Biodegradable Durysta approved to lower IOP
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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 open-angle glaucoma or ocular hypertension.
In both studies, Durysta reduced IOP by approximately 30% from baseline over the 12-week primary efficacy period, which met the predefined criteria for noninferiority to the study comparator, according to the release.
In controlled studies, the most common ocular adverse reaction was conjunctival hyperemia in 27% of patients.