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Tyrvaya FDA Approval History

Last updated by Judith Stewart, BPharm on Nov 4, 2021.

FDA Approved: Yes (First approved October 15, 2021)
Brand name: Tyrvaya
Generic name: varenicline
Dosage form: Nasal Spray
Company: Oyster Point Pharma, Inc.
Treatment for: Dry Eye Disease

Tyrvaya (varenicline) is a nasally administered selective cholinergic agonist for the treatment of the signs and symptoms of dry eye disease.

  • Dry eye disease is a multifactorial disease of the ocular surface characterized by disruption of the tear film. Tyrvaya is thought to work by binding to the cholinergic receptors to activate the trigeminal parasympathetic pathway in the nasal cavity to stimulate natural tear film production.
  • Varenicline was first approved in an oral formulation under the brand name Chantix as a treatment for smoking cessation.
  • Tyrvaya is administered as one spray in each nostril twice daily (approximately 12 hours apart).
  • Common adverse reactions include sneezing, cough, throat irritation, and nose irritation.

 

Development timeline for Tyrvaya

DateArticle
Oct 18, 2021Approval FDA Approves Tyrvaya (varenicline solution) Nasal Spray for the Treatment of the Signs and Symptoms of Dry Eye Disease
Mar  2, 2021Oyster Point Pharma Announces FDA Acceptance for Filing New Drug Application for OC-01 (varenicline) Nasal Spray for the Treatment of Signs and Symptoms of Dry Eye Disease
Dec 18, 2020Oyster Point Pharma Submits New Drug Application to the U.S. Food and Drug Administration for OC-01 (varenicline) Nasal Spray for the Treatment of Signs and Symptoms of Dry Eye Disease

Further information

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