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The FDA has accepted Oyster Point Pharma's New Drug Application (NDA) for its OC-01 (varenicline) nasal spray to treat dry eye disease.
Oyster Point Pharma, Inc. announced today that the U.S. FDA accepted its New Drug Application (NDA) for its OC-01 (varenicline) nasal spray to treat dry eye disease (DED).
The OC-01 nasal spray is a highly selective cholinergic agonist that is administered as a preservative-free, aqueous nasal spray taken in multiple doses. It targets the parasympathetic nervous system that controls tear film homeostasis partially by way of the trigeminal nerve — accessible within the nose.1
The company’s latest submission follows safety and efficacy results from its Phase 3 ONSET-2, Phase 2b ONSET-1, and Phase 2 MYSTIC clinical trials, according to the news release. The trials included more than 1,000 participants with mild, moderate, or severe symptoms of DED.
Results showed OC-01 nasal spray demonstrated statistically significant improvements, as compared to control, in Schirmer’s Score, which was the primary endpoint in all trials, according to the release. Further, key secondary endpoints in the ONSET-1 and ONSET-2 included a shift from baseline in symptoms as assessed by eye dryness score.
In both trials, a statistically or nominally statically significant improvement in symptom scores at Day 28, and in the ONSET-2 trial as early as Day 14, in patients treated with the OC-01 nasal spray as compared to control, the release stated.
No serious drug-related events were reported in the clinical trial program.
The company’s Prescription Drug User Fee Act (PDUFA) target action for the nasal spray is October 17, 2021, according to a news release. At present, the FDA is not planning on holding an advisory committee meeting regarding the application.
1. Oyster Point Pharma. Pipeline: OC-01. Available at: https://oysterpointrx.com/pipeline/oc-01/. Accessed 3/02/2021.
2. Oyster 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. Global News Wire. Available at: https://www.globenewswire.com/news-release/2021/03/02/2185010/0/en/Oyster-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.html. Accessed 3/02/2021.