FDA accepts new drug application for OC-01 nasal spray for DED
Oyster Point Pharma, Inc announced that the U.S. Food and Drug Administration has accepted its new drug application for OC-01 (varenicline) nasal spray for the treatment of signs and symptoms of dry eye disease. The Prescription Drug User Fee Act target action date is October 17, 2021.
The submission was supported from the results of the Phase 3 ONSET-2, Phase 2b ONSET-1, and Phase 2 MYSTIC clinical trials which found the nasal spray demonstrated statistically significant improvements in Schirmer’s Score compared to control. in patients treated with OC-01 nasal spray n ONSET-1 and ONSET-2, there was statistically or nominally statistically significant improvement in eye dryness score at day 28 and in ONSET-2 as early as day 14, compared to control.
All doses studied in the clinical trial program were well-tolerated with no serious drug-related adverse events.
“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,” said Jeffrey Nau, PhD, MMS, president and CEO of Oyster Point Pharma in a press release. “We look forward to continued interaction with the FDA during the review.”
Read the full press release here.