Oyster Point Pharma has announced the initiation of the Phase 3 ONSET-2 study of its OC-01 nicotine acetylcholine receptor (nAChR) agonist nasal spray for the treatment of dry eye disease. In October 2018, the company announced positive Phase 2b results for both OC-01 and OC-02 nasal sprays for that indication. Earlier this year, Oyster Point said that it had raised $93 million for Phase 3 development of both nasal sprays.
The ONSET-2 study, which is expected to enroll approximately 750 subjects, will compare the efficacy of two doses of OC-01 to a placebo nasal spray in increasing tear production and reduction of patient-reported dry eye disease symptoms.
Oyster Point Pharma President and CEO Jeffrey Nau commented, “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. 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.”
Read the Oyster Point Pharma press release.
