U.S. FDA Accepts Allergan’s New Drug Application

Allergan plc (NYSE: AGN), a leading global pharmaceutical company with more than 70 years of heritage in eye care, today announced that the U.S. Food and Drug Administration (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.

“With decades of experience researching and introducing innovative eye care treatments, we understand the importance of developing new and potentially sight-saving treatments for patients with glaucoma,” said David Nicholson, Chief Research and Development Officer, Allergan. “The NDA is based on the positive results from the ARTEMIS Phase 3 studies and demonstrates our ongoing commitment to providing new treatments for patients living with glaucoma.”

In the two Phase 3 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 3 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.

“Millions of people are living with glaucoma, a progressive disease that requires sustained IOP control to preserve vision for patients,” said Robert Weinreb, M.D., Chairman & Distinguished Professor of Ophthalmology and Director of the Shiley Eye Institute, San Diego. “Data from the ARTEMIS trials show Bimatoprost SR lowers IOP and maintains that effect for the majority of patients for one year after three administrations of the implant. Bimatoprost SR has the potential to be the first sustained-release option that could significantly shift the paradigm for treating glaucoma, a leading cause of blindness.” – PR Newswire