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).
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 was assessed in two phase 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. It was compared against twice daily topical timolol drops, an FDA-accepted comparator, according to a company news release.
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.
The common ocular adverse reaction reported by 27% of patients was conjunctival hyperemia. Other common adverse reactions reported in 5% to 10% of patients were foreign body sensation, eye pain, photophobia, conjunctival hemorrhage, dry eye, eye irritation, intraocular pressure increase, corneal endothelial cell loss, blurred vision, iritis, and headache.
"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," Felipe Medeiros, MD, PhD, distinguished professor of ophthalmology, Duke University, Durham, North Carolina, said in the news release.
"As the first FDA-approved intracameral, biodegradable, sustained-release implant providing continuous drug delivery, Durysta has the potential to significantly shift the paradigm for treating glaucoma," he said.
Bimatoprost implant is contraindicated in patients with active or suspected ocular or periocular infections; corneal endothelial cell dystrophy (Fuchs' Dystrophy); prior corneal transplantation or endothelial cell transplants (Descemet's Stripping Automated Endothelial Keratoplasty [DSAEK]); absent or ruptured posterior lens capsule, due to the risk of implant migration into the posterior segment; hypersensitivity to bimatoprost or to any other components of the product.
Bimatoprost implant has been associated with corneal adverse reactions and increased risk of corneal endothelial cell loss.
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.
Complete prescribing information is available online.
Cite this: Megan Brooks. FDA OKs First Biodegradable Implant to Lower Intraocular Pressure - Medscape - Mar 05, 2020.