Oyster Point Pharma has announced top-line results from the Phase 1 ZEN study of its OC-01 varenicline nasal spray, which the company is developing for the treatment of dry eye disease. The PK study, which enrolled 22 healthy volunteers, compared OC-01 to Chantix varenicline tablets.
Systemic exposure was found to be 13 times lower for the highest strenght of the OC-01 nasal spray compared to the highest strength of Chantix, and Cmax was 14 times lower for the nasal spray compared to the Chantix tablet. For all doses tested, OC-01 was found to be safe and well tolerated. Four of the volunteers in the oral group experienced vomiting; none of the volunteers in the OC-01 group experienced nausea or vomiting.
Oyster Point President and CEO Jeffrey Nau said, “We are pleased by the positive results of the ZEN study as they confirm and validate the pharmacokinetic profile and the fundamental science of our OC-01 nasal spray. OC-01 nasal spray is designed to deliver a concentrated local dose of drug to the nasal mucosa, stimulating the trigeminal nerve to produce natural tear film, while limiting the systemic exposure.”
Read the Oyster Point Pharma press release.
