Investigational nasal spray for dry eye disease scores high in phase II trial

The single-dose nicotinic acetylcholine receptor (nAChR) agonist OC-02 (simpinicline solution), administered as an aqueous nasal spray, helps increase tear production and improve eye dryness in patients with dry eye disease (DED), according to data from the phase II PEARL trial.

PEARL included 165 patients aged ≥22 years and who had an Ocular Surface Disease Index score ≥23, corneal fluorescein staining score ≥2 in >1 region or ≥4 for all regions, or Schirmer test score (STS) ≤10 mm. They were randomized to receive vehicle treatment (control; n=42) or OC-02 SNS (0.11 mg, 0.55 mg, or 1.1 mg; n=41 per group). Treatment was given in single dose (100 µL using a nasal spray atomizer) at visit 1 and visit 2 (15–19 days after visit 1).

The primary efficacy outcomes were change in the STS from baseline to immediately after treatment administration (visit 1) and change in the eye dryness score from before to 5 minutes after treatment during controlled adverse environment exposure (visit 2).

There were no significant differences in baseline demographic and ocular clinical characteristics in the treatment groups. Single-dose OC-02 SNS improved the signs and symptoms of DED as compared with vehicle.

For the STS, OC-02 SNS delivered statistically significant and dose-dependent improvements versus vehicle (least-squares mean change from baseline: vehicle, 3.0 mm; 0.11 mg OC-02 SNS, 9.0 mm; 0.55 mg, 17.5 mm; and 1.1 mg, 19.6 mm).

Likewise, for EDS, the investigational drug at higher doses produced statistically significant and dose-dependent improvements from before to 5 minutes after treatment (least-squares mean change from baseline: vehicle, –6.5; 0.11 mg OC-02 SNS, –9.4; 0.55 mg, –17.4; and 1.1 mg, –20.7).

OC-02 SNS was well tolerated, with only two ocular adverse events documented. One was eye pruritis, while the other was keratitis. The most common nonocular events were cough and throat irritation.