By Chris Wack

 

Oyster Point Pharma Inc. said the U.S. Food and Drug Administration has approved Tyrvaya varenicline solution nasal spray 0.03 mg for the treatment of the signs and symptoms of dry eye disease.

The biopharmaceutical company said Tyrvaya nasal spray is the first and only nasal spray approved for the treatment of dry eye disease.

Oyster Point shares were halted at $13.60 in premarket trading.

Oyster Point said Tyrvaya is a highly selective cholinergic agonist delivered twice daily as an aqueous nasal spray into each nostril to activate basal tear production, and as a nasal spray administration treats dry eye disease without administering medication onto an already irritated ocular surface. Nasal delivery may allow some patients who have difficulty independently administering topical eye drops to administer independently their prescribed dry eye disease therapy, it said.

In trials, the mean change from baseline in Eye Dryness Score at week 4 was -18.9 mm in Tyrvaya-treated patients compared to -5.4 mm in vehicle-treated patients, the company said. This endpoint was met. The mean change from baseline in Eye Dryness Score at week 4 was -19.8 mm in Tyrvaya-treated patients compared to -15.4 mm in vehicle-treated patients. As that endpoint wasn't statistically significant, this secondary endpoint wasn't eligible for statistical testing and wasn't met.

Oyster Point said the most common adverse reaction reported in 82% of patients was sneezing. Events that were reported in 5% to 16% of patients were cough, throat irritation, and instillation-site irritation.

Tyrvaya nasal spray will be available with a prescription in November in cartons containing two multidose nasal spray bottles. Each nasal spray bottle covers treatment for 15 days, administered twice daily into each nostril. Samples that provide 15 days of treatment will also be made available to eye care providers.

 

Write to Chris Wack at chris.wack@wsj.com

 

(END) Dow Jones Newswires

October 18, 2021 06:45 ET (10:45 GMT)

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