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# FDA Accepts Oyster Point Pharma Dry Eye NDA
- URL: https://www.fdaweb.com/fda-accepts-oyster-point-pharma-dry-eye-nda/
- Published: 2021-03-02T12:00:00.000Z
- Updated: 2026-09-14T16:48:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148783

FDA has accepted an Oyster Point Pharma NDA for its OC-01 (varenicline) nasal spray to treat the signs and symptoms of dry eye disease. The agency assigned a PDUFA target action date of 10/17, the company [says](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?ref=fdaweb.com). It also says FDA currently does not plan to schedule an advisory committee meeting on the NDA.

Oyster Point says the submission was supported by safety and efficacy results from the Phase 3 ONSET-2, Phase 2b ONSET-1, and Phase 3 MYSTIC clinical trials in over 1,000 subjects with mild, moderate, or severe symptoms of dry eye disease. It says that in the trials OC-01 nasal spray demonstrated statistically significant improvements compared to control.