OYST - FDA accepts Oyster Point Pharma's varenicline nasal spray application

The FDA has accepted Oyster Point Pharma's (OYST) New Drug Application ((NDA)) for OC-01 (varenicline) nasal spray for the treatment of signs and symptoms of dry eye disease.The PDUFA target action date is October 17.At present, FDA has stated that it does not intend to hold an advisory committee meeting to discuss this application. The NDA submission was supported by safety and efficacy results from the Phase 3 ONSET-2, Phase 2b ONSET-1, and Phase 2 MYSTIC clinical trials.

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FDA accepts Oyster Point Pharma's varenicline nasal spray application