- Oyster Point Pharma (NASDAQ:OYST) has submitted a marketing application to the FDA seeking approval for its lead candidate, OC-01 (varenicline) nasal spray for the treatment of signs and symptoms of dry eye disease.
- The submission is supported by safety and efficacy results from the Phase 3 ONSET-2, Phase 2b ONSET-1, and Phase 2 MYSTIC clinical trials in over 1,000 subjects.
- OC-01 is a highly selective cholinergic agonist being developed as a multidose preservative-free nasal spray.