Association for Research in Vision and Ophthalmology

Association for Research in Vision and Ophthalmology

Source:

Raizman M, et al. ONSET-2 phase 3 study of OC-01 nasal spray for the treatment of dry eye disease. Presented at: Association for Research in Vision and Ophthalmology annual meeting; May 1-7, 2021 (virtual meeting).

Disclosures: Raizman reports he is a consultant for Oyster Point.
June 04, 2021
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Nasal spray improves signs, symptoms of dry eye disease

Source:

Raizman M, et al. ONSET-2 phase 3 study of OC-01 nasal spray for the treatment of dry eye disease. Presented at: Association for Research in Vision and Ophthalmology annual meeting; May 1-7, 2021 (virtual meeting).

Disclosures: Raizman reports he is a consultant for Oyster Point.
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Patients treated with a nasal spray experienced improvement in signs and symptoms of dry eye disease by day 28 of treatment, according to a study.

Michael Raizman, MD, discussed the results of the ONSET-2 phase 3 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 highly selective nicotinic acetylcholine receptor agonist that activates the trigeminal parasympathetic pathway that stimulates the lacrimal functional unit to reestablish the natural tear film,” he said.

Researchers randomly assigned 758 patients to receive one of two doses of OC-01 nasal spray (0.6 mg/mL, 260 patients; or 1.2 mg/mL, 246 patients) or placebo (252 patients) twice daily for 28 days. They assessed the spray’s efficacy using anesthetized Schirmer’s test score and Eye Dryness Score (EDS, 0 to 100 scale) at day 28.

Patients treated with OC-01 experienced greater improvement in Schirmer’s test score, with a gain of 10 mm or more from baseline by day 28, compared with patients who received 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 group showed improvement. In the placebo group, 27.8% showed improvement (both P < .0001). Mean change in Schirmer’s test score in each OC-01 group was 11.3 mm and 11.5 mm, respectively, compared with 6.3 mm in the placebo group (both P < .0001).

Both OC-01 groups also experienced a greater 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 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.