FDA approves DURYSTA™ (bimatoprost implant) New Drug Application

The US Food and Drug Administration (FDA) have approved Allergan plc’s New Drug Application (NDA) for DURYSTA™ (bimatoprost implant), the first intracameral, sustained-release implant indicated to reduce intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).

The approval is based on results from two Phase III ARTEMIS trials, comparing DURYSTA to timolol eye drops in patients with OAG or OHT. The studies evaluated 1,122 subjects over a course of 20 months and DURYSTA was shown to reduce IOP by 30 percent over the 12-week primary efficacy period, confirming it was non-inferior to timolol.

DURYSTA is an ophthalmic drug delivery system that is implanted into the anterior chamber of the eye. It delivers sustained-release of bimatoprost, a prostaglandin analogue which can reduce IOP. DURYSTA can only be implanted once into each eye and can cause adverse corneal effects, according to Allergan.

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