Allergan wins approval for first glaucoma implant

Allergan receives approval for the first and only intracameral biodegradable sustained-release implant to lower intraocular pressure (IOP) in open-angle glaucoma (OAG) or ocular hypertension (OHT) patients.

“The 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, Allergan. “As a commitment to the ongoing development of this innovation, Allergan has five ongoing Phase III studies with DURYSTA (bimatoprost implant) to support further potential FDA label enhancement and rest of the world approvals.”

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The FDA approval is based on results from the two Phase III ARTEMIS studies evaluating 1,122 subjects on the efficacy and safety of DURYSTA versus twice daily topical timolol drops, an FDA accepted comparator for registrational clinical trials, in patients with OAG or OHT.

In the two Phase III ARTEMIS studies, DURYSTA – a prostaglandin analog – reduced IOP by approximately 30% from baseline over the 12-week primary efficacy period, meeting the predefined criteria for non-inferiority to the study comparator.

“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,” said Felipe Medeiros , M.D., Ph.D., 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.”

Glaucoma is the leading cause of irreversible blindness worldwide:

• Approximately 300,000 Australians have glaucoma
• 50% of people with glaucoma in Australia are undiagnosed
• Glaucoma can cause blindness if it is left untreated. Approximately 10% of people in Australia with glaucoma who receive proper treatment still experience significant vision loss

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