Recently, OysterPoint Pharmaceuticals announced that the FDA has approved Tyrvaya (varenicline) nasal spray NDA for the treatment of dry eye syndrome (DED). This is the first approved nasal spray for dry eye syndrome. The approval of this drug fills in Nasal spray is blank in the treatment of dry eye syndrome.

Dry eye is an eye disease with dysfunction of tear secretion with dry eyes as the main symptom. It is often accompanied by itchy eyes, foreign body sensation, burning sensation, or photophobia, blurred vision, and fluctuations in vision. Unstable tear film is one of the main causes of dry eye. Human tear film contains many different proteins, growth factors and antibodies, which can protect and lubricate the eyes.

Tyrvaya nasal spray can be used to treat dry eye. It is a highly selective cholinergic agonist that binds to neuronal nicotinic acetylcholine (nACh) receptors to activate the trigeminal nerve parasympathetic pathway, thereby stimulating basal tears (basal tear) is generated.

Relevant statistics, Tyrvaya prescription information The efficacy of Tyrvaya nasal spray is based on two multi-center, randomized, double-blind, placebo clinical studies conducted by more than 1,000 patients with mild/moderate/severe dry eye. The production of basal tears is measured by the change in the Schirmer score of anesthesia from the baseline, and the degree of eye dryness is measured by the change in the baseline of the dry eye score. This is a visual analog scale in which the patient scores the degree of dryness and discomfort of the eyes. The greater the decrease in the score, the greater the relief of symptoms.

The results of the test showed that at the fourth week of treatment, in the ONSET-1 trial, 52% of the Tyrvaya drug group patients had a Schirmer score increase of ≥10 mm from baseline. In the ONSET-2 trial, 47% of the Tyrvaya drug group patients had a better score. The baseline increase was ≥10mm, compared to 14% and 28% in the control group (p<0.01). In terms of safety, sneezing was the most common adverse reaction in 82% of patients, and coughing, throat irritation and irritation at the drip site were found in 5-16% of patients.

Reference source:

[1] https://www.tyrvaya-pro.com/files/prescribing-information.pdf

[2] OysterPoint Pharma Announces FDA Approval of TYRVAYA™ (varenicline solution) Na(multivu.com)