The Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for OC-01 (varenicline; Oyster Point Pharma) nasal spray for the treatment of signs and symptoms of dry eye disease.

The investigational nasal spray contains varenicline, a highly selective nicotinic acetylcholine agonist, which is believed to stimulate natural tear film production by activating the trigeminal parasympathetic pathway in the nasal cavity. The NDA submission is supported by data from the phase 3 ONSET-2 (ClinicalTrials.gov: NCT04036292), phase 2b ONSET-1 (ClinicalTrials.gov: NCT03636061), and phase 2 MYSTIC trials that included over 1000 patients with mild, moderate or severe symptoms of dry eye disease.

Findings from these trials showed that treatment with OC-01 nasal spray demonstrated statistically significant improvements in Schirmer’s Score (a measure of natural tear film production) when compared with control. Additionally, in both the ONSET-1 and ONSET-2 trials, OC-01 nasal spray was associated with a statistically or nominally statistically significant improvement in eye dryness score at day 28, and in ONSET-2 as early as day 14, compared with control. The most common treatment-emergent adverse event reported was sneezing, which was transient and mild in severity.

A Prescription Drug User Fee Act (PDUFA) target date of October 17, 2021 has been set for this application. If approved, the Company plans to launch OC-01 nasal spray in the fourth quarter of 2021.


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Reference

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. [press release]. Princeton, NJ: Oyster Point Pharma, Inc.; March 2, 2021.