According to Oyster Point Pharma, the FDA has accepted the company’s NDA for its OC-01 varenicline nasal spray for the treatment of dry eye disease and has set a PDUFA goal date of October 17, 2021. The company said that the FDA has no plans for an advisory committee meeting in regards to the application.
Oyster Point submitted the 505(b)(2) NDA in December 2020. The application is supported by data from the the Phase 3 ONSET-2 trial, the Phase 2b ONSET-1 trial, and the Phase 2 MYSTIC trial.
Oyster Point Pharma President and CEO Jeffrey Nau commented, “The FDA acceptance of our NDA for OC-01 varenicline nasal spray represents a major milestone towards our goal of bringing novel and potentially transformational therapies to patients with ocular surface diseases. We look forward to continued interaction with the FDA during the review.”
Read the Oyster Point Pharma press release.
