Oyster Point Pharma reported positive preliminary results from a phase 2b trial testing their novel drug for dry eye disease.

Delivered as a nasal spray, OC-02 is a small-molecule nicotinic acetylcholine receptor agonist that stimulates the trigeminal parasympathetic pathway to increase natural tear film production.

“There is a significant unmet need for effective dry eye treatments that offer immediate results and a favorable safety profile,” said Edward Holland, MD, professor of ophthalmology at the University of Cincinnati and a medical advisory board member at Oyster Point Pharma. “These preliminary findings are an encouraging step forward for this novel pharmaceutical that could change how we approach the treatment of dry eye disease.”

In the double-masked phase 2b trial, 165 patients with dry eye were randomized to receive 3 different doses of OC-02 (0.2%, 1.0%, or 2.0%) or placebo. Researchers observed a significant, dose-dependent increase in tear production in all 3 treatment groups. The largest mean change in Schrimer’s score was seen with the 2.0% OC-02 dose (19.3 vs 2.6 mm for controls; P<0.0001). Patient-reported symptoms were significantly improved in the 1.0% and 2.0% groups, but not in the 0.2% group.

No ocular or drug-related serious adverse events were observed. The nasal spray did, however, cause some mild and transient events such as coughing and nose and throat irritation.

According to CEO Jeffrey Nau, PhD, the results indicate a clear dose-response to OC-02, and hint at the drug’s efficacy for alleviating dry eye signs and symptoms. The company is also developing another nasally delivered, nicotinic acetylcholine receptor agonist for dry eye, OC-01, which recently received the FDA’s investigational new drug application. The New Jersey-based biotech has not disclosed how the 2 compounds differ from each other.