Nasal spray improves dry eye symptoms regardless of severity
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BOSTON – Treatment with OC-01 nasal spray showed significant improvements in dry eye disease signs and symptoms, according to a data review presented at the American Academy of Optometry annual meeting.
“Most recently, dry eye diseases have been defined as a multifactorial disease characterized by an unstable or deficient tear film and accompanied by loss of homeostasis; therefore, the goal for dry eye should be to reestablish the tear film and restore homeostasis,” Leslie O’Dell, OD, FAAO, clinical director at Medical Optometry America in Shrewsbury, Pa., said during an academy-sponsored press conference.
To determine the effect of OC-01 (varenicline, Oyster Point Pharma) on dry eye disease outcomes, O’Dell and colleagues analyzed integrated data from the ONSET-1 phase 2b and ONSET-2 phase 3 clinical trials.
“The proposed mechanism of action of OC-01 nasal spray is to lead to an increase in basal tear production,” O’Dell said.
Results showed that both patients treated with the 0.6 mg/mL solution and those treated with the 1.2 mg/mL solution of varenicline had increases in mean Schirmer’s Test Score and Eye Dryness Score from baseline to week 4 compared with vehicle control (P < .01).
The mean change was significant regardless of baseline test score severity.
Most patients in the 0.6 mg/mL group (82%) and in the 1.2 mg/mL group (84%) reported a sneeze, which 98% rated as mild, compared with 22.4% of participants in the vehicle control group who reported a sneeze.
Other treatment-related adverse events included cough and irritation to the throat and instillation site, which occurred in less than 5% of patients.
“OC-01 is a highly selective cholinergic agonist that utilizes the trigeminal parasympathetic pathway to pharmacologically neuro-activate natural tear production,” O’Dell said. “With its safe profile and novel approach it is something to keep watch for.”
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O’Dell L, et al. Effect of OC-01 (varenicline) nasal spray compared to vehicle (control) on dry eye disease sign outcomes by baseline subgroup characteristics. Presented at: American Academy of Optometry annual meeting; Nov. 2-6, 2021; Boston.
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