FDA accepts NDA for STN10117 for glaucoma, ocular hypertension
The FDA accepted a new drug application for STN10117 for the treatment of glaucoma and ocular hypertension, Santen and Ube Industries announced in a press release.
STN10117 (DE-117) (omidenepag isopropyl) is an investigational topical ophthalmic solution that offers a new mechanism of action, the release said.
STN10117 was launched in Japan in 2018 as Eybelis ophthalmic solution 0.002% and approved in South Korea in 2019.
The FDA set Nov. 19, 2021, as the PDUFA date.