Trial Profile
Randomized, Controlled, Single-Masked Clinical Trial to Evaluate the Chronic Efficacy of OC-01 Nasal Spray on Signs of Dry Eye Disease (The MYSTIC Study)
Status:
Completed
Phase of Trial:
Phase II
Latest Information Update: 20 Jun 2022
Price :
$35
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At a glance
- Drugs Varenicline (Primary)
- Indications Dry eyes
- Focus Registrational; Therapeutic Use
- Acronyms MYSTIC
- Sponsors Oyster Point Pharmaceuticals
- 15 Jun 2022 According to an Oyster Point Pharmaceuticals media release, data from ONSET-1, ONSET-2, and MYSTIC trials will be presented at the American Optometric Association's Optometry's Meeting.
- 18 Oct 2021 According to an Oyster Point Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has approved TYRVAYA (varenicline solution) Nasal Spray 0.03 mg for the treatment of the signs and symptoms of dry eye disease based on results from the Phase 3 ONSET-2, Phase 2b ONSET-1, and Phase 2 MYSTIC clinical trials.
- 02 Mar 2021 According to an Oyster Point Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for OC-01 (varenicline) nasal spray for the treatment of signs and symptoms of dry eye disease. The Prescription Drug User Fee Act (PDUFA) target action date is October 17, 2021. FDA has stated that at present, it does not intend to hold an advisory committee meeting to discuss this application.