According to Oyster Point Pharma, the FDA has approved the company’s Tyrvaya (OC-01) varenicline nasal spray for the treatment of dry eye disease, and Oyster Point expects to launch the nasal spray in November 2021. Oyster Point submitted the 505(b)(2) NDA for OC-01 in December 2020 and announced that the FDA accepted the NDA in March 2021. The company had previously announced positive results from the Phase 3 ONSET-2 trial of OC-01 in May 2020.
Oyster Point Pharma President and CEO Jeffrey Nau commented, “The approval of Tyrvaya nasal spray marks a milestone for patients and eye care professionals by providing a new drug treatment option for the signs and symptoms of dry eye disease with a differentiated route of administration that is believed to leverage a nerve pathway that can be accessed within the nose. In any therapeutic area, it’s always an exciting moment when you follow the science and develop a truly innovative pharmaceutical treatment option for patients that addresses an important unmet medical need. In conjunction with the FDA, it has been an honor to work alongside my colleagues at Oyster Point to bring Tyrvaya nasal spray to the dry eye disease community. We look forward to making Tyrvaya nasal spray available to eye care professionals and their patients.”
The company is also developing OC-01 for the treatment of neurotrophic keratopathy and recently initiated a Phase 2 trial of the nasal spray in neurotrophic keratopathy patients.
Read the Oyster Point Pharma press release.
