Oyster Point Pharma has announced that the Phase 2b PEARL study of its OC-02 intranasal nicotinic acetylcholine receptor (nAChR) agonist for the treatment of dry eye disease demonstrated a statistically significant increase in production of tear film as well as a statistically significant reduction in symptoms for patients using OC-02 compared to placebo.
The dose-ranging, randomized, double-masked, vehicle-controlled PEARL study enrolled 165 patients with dry eye disease who received OC-02 in 0.2%, 1.0%, or 2.0% doses or placebo. Primary endpoints included increased tear production and reduction of patient-reported symptoms, both of which were met.
For the highest dose group, the mean change in Schirmer’s score, which measures tear production, was 19.3 mm compared to 2.6 mm for placebo, and the mean change in EDS score, which measure symptoms, was -19.0 vs -6.8 for placebo.
Oyster Point CEO Jeffrey Nau said, “We are excited by the results of the PEARL study. Showing a statistically significant improvement in both the signs and symptoms of dry eye within the same clinical trial validates the potential of stimulating the trigeminal parasympathetic pathway with this class of compound to increase natural tear film production. These results indicate a clear dose-response to OC-02 and suggest that this novel approach can stimulate tear production in dry eye patients with a broad range of baseline severity. We look forward to the continued development of both of our compounds, OC-02 and OC-01.”
Read the Oyster Point Pharma press release.
