■ Allergan said the FDA has accepted the company’s new drug application (NDA) for its sustained-release implant Bimatoprost SR. Bimatoprost SR, if approved, would be the first-in-class sustained-release, biodegradable implant for the reduction of intraocular pressure (IOP) in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHTN). The FDA is expected to take action on the NDA by the end of the first half of 2020.
In the 2 positive phase 3 ARTEMIS studies that led to the filing of the NDA, Bimatoprost SR reduced IOP by 30% over the 12-week primary efficacy period, meeting the predefined criteria for noninferiority to the study comparator. The ARTEMIS studies evaluated 1,122 subjects on the efficacy and safety of Bimatoprost SR vs timolol, an FDA standard comparator for registrational clinical trials, in patients with open-angle glaucoma or OHTN. After 3 treatments with Bimatoprost SR, 83% 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.
“Bimatoprost SR has the potential to be the first sustained-release option that could significantly shift the paradigm for treating glaucoma,” said Robert Weinreb, MD, chair, distinguished professor of ophthalmology, and director of the Shiley Eye Institute in San Diego, California.