The following are the study results showing efficacy of a dry eye nasal spray.
Patients treated with the nasal spray experienced improvement in symptoms of dry eye disease by day 28 of treatment, according to a research study.
Nasal spray improves indicators, symptoms of dry eye disease
An ophthalmologist, went over the outcomes of the ONSET-2 stage 3 research study of OC-01 (varenicline, Oyster Point Pharma) at the virtual association for Research in Vision and Ophthalmology meeting.
“OC-01 varenicline, a novel compound delivered via nasal spray, is a very selective nicotinic acetylcholine receptor agonist that activates the trigeminal parasympathetic path that stimulates the lacrimal functional unit to restore the natural tear film,” he stated.
Researchers arbitrarily appointed 758 patients to receive a couple of doses of OC-01 nasal spray (0.6 mg/mL, 260 patients; or 1.2 mg/mL, 246 patients) or placebo (252 patients) two times daily for 28 days. They examined the spray’s effectiveness using anesthetized Schirmer’s test score and Eye Dryness Score (EDS, 0 to 100 range) at day 28.
Patients treated with OC-01 experienced better improvement in Schirmer’s test score, with a gain of 10 mm or more from baseline by day 28, compared with patients that got placebo.
In the 0.6 mg/mL group, 47.3% of eyes showed improvement, while 49.2% of eyes in the 1.2 mg/mL team showed improvement. In the placebo group, 27.8% showed improvement (both P <.0001). Mean change in Schirmer’s test score in each OC-01 team was 11.3 mm and 11.5 mm, respectively, compared to 6.3 mm in the placebo group (both P <.0001).
Both OC-01 teams also experienced a better reduction in EDS from baseline at week 2 (0.6 mg/mL,- 16.5 mm, P <.05; 1.2 mg/mL,- 17.9 mm, P =.0078; placebo,- 12.7 mm) and also week 4 (0.6 mg/mL,- 19.8 mm, P <.05; 1.2 mg/mL,- 22.2 mm P =.0014; placebo,- 15.4 mm).
The most common adverse event was sneezing.