Integrated clinical trial data show efficacy, safety of nasal spray for dry eye
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Integrated data from the phase 2 ONSET-1 and phase 3 ONSET-2 clinical trials showed that OC-01 nasal spray effectively improves endogenous basal tear production in a heterogeneous dry eye disease population.
The results of this analysis were presented in a poster session at the American Academy of Ophthalmology meeting by John Sheppard, MD.
“Tear film homeostasis is controlled by the parasympathetic nervous system. A loss of parasympathetic stimuli results in chronic reduction of tear secretion and morphologic destruction of the lacrimal gland,” Sheppard said.
OC-01 (varenicline solution, Oyster Point Pharma) is a selective nicotinic acetylcholine receptor agonist able to stimulate the cholinergic receptors within the trigeminal nerve, leading to parasympathetic activation of the lacrimal functional unit and consequent increase in basal tear film production. With one spray in each nostril, twice a day, about 12 hours apart, it may provide a novel and easy way of reducing dry eye signs and symptoms.
OC-01, now known as Tyrvaya, was approved by the FDA in October 2021.
The ONSET-1 and ONSET-2 studies enrolled 182 and 758 subjects, respectively. In both studies, mean change from baseline in Schirmer’s tests score (STS) at week 4 was evaluated with two dose concentrations (0.03 mg and 0.06 mg) vs. vehicle control in subjects with dry eye disease.
By combining the data of the two studies, mean change of STS at week 4 was determined according to stratification factors and subgroups at baseline, namely STS of 5 mm or less and greater than 5 mm, eye dryness score less than 60 and 60 or greater, and inferior corneal fluorescence staining less than 1.5 and 1.5 or greater.
“Consistency of improvement was demonstrated with both formulations regardless of baseline stratification severity factors and subgroups,” Sheppard said. In about half of the patients across both the most severe and the least severe baseline groups, STS improved by at least 10 mm.
The treatment showed a favorable safety and tolerability profile. The most common adverse events were sneeze after nasal spray administration in just more than 80% of the subjects and nose and throat irritation in more than 5%.
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Sheppard J, et al. OC-01 (varenicline solution) nasal spray clinical sign outcomes in dry eye disease by baseline stratification factors and subgroups: Combined ONSET-1 and ONSET-2. Presented at: American Academy of Ophthalmology meeting; Nov. 12-15, 2021; New Orleans.
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