FDA approves Durysta to treat open-angle glaucoma or ocular hypertension .- Allergan

Allergan plc announced that the FDA has approved the company's New Drug Application (NDA) for Durysta (bimatoprost implant) 10 mcg for intracameral administration. With this approval, Durysta becomes the first intracameral, biodegradable sustained-release implant indicated to reduce intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). The FDA approval is based on results from the two 20-month (including 8-month extended follow up) 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 (open-angle glaucoma) or OHT(ocular hypertension ). In the two Phase III ARTEMIS studies, Durysta reduced IOP by approximately 30 percent from baseline over the 12-week primary efficacy period, meeting the predefined criteria for non-inferiority to the study comparator.