Real-world study shows effectiveness of dry eye nasal spray
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OC-01 nasal spray, which was recently approved by the FDA, is an effective treatment for patients with varying severities of dry eye disease, according to a speaker at the European Society of Cataract and Refractive Surgeons meeting.
“Varenicline is a highly selective cholinergic agonist that stimulates natural tear production, and it is useful in the treatment of mild, moderate and severe disease,” Sheraz Daya, MD, FACP, FACS, FRCS(Ed), FRCOphth, said.
The phase 3 randomized ONSET-2 trial investigated the safety and efficacy of OC-01 (Tyrvaya (varenicline solution 0.03 mg, Oyster Point Pharma) in 758 patients. Patients were randomly assigned to receive OC-01 1.2 mg/mL, OC-01 0.6 mg/mL or vehicle control. The primary endpoint was the percentage of patients with a 10 mm or greater change from baseline in anesthetized Schirmer’s score, Daya said.
The real-world design of the study had no placebo run-in period, included subjects with a broad range of eye dryness scores and allowed patients to use artificial tears as often as they liked, Daya said.
“Significantly more treated subjects achieved a 10 mm or greater increase in Schirmer’s score vs. vehicle control at week 4 (P .01) in ONSET-1, ONSET-2 and integrated data,” Daya said.
Additionally, patients experienced statistically significant improvement in eye dryness score at week 4 in treated vs. control subjects (P < .05) in the 0.6 mg/mL cohort of ONSET-1, ONSET-2 and integrated data.
“We believe that this agent, in stimulating natural tears, has great promise in the future,” Daya said.
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Daya S. OC-01 nasal spray for the treatment of dry eye disease signs and symptoms in subjects with mild, moderate, and severe dry eye disease as determined by baseline eye dryness score: The ONSET-2 phase 3 study. Presented at: European Society of Cataract and Refractive Surgeons meeting; Oct. 8-11, 2021; Amsterdam.
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