Oyster Point Pharma 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, presented at the Ophthalmology Innovation Summit (OIS) meeting in Chicago, demonstrated improvement in Schirmer’s score and multiple measures of eye dryness symptoms.
“The results announced today demonstrate the potential clinical benefits of the innovative therapeutics Oyster Point Pharma is developing,” Dr. Edward Holland, Professor of Ophthalmology, University of Cincinnati and member of Oyster Point Pharma’s medical advisory board, said in a company news release. “There is a significant need for a novel treatment approach for dry eye disease. A therapeutic that can help patients to produce their own natural tear film has the potential to benefit a broad population of patients with dry eye disease.”
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.
Results were similar in the fellow eyes (P<0.001).
Both pre-specified secondary endpoints were also met, as indicated by a statistically significant improvement in mean change in EDS score in a controlled adverse environment at Day 21 (P<0.05), and a statistically significant improvement compared to control (P<0.05) in the mean change in EDS score at Day 28 without use of a controlled adverse environment.
“We are excited about the ability for both of our investigational compounds to show improvements in both the signs and symptoms of Dry Eye Disease,” Dr. Jeffrey Nau, CEO of Oyster Point Pharma, said in a company news release. “We look forward to initiating a phase 3 program in dry eye disease in 2019 after discussion with regulatory authorities.”
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
Results were similar in the fellow eyes (P<0.05).
Although not powered to show statistical significance on exploratory symptoms endpoints, OC-02 showed improvements in mean EDS and Ocular Discomfort Score (ODS) compared to vehicle control.
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.