Durysta has become the first and only intracameral, biodegradable sustained-release implant indicated to reduce intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) after Allergan’s New Drug Application (NDA) was accepted by the FDA.
The approval is based on results from the two 20-month (including 8-month extended follow up) Phase 3 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 3 ARTEMIS studies, Durysta 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.
“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 at Allergan.
He added: “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.”