicated:
- 0.2% dose had a mean change in Schirmer’s score of 11.4 mm (p<0.001 vs. control);
- 0.1% dose had a mean change in Schirmer’s score of 11.8 mm (p<0.001 vs. control);
- 0.02% dose had a mean change in Schirmer’s score of 10.0 mm (p<0.001 vs. control).
- Vehicle control had a mean change in Schirmer’s score of 3.2 mm.
The RAINIER study was a randomized, double-masked, vehicle-controlled, Phase 2b clinical trial that evaluated the safety and efficacy of 2.0% OC-02 nasal spray in 53 subjects (2:1 randomization) with DED in the United States. The study’s sole pre-specified endpoint was the assessment of tear production as measured by Schirmer’s score at Day 28. Results demonstrated an increase in tear film production as measured by an improvement in Schirmer’s score in the study eye at Day 28 compared to vehicle control:
- OC-02 arm had a mean change in Schirmer’s score of 10.3 mm (p=0.08 vs. control)
- Vehicle control had a mean change in Schirmer’s score of 5.9 mm
OC-01 and OC-02 were well-tolerated with no significant ocular adverse events or drug-related serious adverse events. Adverse events were similar in both studies. The most common adverse events included sneeze, cough, and nose and throat irritation. These events were mild, self-limiting, and resolved immediately following administration.
See the full news release from Oyster Point Pharma, Inc.
Source: Oyster Point Pharma, Inc.