With approval, the new implant becomes the first approved for lowering IOP in patients with open-angle glaucoma and ocular hypertension.
Bimatoprost implant 10 mcg (Durysta(TM), an ophthalmic drug delivery system for a single intracameral administration, has received approval from the US Food and Drug Administration (FDA) for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
The approval of the bimatoprost implant, which was based on the results of 2 phase 3 trials involving more than 1,000 patients, makes the therapy the first intracameral, biodegradable sustain-release implant approved to lower IOP in patients with open-angle glaucoma or ocular hypertension, according to a statement from Allergan.
"Today's FDA approval marks a breakthrough milestone for the glaucoma community and provides a much-needed option for patients challenged with topical drops or needing alternative options," said David Nicholson, chief research and development officer with Allergan, in the aforementioned statement.
According to Allergan, the bimatoprost implant is administered using a preloaded single-use applicator to facilitate the administration of the implant into the anterior chamber of the eye. The company noted the therapy should not be re-administered to an eye that has previously received it.
Both of the phase 3 ARTEMIS studies used to support the approval of the ophthalmic therapy lasted 20 months and compared the therapy against twice daily topical timolol drops. Results of the trials indicated use could lower IOP by approximately 30% over the course of 12 weeks.
The therapy is contraindicated in patients with active or suspected ocular or periocular infections, corneal endothelial cell dystrophy, prior corneal transplantation or endothelial cell transplants, absent or ruptured posterior lens capsule, or hypersensitivity to bimatoprost or any of the other components of the therapy.
“As the first FDA-approved intracameral, biodegradable sustained-release implant providing continuous drug delivery, (Bimatoprost implant 10 mcg) has the potential to significantly shift the paradigm for treating glaucoma," said Felipe Medeiros, MD, PhD, distinguished professor of Ophthalmology and director of the clinical research unit, in the Department of Ophthalmology at Duke University, in the statement from Allergan.