The Food and Drug Administration (FDA) has approved Durysta (bimatoprost implant; Allergan) for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
Durysta is an ophthalmic drug delivery system for a single intracameral administration of a biodegradable implant. The system consists of a single-use applicator that contains bimatoprost, a prostaglandin analog. It is limited to a single implant per eye, and should not be readministered to an eye previously treated with Durysta.
The approval was based on data from 2 multicenter, randomized, parallel-group, controlled 20-month (including 8 month extended follow-up) studies of Durysta compared with twice daily topical timolol 0.5% drops, in patients with open-angle glaucoma or ocular hypertension. Durysta demonstrated an IOP reduction of approximately 5-8mmHg in patients with a mean baseline IOP of 24.5mmHg
With regard to safety, the most common ocular adverse reactions reported by 27% of patients was conjunctival hyperemia. Other common adverse reactions included foreign body sensation, eye pain, photophobia, conjunctival hemorrhage, dry eye, eye irritation, increased IOP, corneal endothelial cell loss, blurred vision, iritis, and headache.
“The ARTEMIS trials demonstrated that Durysta lowered IOP in patients by approximately 30% and demonstrated a duration of effect through the 12-week primary efficacy period,” said Felipe Medeiros, MD, PhD, Distinguished Professor of Ophthalmology and Vice-Chair for Technology, Director Clinical Research Unit, Department of Ophthalmology, Duke University. “As the first FDA-approved intracameral, biodegradable sustained-release implant providing continuous drug delivery, Durysta has the potential to significantly shift the paradigm for treating glaucoma.”
The product will be available as an intracameral implant containing bimatoprost 10mcg in a single-use applicator that is packaged in a sealed foil pouch.
For more information visit allergan.com.