Oyster Point Pharma has announced its submission of a 505(b)(2) NDA for its OC-01 varenicline nasal spray for the treatment of dry eye disease. In May 2020, Oyster Point announced positive results from the the Phase 3 ONSET-2 trial. The company says that data from the Phase 2b ONSET-1, and Phase 2 MYSTIC trials are also used to support the NDA submission.
Oyster Point Pharma President and CEO Jeffrey Nau commented, “The submission of Oyster Point’s first NDA is a major step towards our goal of bringing novel and transformative therapies to patients with ocular surface diseases. We have intently focused on the advancement of OC-01 nasal spray from formulation through clinical development and regulatory submission over the last three years. We look forward to continued interaction with the FDA during the review process.”
Chief Medical Officer Marian Macsai said, “We are excited by the potential of OC-01 nasal spray, if approved, becoming a meaningful addition to the eye care practitioner’s treatment armamentarium, and the potential to create a paradigm shift in how practitioners and their patients treat dry eye disease.”
Read the Oyster Point Pharma press release.
