The FDA has accepted a new drug application from Oyster Point Pharma for OC-01, a nasal spray treatment for the signs and symptoms of dry eye disease, according to a press release.
The submission for OC-01 (varenicline) is supported by positive safety and efficacy data from the phase 3 ONSET-2, the phase 2b ONSET-1 and the phase 2 MYSTIC clinical trials, in which more than 1,000 patients with dry eye disease demonstrated significantly significant improvement in Schirmer’s score compared with control, the release said. Secondary endpoints in the ONSET trials (Read more...)
Uncategorized