FDA clears bimatoprost implant for glaucomaApril 4, 2020
The US FDA has approved bimatoprost implant (Durysta) 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), Allergan plc said.
The FDA 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 the implant versus twice-daily topical timolol drops in patients with OAG or OHT.
In the two-phase 3 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.