DURYSTA™ (bimatoprost implant) is a prostaglandin analog indicated for the reduction of intraocular pressure (IOP) in patients with open angle glaucoma (OAG) or ocular hypertension (OHT).2
DURYSTA™ is a sterile intracameral implant containing 10 mcg of bimatoprost, a prostaglandin analog, in a solid polymer sustained-release drug delivery system (DDS). Bimatoprost is believed to lower IOP in humans by increasing outflow of aqueous humor through both the trabecular meshwork (conventional) and uveoscleral routes (unconventional). DURYSTA™ is preloaded into a single-use, DDS applicator to facilitate injection of the rod-shaped implant directly into the anterior chamber of the eye.2 Learn more
DURYSTA™ is an ophthalmic DDS for a single intracameral administration of a biodegradable implant containing 10 mcg of bimatoprost.
DURYSTA™ should not be readministered to an eye that received a prior DURYSTA™ implant.2
DURYSTA™ contains a 10 mcg implant in a single-use applicator that is packaged in a sealed foil pouch containing desiccant, NDC 0023-9652-01. Store refrigerated at 2°C to 8°C (36°F to 46°F).2
DURYSTA™ efficacy was evaluated in two, 20-month (including 8-month extended follow-up), multicenter, randomized, parallel-group, controlled clinical studies2:
DURYSTA™ demonstrated an IOP reduction of approximately 5-8 mmHg in patients with a mean baseline IOP of 24.5 mmHg.2 To see full efficacy data, Learn more
The most common ocular adverse reaction observed in 2 randomized, active-controlled clinical trials with DURYSTA™ in patients with OAG or OHT was conjunctival hyperemia, which was reported in 27% of patients.2
Other common ocular adverse reactions reported in 5% to 10% of patients were2:
The most common nonocular adverse reaction was headache, which was observed in 5% of patients.2 Learn more
There are no adequate and well-controlled studies of DURYSTA™ (bimatoprost implant) administration in pregnant women to inform a drug associated risk.2 Learn more
There is no information regarding the presence of bimatoprost in human milk, the effects on the breastfed infants, or the effects on milk production. In animal studies, topical bimatoprost has been shown to be excreted in breast milk. Because many drugs are excreted in human milk, caution should be exercised when DURYSTA™ is administered to a nursing woman.2
The developmental and health benefits of breastfeeding should be considered, along with the mother’s clinical need for DURYSTA™ and any potential adverse effects on the breastfed child from DURYSTA™.2
Safety and effectiveness of DURYSTA™ in pediatric patients have not been established.2
No overall differences in safety or effectiveness have been observed between elderly and other adult patients.2
Following administration with DURYSTA™, the intracameral implant is intended to settle within the inferior angle. DURYSTA™ should be used with caution in patients with narrow iridocorneal angles (Shaffer grade < 3) or anatomical obstruction (eg, scarring) that may prohibit settling in the inferior angle.2
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. The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. While treatment with DURYSTA™ can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly.2
Iris hyperpigmentation occurred in 1-5% of patients observed in 2 randomized, active-controlled clinical trials of DURYSTA™ in patients with OAG or OHT.2
The intracameral injection procedure must be performed under magnification that allows clear visualization of the anterior chamber structures and should be carried out using standard aseptic conditions for intracameral procedures, with the patient’s head in a stabilized position. The eye should not be dilated prior to the procedure.2 For complete administration instructions, please consult the full Prescribing Information and see the administration guide for further details. Learn more
DURYSTA™ should not be readministered to an eye that received a prior DURYSTA™.2
Treatment-related effects: Advise patients about the potential risk for complications including, but not limited to, the development of corneal adverse events, intraocular inflammation, or endophthalmitis.2 Learn more
Potential for pigmentation: Advise patients about the potential for increased brown pigmentation of the iris, which may be permanent.2 Learn more
When to seek physician advice: Advise patients that if the eye becomes red, sensitive to light, painful, or develops a change in vision, they should seek immediate care from an ophthalmologist.2 Learn more
Yes, through Allergan EyeCue®—a convenient and efficient way to address your DURYSTA™ reimbursement questions. Learn more
Yes, we offer a variety of resources around administration training. Learn more
DURYSTA™ (bimatoprost implant) is indicated for the reduction of intraocular pressure (IOP) in patients with open angle glaucoma (OAG) or ocular hypertension (OHT).
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.
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.
References: 1. Allergan receives FDA approval for DURYSTA™ (bimatoprost implant) the first and only intracameral biodegradable sustained-release implant to lower intraocular pressure in open-angle glaucoma or ocular hypertension patients [press release]. Dublin: PR Newswire; March 5, 2020. 2. DURYSTA™ [Prescribing Information]. Irvine, CA: Allergan, Inc.; 2020.