FDA accepts filing of NDA application for bimatoprost sustained-release for reduction of intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension. Allergan/Abbvie

Allergan plc, has announced that the FDA has accepted the company's New Drug Application (NDA) 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 NDA by the end of the first half of 2020.

The NDA is based on the positive results from the ARTEMIS Phase III studies.In the two Phase III ARTEMIS studies, Bimatoprost SR reduced intraocular pressure (IOP) by 30 percent over the 12-week primary efficacy period, meeting the predefined criteria for non-inferiority to the study comparator. The ARTEMIS studies evaluated 1,122 subjects on the efficacy and safety of Bimatoprost SR versus timolol, a FDA standard comparator for registrational clinical trials, in patients with open-angle glaucoma or ocular hypertension. After three treatments with Bimatoprost SR, greater than 80 percent of patients remained treatment free and did not need additional treatment to maintain IOP control for at least 12 months. Bimatoprost SR was well tolerated in the majority of patients.