Oyster Point Announces Enrollment of First Subject in Phase 3 Clinical Trial of Nasal Spray for Dry Eye Disease

Oyster Point Pharma announced enrollment of the first subject in the phase 3 ONSET-2 clinical trial of OC-01 nasal spray for the treatment of the signs and symptoms of dry eye disease.

“After successfully completing our registrational phase 2b clinical trial, ONSET-1, we are excited to announce the initiation of our second registrational trial, ONSET-2,” Jeffrey Nau, PhD, MMS, President and CEO of Oyster Point Pharma, said in a company news release. “We believe OC-01 has the potential to change the way that eye care practitioners treat patients with dry eye disease due to the rapid onset of action in increasing natural tear film production, the ability to significantly improve both signs and symptoms of dry eye disease, and a favorable tolerability profile. The novel delivery of OC-01 as a nasal spray spares the ocular surface and enables our innovative mechanism of action, providing eye care practitioners and patients unique benefits.”

The ONSET-2 trial is a multicenter, randomized, double-masked, placebo-controlled clinical trial to evaluate the safety and efficacy of OC-01 nasal spray for treating the signs and symptoms of dry eye disease. The study, which will enroll approximately 750 subjects at approximately 20 U.S. centers, will investigate two doses of OC-01 nasal spray, 0.6mg/ml and 1.2 mg/ml, as compared to placebo (vehicle) nasal spray. The pre-specified primary endpoint of the trial will be the assessment of tear production as measured by the percentage of subjects with a 10 mm or greater change from baseline Schirmer’s Score at Week 4. Secondary symptom endpoints will be the assessment of patient-reported symptoms of dry eye disease as measured by the Eye Dryness Scale (EDS) at Week 4.

In October 2018, Oyster Point reported results from the phase 2b ONSET-1 clinical trial in which OC-01 demonstrated statistically significant improvements in both the pre-specified primary sign endpoint and multiple pre-specified secondary symptom endpoints as compared to placebo (vehicle). OC-01 was well-tolerated with no significant ocular adverse events or serious drug-related adverse events. The most common adverse events included sneeze, cough, and nose and throat irritation. These events were mild, self-limiting, and resolved immediately following administration.

“It’s encouraging to see the progress Oyster Point is making in the development of OC-01,” Elizabeth Yeu, MD, an ophthalmologist at Virginia Eye Consultants, and member of Oyster Point Pharma’s medical advisory board, said in the news release. “There is a significant need for more therapeutic options that can successfully benefit a broad population of patients with dry eye disease. OC-01 addresses a fundamental aspect of the disease, and I believe it has the potential to become a new standard of care.”