FREQUENTLY ASKED QUESTIONS

General Information About DURYSTA

What is DURYSTA indicated for?

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

What is the mechanism of action of DURYSTA?

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

What is the dosage form of DURYSTA and how often should it be dosed?

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

How is DURYSTA supplied and stored?

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

Efficacy FAQs

How was DURYSTA efficacy studied?

DURYSTA efficacy was evaluated in two, 20-month (including 8-month extended follow-up), multicenter, randomized, parallel-group, controlled clinical studies2:

  • DURYSTA was compared to twice-daily topical timolol 0.5% drops, in patients with OAG or OHT
  • DURYSTA demonstrated an IOP reduction of approximately 5-8 mmHg in patients with a mean baseline IOP of 24.5 mmHg. To see full efficacy data, Learn more

What is the IOP-lowering effect of DURYSTA?

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

Safety FAQs

What are the most common adverse reactions with DURYSTA?

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:

  • Foreign body sensation
  • Eye pain
  • Photophobia
  • Conjunctival hemorrhage
  • Dry eye
  • Eye irritation
  • Intraocular pressure increased
  • Corneal endothelial cell loss
  • Vision blurred
  • Iritis

The most common nonocular adverse reaction was headache, which was observed in 5% of patients.2 Learn more

Can DURYSTA be used in pregnant patients?

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

Can DURYSTA be used in lactating patients?

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

Can DURYSTA be used in pediatric patients?

Safety and effectiveness of DURYSTA in pediatric patients have not been established.2

Can DURYSTA be used in geriatric patients?

No overall differences in safety or effectiveness have been observed between elderly and other adult patients.2

Can DURYSTA be used in patients with narrow anterior angles?

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

Can DURYSTA cause iris pigmentation?

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

Administration FAQs

In what conditions must the DURYSTA implant procedure be performed?

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

Should DURYSTA be readministered?

DURYSTA should not be readministered to an eye that received a prior DURYSTA.2

Patient Counseling FAQs

What are some key points to cover when counseling patients?

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

Access and Support FAQs

Is there reimbursement support for DURYSTA and my practice?

Yes, through Allergan EyeCue®—a convenient and efficient way to address your DURYSTA reimbursement questions. Learn more

Are training and support materials available?

Yes, we offer a variety of resources around administration training. Learn more

INDICATIONS AND USAGE & IMPORTANT SAFETY INFORMATION

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.

INDICATIONS AND USAGE & IMPORTANT SAFETY INFORMATION
COLLAPSE

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. 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.