FDA clears bimatoprost implant for glaucoma 

April 4, 2020 0 By FM

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.