INDICATIONS AND USAGE
DURYSTA™ (bimatoprost implant) is indicated for the reduction of intraocular
pressure (IOP) in patients with open angle glaucoma (OAG) or ocular hypertension (OHT).
IMPORTANT SAFETY INFORMATION
DURYSTA™ is contraindicated in patients with: active or suspected ocular or
periocular infections; corneal endothelial cell dystrophy (e.g., Fuchs’ Dystrophy);
prior corneal transplantation or endothelial cell transplants (e.g., 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.
Warnings and Precautions
The presence of DURYSTA™ implants has been associated with corneal adverse
reactions and increased risk of corneal endothelial cell loss. Administration of
DURYSTA™ should be limited to a single implant per eye without retreatment.
Caution should be used when prescribing DURYSTA™ in patients with limited
corneal endothelial cell reserve.
DURYSTA™ should be used with caution in patients with narrow iridocorneal
angles (Shaffer grade < 3) or anatomical obstruction (e.g., scarring) that may
prohibit settling in the inferior angle.
Macular edema, including cystoid macular edema, has been reported during treatment
with ophthalmic bimatoprost, including DURYSTA™ intracameral implant. DURYSTA™ should be used
with caution in aphakic patients, in pseudophakic
patients with a torn posterior lens capsule, or in patients with known risk factors
for macular edema.
Prostaglandin analogs, including DURYSTA™, have been reported to cause
intraocular inflammation. DURYSTA™ should be used with caution in
patients with active intraocular inflammation (e.g., uveitis) because the
inflammation may be exacerbated.
Ophthalmic bimatoprost, including DURYSTA™ intracameral implant, has been
reported to cause changes to pigmented tissues, such as increased pigmentation of
the iris. Pigmentation of the iris is likely to be permanent. Patients who receive
treatment should be informed of the possibility of increased pigmentation. While
treatment with DURYSTA™ can be continued in patients who develop
noticeably increased iris pigmentation, these patients should be examined regularly.
Intraocular surgical procedures and injections have been associated with
endophthalmitis. Proper aseptic technique must always be used with administering
DURYSTA™, and patients should be monitored following the administration.
In controlled studies, the most common ocular adverse reaction reported by 27% of
patients was conjunctival hyperemia. Other common adverse reactions reported in
5%-10% of patients were foreign body sensation, eye pain, photophobia, conjunctival
hemorrhage, dry eye, eye irritation, intraocular pressure increased, corneal
endothelial cell loss, vision blurred, iritis, and headache.
Please see full Prescribing Information.