DURYSTA® Overview
A:DURYSTA® (bimatoprost intracameral implant) is a prostaglandin analog indicated for the reduction of intraocular pressure (IOP) in patients with open angle glaucoma (OAG) or ocular hypertension (OHT). DURYSTA® is an intracameral implant that contains 10 mcg of bimatoprost within a solid polymer matrix. The implant slowly biodegrades over time. Treatment with DURYSTA® is limited to a single administration per eye.1,2 Learn more.
A:DURYSTA® is believed to lower IOP by increasing outflow of aqueous humor through both the trabecular meshwork (conventional) and uveoscleral (unconventional) routes.1 Learn more about the MOA.
A:The DURYSTA® implant is approximately 1 mm in length and is administered via a 28-gauge needle.2
A:No. The DURYSTA® intracameral implant is preservative-free.3
A:While in storage, DURYSTA® should be refrigerated at 2°C to 8°C (36°F to 46°F).1
Efficacy and Safety
A:DURYSTA® was compared to twice-daily, topical timolol (0.5%) drops in 2 clinical studies. DURYSTA® demonstrated an IOP reduction of approximately 5-8 mmHg (up to a 33% reduction) in patients with a mean baseline IOP of 24.5 mmHg.1 Learn more about the full efficacy.
A:In Phase 3 clinical studies, the most common adverse reaction was conjunctival hyperemia, which occurred in 27% of patients. 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.1 Learn more about the safety profile.
A:Safety and effectiveness of DURYSTA® in pediatric patients have not been established.1
A: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.1 Learn more about administration and safety.
A:Ophthalmic bimatoprost, including DURYSTA®, 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. In clinical trials, iris hyperpigmentation occurred in 1-5% of patients.1 Learn more about the safety profile.
Administration
A:DURYSTA® is an ophthalmic drug delivery system for a single intracameral administration of a biodegradable implant. DURYSTA® should not be readministered to an eye that received a prior DURYSTA®.1 Learn more about administration.
A:In the Phase 3 clinical trials, DURYSTA® was administered while patients were in the supine position. The 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.1 See the administration guide for complete administration instructions.
A:Following administration, the patient should remain upright for at least 1 hour after the procedure so the implant can settle. The implant typically settles into place in the inferior aspect of the anterior chamber at or near the 6 o’clock position once the patient is sitting upright.1 Read more about correct administration.
A:DURYSTA® was not administered in both eyes of any subject in the clinical studies.
A:Each DURYSTA® intracameral implant comes preloaded in a single-use applicator with a 28-gauge needle.1,2
Access and Support
A:Yes. The DURYSTA® Savings Program—eligible commercially-insured patients pay $0* for up to one implant per eye. Learn more.
Offer valid only for commercially-insured patients with plans covering DURYSTA®; patient out-of-pocket expense may vary. Offer not valid for patients receiving reimbursement from Medicare, Medicaid, or any other federal, state, or government-funded healthcare program. See Program Terms, Conditions, and Eligibility Criteria here or visit www.durystasavingsprogram.com.
A:Yes. We offer a variety of resources around injection training, access support, and reimbursement support for your practice. Learn more about office resources.
DURYSTA® (bimatoprost intracameral 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. DURYSTA® [Prescribing Information]. Irvine, CA: Allergan, Inc.; 2020. 2. Data on file, Allergan, 2020. 3. DURYSTA® NDA FDA Approval Letter. March 4, 2020.
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.
DURYSTA® (bimatoprost intracameral implant) is indicated for the reduction of intraocular pressure (IOP) in patients with open angle glaucoma (OAG) or ocular hypertension (OHT).
Please see full Prescribing Information.
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US-DUR-210605 11/22
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