Oyster Point Pharma, a clinical-stage biopharma focused on treating ocular surface diseases, announced positive results of a Phase 3 study testing a reformulation of the smoking-cessation drug Chantix as a nasal spray treatment for dry eye.
According to the NJ-based company, the ONSET-2 trial met the primary endpoint, where a greater percentage of subjects treated with 0.6 mg/ml and 1.2 mg/ml of OC-01 nasal spray gained >10 mm on Schirmer’s score — a measure of tear film production — compared to control. Key secondary endpoints were met, including an improvement in eye dryness score in the normal clinic environment as well as mean change in Schirmer’s score in the 1.2 mg/ml dose group.
In 2006, the FDA approved approved varenicline tartrate tablets, marketed as Chantix by Pfizer, for use as an aid to smoking cessation treatment.
Oyster Point says it plans to submit its New Drug Application for OC-01 to the FDA in the second half of 2020. If approved, the drug will launch in the fourth quarter of 2021.
Read the press release