OC-01, a varenicline nasal spray for the treatment of ocular surface diseases, was safe and well tolerated in a phase 1 study, Oyster Point Pharma announced in a press release.
The open-label, single-center, randomized, two-way crossover ZEN study assessed the relative bioavailability of OC-01 at its highest intended clinical strength (varenicline 1.2 mg/mL in a 50 µL nasal spray) compared with Chantix (varenicline 1 mg oral tablet, Pfizer) in 22 healthy volunteers.
Topline results of the study found OC-01 nasal spray to be safe and well tolerated with no serious adverse events.
Mild adverse events occurred in 13 of 21 subjects after use of the nasal spray compared with nine of 22 subjects after use of Chantix, with the most common adverse events after nasal spray use being sneeze and cough.
“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,” Jeffrey Nau, PhD, MMS, Oyster Point’s president and CEO, said in the release.