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OC-01 FDA Approval Status

FDA Approved: No
Brand name: OC-01
Generic name: varenicline
Dosage form: Nasal Spray
Company: Oyster Point Pharma, Inc.
Treatment for: Dry Eye Disease

OC-01 (varenicline) is a nasal spray formulation of the highly selective cholinergic agonist varenicline in development for the treatment of the signs and symptoms of dry eye disease.

Administered as a preservative-free, aqueous nasal spray, in pre-clinical and clinical studies, varenicline nasal spray was shown to have a novel mechanism of action with activation of the trigeminal parasympathetic pathway in the nasal cavity to stimulate natural tear film production.

Development Timeline for OC-01

DateArticle
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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