Allergan has secured the US Food and Drug Administration (FDA) approval for its New Drug Application (NDA) for DURYSTA (bimatoprost implant) 10mcg for intracameral administration.
The Irish pharmaceutical firm said that its DURYSTA is a biodegradable sustained-release implant indicated for reducing intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
Allergan chief research and development officer David Nicholson said: “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.
“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.”
DURYSTA has reduced around 30% IOP in two Phase 3 ARTEMIS clinical trials
The FDA approval was supported by results from two Phase 3 ARTEMIS studies, evaluating the efficacy and safety of DURYSTA, compared to twice-daily topical timolol drops, in 1,122 subjects. Topical timolol drops is an FDA accepted comparator for registrational clinical trials, in patients with OAG or OHT.
The two Phase 3 ARTEMIS studies demonstrated that DURYSTA has reduced IOP by approximately 30% from baseline, satisfying the predefined criteria for non-inferiority to the study comparator.
Allergan said that the launch of DURYSTA will expand the availability of its Allergan EyeCue, a reimbursement service for eye care professionals, which facilitates prior authorization (PA) assistance for Allergan Eye Care products.
Duke University department of ophthalmology clinical research unit director Felipe Medeiros said: “Millions of people are living with glaucoma, one of the leading causes of vision loss; however, new treatment options are needed to help doctors and patients better manage this disease.
“The ARTEMIS trials demonstrated that DURYSTA lowered IOP in patients by approximately 30 percent and demonstrated a duration of effect through the 12-week primary efficacy period.
“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.”