DUBLIN — Allergan plc announced that the U.S. Food and Drug Administration has approved its New Drug Application for Durysta.
The drug is an eye implant designed to reduce intraocular pressure in patients with open-angle glaucoma or ocular hypertension. It’s described as a 10 microgram biodegradable sustained-release bimatoprost implant.
“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 for Allergan. “At Allergan, our mission is to contribute meaningful strategies that help preserve people’s vision, while ensuring that therapies are mindful of the realities of administration and compliance. As a commitment to the ongoing development of this innovation, Allergan has five ongoing Phase 3 studies with DURYSTA to support further potential FDA label enhancement and rest of the world approvals.”
The drug “has the potential to significantly shift the paradigm for treating glaucoma,” said Dr. Felipe Medeiros, Distinguished Professor of Ophthalmology and vice-chair for technology, director clinical research unit, Department of Ophthalmology, Duke University.
With the launch of Durysta, Allergan expands availability of Allergan EyeCue, a reimbursement service for eyecare professionals to facilitate patient benefit verification, savings program enrollment for eligible patients, and prior authorization assistance for Allergan Eye Care products.