Frequently Asked Questions About DURYSTA

overview-icon DURYSTA Overview

Q:What is DURYSTA?

A: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). 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.

Q:How does DURYSTA work?

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.

Q:How large is the DURYSTA implant?

A:The DURYSTA implant is approximately 1 mm in length and is administered via a 28-gauge needle.2

Q:Does DURYSTA contain preservatives?

A:No. The DURYSTA intracameral implant is preservative-free.3

Q:Are there any special storage considerations for DURYSTA?

A:While in storage, DURYSTA should be refrigerated at 2°C to 8°C (36°F to 46°F).1

efficacy-icon Efficacy and Safety

Q:What is the IOP-lowering efficacy of DURYSTA?

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.

Q:What were the most common adverse reactions in clinical studies with DURYSTA?

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.

Q:Can DURYSTA be used in pediatric patients?

A:Safety and effectiveness of DURYSTA in pediatric patients have not been established.1

Q:Can DURYSTA be used in patients with narrow anterior chamber angles?

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.

Q:Does DURYSTA cause iris pigmentation?

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.

admin-icon Administration
admin-guide
For complete administration instructions, download the administration guide.

Q:How often is a new DURYSTA implant administered?

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.

Q:Can I administer DURYSTA to my patients in-office?

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.

Q:How do I know that I have achieved correct placement of the implant?

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.

Q:Can I administer DURYSTA to both eyes during the same visit?

A:DURYSTA was not administered in both eyes of any subject in the clinical studies.

Q:What is used to administer DURYSTA?

A:Each DURYSTA intracameral implant comes preloaded in a single-use applicator with a 28-gauge needle.1,2

access-icon Access and Support

Q:Is there a copay program offered for my DURYSTA patients?

A:Yes. Through the DURYSTA Patient Savings Program, eligible commercially insured patients may pay as little as $20 per implant. Learn more.

Q:Are training and support materials available for my staff?

A:Yes. We offer a variety of resources around injection training, access support, and reimbursement support for your practice. Learn more about office resources.

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

Contraindications

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.

Adverse Reactions

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.

IMPORTANT SAFETY INFORMATION AND INDICATIONS AND USAGE
COLLAPSE

Contraindications

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.

Adverse Reactions

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.

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).

Please see full Prescribing Information.