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Michael Raizman, Jeffrey Nau, Andrea Gibson, Puja Shah; ONSET-2 Phase 3 Study of OC-01 Nasal Spray for the Treatment of Dry Eye Disease. Invest. Ophthalmol. Vis. Sci. 2021;62(8):1331.
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Tear film instability leads to symptoms of ocular discomfort and signs of decreased tear production. OC-01 (varenicline), a novel compound delivered via nasal spray, is a nicotinic acetylcholine receptor agonist that activates the trigeminal parasympathetic pathway to stimulate the lacrimal functional unit to reestablish the natural tear film. This Phase 3 study (ONSET-2) evaluated the efficacy and safety of OC-01 in treating the signs and symptoms of dry eye disease (DED).
The study randomized 758 subjects at a 1:1:1 ratio to receive 0.6 mg/mL OC-01 nasal spray (N=260), 1.2 mg/mL OC-01 nasal spray (N=246), or placebo (vehicle) nasal spray (N=252) twice daily for 28 days. Outcome measures included anesthetized Schirmer’s Test Score (STS) and Eye Dryness Score (EDS, 0-100 scale) at Day 28.
Subjects treated with OC-01 nasal spray showed statistically significant improvement compared with placebo as indicated by a gain in STS of ≥10 mm from baseline by Day 28. The percentage of eyes showing improvement in the 0.6 mg/mL, 1.2 mg/mL, and placebo groups were: 47.3% (p<0.0001 compared to placebo), 49.2% (p<0.0001) and 27.8%, respectively. Mean change in STS was 11.3 mm (p<0.0001), 11.5 mm ((p<0.0001), and 6.3 mm, respectively (Fig.1). A robust and (nominally) significant reduction in EDS from baseline was demonstrated with 0.6 mg/mL and 1.2 mg/mL compared to placebo at Week 2 of -16.5 mm (p<0.05), -17.9 mm (p=0.0078) and -12.7 mm; and at Week 4 of -19.8 mm (p<0.05), -22.2 mm (p=0.0014), and -15.4 mm, respectively (Fig.2). The improvement in EDS at Day 28 was evident, regardless of baseline EDS categorization, indicating that OC-01 would benefit a broad population of DED patients. The most common adverse event in the 0.6 mg/mL and 1.2 mg/mL groups was sneezing (95.0% and 96.7%, respectively).
Compared to placebo, OC-01 nasal spray demonstrated improvement in both signs and symptoms of DED by Day 28 despite baseline EDS and has an excellent safety and tolerability profile under conditions of the study.
This is a 2021 ARVO Annual Meeting abstract.
Fig. 1 ONSET-2: Percentage of subjects with ≥10mm change from baseline in STS study eye at Week 4 (ITT Population, LOCF).
Fig. 2 ONSET-2: Mean change from baseline of EDS at Week 1,2, & 4 (ITT Population, LOCF).
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