OC-01 nasal spray shows benefits in patients with autoimmune disease and dry eye
Click Here to Manage Email Alerts
MONTEREY, Calif. — OC-01 nasal spray showed a significant decrease in the signs and symptoms of dry eye in patients with autoimmune disease and associated dry eye disease.
The study was presented in a poster by Julie Schallhorn, MD, MS, and co-authors at the Women in Ophthalmology 2022 Summer Symposium. A subpopulation of patients with autoimmune disease (AID) was selected from the ONSET-1 and ONSET-2 studies that previously evaluated the safety and efficacy of OC-01 (varenicline solution, Oyster Point Pharma) nasal spray in dry eye disease (DED). In the two studies, 182 and 758 patients, respectively, were randomized 1:1:1:1 to receive either the nasal spray at three different concentrations or vehicle control. Investigators performed a secondary analysis for 31 patients with AID, including rheumatoid arthritis, Sjogren’s syndrome, autoimmune thyroiditis, colitis, Chron’s disease, multiple sclerosis, psoriasis and systemic lupus erythematosus. These patients, the authors wrote, are more likely to have worse DED. Outcome measures from baseline to week 4 included Schirmer's test score (STS), mean change in eye dryness score (EDS) and patient-reported measure of discomfort from dry eye.
The treatment showed consistent benefits in STS and EDS outcomes. Improvement in STS of greater than 10 mm was achieved by 61.1% of patients in the treatment group vs. 0% in the vehicle control group. The mean change in STS was 13.6 mm with treatment and 1.8 mm with vehicle control. Mean change in EDS was –19.6 with treatment vs. –10.3 with vehicle control. According to the study, the treatment was well tolerated, and the most common adverse events were mild sneeze, cough, and throat or nose irritation.
“Cholinergic agonist activation in the nasal cavity provides an alternate treatment modality for those affected by AID with DED,” the authors wrote. “Future prospective studies with larger AID subject sample sizes are recommended,” they added.
Collapse
Schallhorn J, et al. OC-01 (varenicline solution) nasal spray for the treatment of dry eye disease signs and symptoms in subjects with autoimmune disease: Integrated data from ONSET-1 and ONSET-2. Presented at: Women in Ophthalmology Summer Symposium; Aug. 25-28, 2022; Monterey, California (hybrid meeting).
Read more about
Click Here to Manage Email Alerts