The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for bimatoprost sustained-release (SR; Allergan), a first-in-class biodegradable implant, for the reduction of intraocular pressure (IOP) in patients with primary open-angle glaucoma or ocular hypertension.
The NDA includes data from two phase 3 studies (NCT02250651, NCT02247804) that evaluated the efficacy and safety of bimatoprost SR vs timolol in patients (N=1122) with open-angle glaucoma or ocular hypertension. Patients were randomized to receive bimatoprost SR administered on Day 1, Week 16 and Week 32 or timolol twice a day for up to 20 months, as well as matching placebos. The primary end point was the change from baseline in IOP in the study eye at Weeks 2, 6, and 12.
Results showed that treatment with bimatoprost SR reduced IOP by 30% over 12 weeks, achieving non-inferiority to timolol. In addition, more than 80% of patients remained treatment free and maintained IOP control for at least 12 months following 3 treatments with bimatoprost SR; the implant was generally well tolerated.
“Data from the ARTEMIS trials show Bimatoprost SR lowers IOP and maintains that effect for the majority of patients for 1 year after 3 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,” said Robert Weinreb, MD, Chairman & Distinguished Professor of Ophthalmology and Director of the Shiley Eye Institute, San Diego.
Bimatoprost, a prostaglandin analogue, is believed to lower IOP by increasing outflow of aqueous humor through both the trabecular meshwork and uveoscleral routes. It is currently available as a once-daily ophthalmic solution (Lumigan; Allergan) for the reduction of elevated IOP in open-angle glaucoma or ocular hypertension.
The FDA is expected to take action on the bimatoprost SR application by the end of the first half of 2020.
For more information visit allergan.com.