Tear production and patient-reported symptoms were improved in patients with self-reported autoimmune diseases with dry eye disease (DED) treated with OC-01 (varenicline solution) nasal spray, according to a post hoc subgroup analysis from the Phase 2b ONSET-1 trial and the Phase 3 ONSET-2 trial.
Of the 891 participants in the trial, 31 reported having an autoimmune disease. The therapeutic effect of the nasal spray was consistent in patients with and without autoimmune diseases.
Mean change in Schirmer test with anesthesia score (STS, mm) and Eye Dryness Score from baseline to 28 days was compared between the treatment and vehicle control groups. Amongst patients with an autoimmune disease, the difference in STS score was 11.8 mm and in Eye Dryness Score was -9.3. The difference in the proportion of patients with ≥10 mm STS improvement was 61.1%.
Most patients (82-84%) experienced an adverse event of sneezing, although it was graded as mild by nearly all (98%).
Reference
Schallhorn JM, McGee S, Nau 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. Clin Ophthalmol. 2023;17:725-734. doi: 10.2147/OPTH.S403953. PMID: 36895950; PMCID: PMC9990452.
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