FDA Approves Biodegradable Sustained-release Implant to Lower IOP
The US Food and Drug Administration approved Durysta (bimatoprost implant), the first intracameral, biodegradable sustained-release implant indicated to reduce intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
Approval was based on results from two 20-month (including 8-month extended follow up) Phase 3 studies evaluating 1122 subjects on efficacy and safety versus twice daily topical timolol drops, an FDA accepted comparator for registrational clinical trials, in patients with OAG or OHT. Durysta was found to reduce 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, Allergan in a press release. “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.”
Read the full press release here.
Grandin Library Building
Six Leigh Street
Clinton, New Jersey 08809