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FDA approves Oyster Point’s nasal spray for dry eye disease By Reuters

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© Reuters. FILE PHOTO – Signage outside the Food and Drug Administration headquarters in White Oak (Maryland, U.S.A), August 29, 2020. REUTERS/Andrew Kelly

(Reuters] OysterPoint Pharma Inc., a drug development company, said Monday that its nasal spray for dry eyes disease treatment had been approved by the U.S. Food and Drug Administration.

Tyrvaya was announced by the company as a spray that will be available to prescription patients beginning next month.

This regulator made the decision based upon safety and effectiveness results of two late-stage and one mid-stage clinical trials that covered over 1000 patients suffering from dry eye disease (DED).

The chronic condition is affecting more than 30 million Americans. It causes stinging, light sensitivity, blurred vision, and eye fatigue.

Oyster Point reported March that data from all the trials indicated that Tyrvaya had statistically significantly improved tear film production on the eye surface.

Tear film is a way to protect your eyes from infection. It can also help to maintain clear vision.

In a statement, Ed Holland, Director of Corneal Services at Cincinnati Eye Institute and Professor of Ophthalmology at University of Cincinnati stated that the product provides “clinically meaningful” production of basal tears film in as little as 4 weeks.

Tyrvaya, a nasal spray of varenicline that is also available in a formulation called Tyrvaya, can be used to treat a variety of conditions. Pfizer Chantix, Inc’s anti-smoking drug Chantix (NYSE:), is available from Inc.

Tyrvaya stimulates the natural tear-film production and relieves dry eye symptoms.

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