Durysta (bimatoprost implant) is a prostaglandin analog.
Durysta is specifically indicted for the reduction of intraocular pressure (IOP) in patients with open angle glaucoma (OAG) or ocular hypertension (OHT).
Durysta is supplied as an implant for intracameral administration.
The FDA Approval of Durysta was 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 Durysta versus twice daily topical timolol drops, an FDA accepted comparator for registrational clinical trials, in patients with OAG or OHT. In the two Phase 3 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. Durysta demonstrated an IOP reduction of approximately 5-8 mmHg in patients with a mean baseline IOP of 24.5 mmHg.
Adverse effects associated with the use of Durysta may include, but are not limited to, the following:
Durysta (bimatoprost implant) is a prostaglandin analog. Bimatoprost is believed to lower IOP in humans by increasing outflow of aqueous humor through both the trabecular meshwork (conventional) and uveoscleral routes (unconventional). Elevated IOP presents a major risk factor for glaucomatous field loss. The higher the level of IOP, the greater the likelihood of optic nerve damage and visual field loss.
For additional information regarding Durysta or intraocular pressure (IOP) in patients with open angle glaucoma (OAG) or ocular hypertension, please visit the Durysta web page.