OC-01 nasal spray shows benefits in patients with autoimmune disease and dry eye disease
August 31, 2022
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Schallhorn J, et al. OC-01 (varenicline solution) nasal spray for the treatment of signs and symptoms of dry eye in subjects with autoimmune disease: integrated data from ONSET-1 and ONSET-2. Presented at the Summer Symposium on Women in Ophthalmology; August 25-28, 2022; Monterey, California (hybrid meeting).
Disclosures: Schallhorn reports that he is an investigator for Oyster Point Pharma, a consultant for Zeiss and Vanda Pharmaceuticals, and a shareholder in Long Bridge Medical and Octavia.
MONTEREY, Calif. – OC-01 Nasal Spray has shown a significant decrease in signs and symptoms of dry eye disease in patients with autoimmune disease and associated dry eye disease.
The study was presented as a poster by Julie Schallhorn, MD, MS, and co-authors of 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 nasal spray (varenicline solution , Oyster Point Pharma) 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 strengths or the 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 lupus disseminated erythematosus. These patients, the authors wrote, are more likely to have more severe DED. Outcome measures from baseline to week 4 included Schirmer’s test score (STS), mean change in dry eye score (EDS), and patient-reported dry eye discomfort measure .
The treatment showed consistent benefits in STS and EDS results. Improvement in STS greater than 10 mm was achieved in 61.1% of patients in the treatment group versus 0% in the vehicle control group. The mean change in STS was 13.6 mm with treatment and 1.8 mm with vehicle control. The mean change in EDS was -19.6 with treatment versus -10.3 with vehicle control. According to the study, the treatment was well tolerated, and the most common adverse events were mild sneezing, coughing, and throat or nose irritation.
“Activation of cholinergic agonists in the nasal cavity provides an alternative treatment modality for people with AID with DED,” the authors wrote. “Future prospective studies with larger AID subject samples are recommended,” they added.