Dosing & Uses
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
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
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
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.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
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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Formulary
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