bimatoprost ophthalmic implant (Rx)

Brand and Other Names:Durysta
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

intracameral biodegradable implant

  • 10mcg

Open-Angle Glaucoma or Ocular Hypertension

Indicated to reduce intraocular pressure in patients with open-angle glaucoma or ocular hypertension

10-mcg implant by intracameral administration

Do not readminister to an eye that received a prior bimatoprost ophthalmic implant

Safety and efficacy not established

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Adverse Effects

>10%

Conjunctival hyperemia (27%)

1-10%

Headache (5%)

5-10%

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

1-5%

  • Lacrimation increased
  • Corneal edema
  • Aqueous humor leakage
  • Iris adhesions
  • Ocular discomfort
  • Corneal touch
  • Iris hyperpigmentation
  • Anterior chamber flare
  • Anterior chamber inflammation
  • Macular edema

<1%

Hyphema

Iridocyclitis

Uveitis

Corneal opacity

Product administered at inappropriate site

Corneal decompensation

Cystoid macular edema

Drug hypersensitivity

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Warnings

Contraindications

Hypersensitivity

Active or suspected ocular or periocular infections

Corneal endothelial cell dystrophy (eg, Fuchs endothelial dystrophy)

Patients with prior corneal transplantation or endothelial cell transplants (eg, Descemet stripping automated endothelial keratoplasty [DSAEK])

Absence or rupture of posterior lens capsule owing to the risk of implant migration into the posterior segment; laser posterior capsulotomy in pseudophakia is not contraindicated if the intraocular lens fully covers the posterior capsule opening

Cautions

May cause corneal adverse reactions and increased risk of corneal endothelial cell loss; caution when prescribing in patients with limited corneal endothelial cell reserve

Caution in patients with narrow iridocorneal angles (Shaffer grade <3) or anatomical obstruction (eg, scarring) that may prohibit the implant from properly settling in the inferior angle

Macular edema, including cystoid macular edema, reported; caution in patients with aphakic and pseudophakic glaucoma who have a torn posterior lens capsule or in patients with known risk factors for macular edema

May cause intraocular inflammation; caution in patients with active intraocular inflammation (eg, uveitis) as the condition may be exacerbated

May cause changes to pigmented tissues (eg, increased iris pigmentation), which are likely to be permanent; therapy may continue following increased iris pigmentation; examine these patients regularly

Intraocular surgical procedures and injections have been associated with endophthalmitis; proper aseptic technique must always be used; monitor patients following administration

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Pregnancy & Lactation

Pregnancy

There are no adequate and well-controlled studies regarding use in pregnant women to inform a drug-associated risk

Animal studies

  • Oral administration to pregnant rats and mice throughout organogenesis did not produce adverse maternal or fetal effects at clinically relevant exposures

Lactation

Data are not available regarding the presence in human milk, effects on breastfed infants, or effects on milk production

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Prostaglandin analog; lowers intraocular pressure by increasing aqueous humor outflow through the trabecular meshwork and uveoscleral routes

Pharmacokinetics

Concentrations were below the lower limit of quantitation (0.001 ng/mL)

Maximum bimatoprost concentration observed in any patient was 0.00224 ng/mL

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Administration

Intracameral Preparation

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

Do not dilate the eye before procedure

See Prescribing Information for complete instructions

Intracameral Administration

Limit administration to a single implant per eye without retreatment

See Prescribing Information for complete instructions

Storage

Refrigerate at 2-8ºC (36-46ºF)

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Images

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.