Posted by Michael Wonder on 17 Jul 2019
U.S. FDA accepts Allergan's new drug application for bimatoprost sustained release in patients with open-angle glaucoma or ocular hypertension
17 July 2019 - Filing included data from the Phase 3 ARTEMIS studies, which demonstrated that the majority of patients remained treatment free for at least 1 year following 3 treatments with bimatoprost sustained release.
Allergan today announced that the U.S. FDA has accepted the company's new drug application for bimatoprost sustained release (SR). Bimatoprost SR if approved would be the first-in-class sustained-release, biodegradable implant for the reduction of intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension.
The FDA is expected to take action on the application by the end of the first half of 2020.
