Durysta, the first intracameral biodegradable sustained-release implant designed to lower IOP in patients with open-angle glaucoma or ocular hypertension, has been approved by the FDA, Allergan announced in a press release.
The approval is based on the results of the two 20-month phase 3 ARTEMIS studies, including an 8-month extended follow-up, that evaluated the efficacy and safety of Durysta (bimatoprost implant) 10 µg in 1,122 subjects. The treatment was compared with twice-daily topical timolol drops, an FDA-accepted comparator for registrational clinical trials, in patients with
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