FDA OKs First Biodegradable Implant to Lower Intraocular Pre
The US Food and Drug Administration (FDA) has approved Allergan's bimatoprost implant (Durysta), the first intracameral biodegradable sustained-release implant designed to lower intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
Since, millions of people are living with glaucoma, one of the leading causes of vision loss; however, new treatment options are needed to help doctors and patients better manage this disease

The implant delivers 10 µg of bimatoprost, a prostaglandin analog. It comes in a preloaded, single-use applicator to facilitate the administration directly into the anterior chamber of the eye. Its use should be limited to a single implant per eye without retreatment.

The safety and efficacy of the bimatoprost implant were assessed in two phases 3 trials known as ARTEMIS that lasted for 20 months (including an 8-month extended follow-up) that enrolled 1122 patients with OAG or OHT. In both trials, the bimatoprost implant reduced IOP by about 30% from baseline over the 12-week primary efficacy period, meeting the predefined criteria for non-inferiority to the study comparator.

Caution should be used when prescribing bimatoprost implant in patients with limited corneal endothelial cell reserve; in patients with narrow iridocorneal angles (Shaffer grade < 3) or anatomical obstruction (scarring) that may prohibit settling in the inferior angle; in patients with known risk factors for macular edema; and in patients with active intraocular inflammation (uveitis) because the inflammation may be exacerbated.

Source: https://fdahealthnews.com/stories/512777999-allergan-plc-u-s-fda-accepts-allergan-s-new-drug-application-for-bimatoprost-sustained-release-in-patients-with-open-angle-glaucoma-or-ocular-hypertension
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