Posted by Michael Wonder on 21 Dec 2020
Oyster Point Pharma submits new drug application to the U.S. FDA for OC-01 (varenicline) nasal spray for the treatment of signs and symptoms of dry eye disease
18 December 2020 - The new drug application submission is based on efficacy and safety results from a comprehensive clinical trial program conducted in patients with a broad range of dry eye disease.
Oyster Point Pharma today announced it has submitted a 505(b)(2) new drug application to the U.S. FDA for 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 with dry eye disease.
