Prostaglandin Analog

Durysta

Approved 4 Mar 2020EyeImplant

Indications

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 a prostaglandin analog indicated for the reduction of intraocular pressure (IOP) in patients with open angle glaucoma (OAG) or ocular hypertension (OHT). ( 1 )

Contraindications

Ocular or periocular infections ( 4.1 ) Corneal endothelial cell dystrophy ( 4.2 ) Prior corneal transplantation ( 4.3 ) Absent or ruptured posterior lens capsule ( 4.4 ) Hypersensitivity ( 4.5 )

4.1Ocular or Periocular Infections

DURYSTA is contraindicated in patients with active or suspected ocular or periocular infections.

4.2Corneal Endothelial Cell Dystrophy

DURYSTA is contraindicated in patients with corneal endothelial cell dystrophy (e.g., Fuchs’ Dystrophy) [ see Warnings and Precautions ( 5.1 ) ] .

4.3Prior Corneal Transplantation

DURYSTA is contraindicated in patients with prior corneal transplantation, or endothelial cell transplants [e.g., Descemet’s Stripping Automated Endothelial Keratoplasty (DSAEK)].

4.4Absent or Ruptured Posterior Lens Capsule

DURYSTA is contraindicated in patients whose posterior lens capsule is absent or ruptured, due to the risk of implant migration into the posterior segment. Laser posterior capsulotomy in pseudophakic patients is not a contraindication for DURYSTA use if the intraocular lens fully covers the opening in the posterior capsule.

4.5Hypersensitivity

DURYSTA is contraindicated in patients with hypersensitivity to bimatoprost or to any other components of the product [ see Adverse Reactions ( 6.1 ) ] .

Warnings and precautions

Endothelial cell loss : Due to possible corneal endothelial cell loss, administration of DURYSTA should be limited to a single implant per eye without retreatment. ( 5.1 ) Corneal Adverse Reactions : DURYSTA has been associated with corneal adverse reactions and risks are increased with multiple implants. Use caution in patients with limited corneal endothelial cell reserve. ( 5.1 ) Iridocorneal Angle : DURYSTA should be used with caution in patients with narrow angles or anatomical angle obstruction.

At a glance

Brand name: Durysta
Active substance: bimatoprost
Pharmacologic class: Prostaglandin Analog
Route: Eye
Dosage form: Implant
Applicant: Abbvie
Status: Prescription
FDA approval: 4 Mar 2020
Application: NDA211911-001

Indications

Contraindications

Ocular or periocular infections ( 4.1 ) Corneal endothelial cell dystrophy ( 4.2 ) Prior corneal transplantation ( 4.3 ) Absent or ruptured posterior lens capsule ( 4.4 ) Hypersensitivity ( 4.5 )

4.1Ocular or Periocular Infections

DURYSTA is contraindicated in patients with active or suspected ocular or periocular infections.

4.2Corneal Endothelial Cell Dystrophy

DURYSTA is contraindicated in patients with corneal endothelial cell dystrophy (e.g., Fuchs’ Dystrophy) [ see Warnings and Precautions ( 5.1 ) ] .

4.3Prior Corneal Transplantation

DURYSTA is contraindicated in patients with prior corneal transplantation, or endothelial cell transplants [e.g., Descemet’s Stripping Automated Endothelial Keratoplasty (DSAEK)].

4.4Absent or Ruptured Posterior Lens Capsule

4.5Hypersensitivity

DURYSTA is contraindicated in patients with hypersensitivity to bimatoprost or to any other components of the product [ see Adverse Reactions ( 6.1 ) ] .

Warnings and precautions

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

There are no adequate and well-controlled studies of DURYSTA (bimatoprost intracameral implant) administration in pregnant women to inform a drug associated risk. Oral administration of bimatoprost to pregnant rats and mice throughout organogenesis did not produce adverse maternal or fetal effects at clinically relevant exposures. Oral administration of bimatoprost to rats from the start of organogenesis to the end of lactation did not produce adverse maternal, fetal or neonatal effects at clinically relevant exposures [see Animal Data] .

Data Animal Data In an embryofetal development rat study, oral administration of bimatoprost to pregnant rats during organogenesis produced abortion at 0.6 mg/kg/day (1770-times the human systemic exposure to bimatoprost from DURYSTA, based on C max and a blood-to plasma partition ratio of 0.858). The No Observed Adverse Effect Level (NOAEL) for abortion was 0.3 mg/kg/day (estimated at 470-times the human systemic exposure to bimatoprost from DURYSTA, based on C max ).

No fetal abnormalities were observed at doses up to 0.6 mg/kg/day. In an embryofetal development mouse study, oral administration of bimatoprost to pregnant mice during organogenesis produced abortion and early delivery at 0.3 mg/kg/day (2240-times the human systemic exposure to bimatoprost from DURYSTA, based on plasma C max level; blood-to plasma partition ratio of 0.858). The NOAEL for abortion and early delivery was 0.1 mg/kg/day (400-times the human systemic exposure to bimatoprost from DURYSTA, based on C max ).

No fetal abnormalities were observed at doses up to 0.6 mg/kg/day (5200-times the human systemic exposure to bimatoprost from DURYSTA, based on C max ). In a pre/postnatal development study, oral administration of bimatoprost to pregnant rats from gestation day 7 through lactation resulted in reduced gestation length, increased late resorptions, fetal deaths, and postnatal pup mortality, and reduced pup body weight at 0.3 mg/kg/day (estimated 470-times the human systemic exposure to bimatoprost from DURYSTA, based plasma C max and a blood-to plasma partition ratio of 0.858).

No adverse effects were observed in rat offspring at 0.1 mg/kg/day (estimated 350-times the human systemic exposure to bimatoprost from DURYSTA, based on plasma C max ).

Adverse reactions

The following clinically significant adverse reactions are described elsewhere in labeling: Implant migration [see Contraindications ( 4.4 )] Hypersensitivity [ see Contraindications ( 4.5 ) ] Corneal adverse reactions [ see Warnings and Precautions ( 5.1 ) ] Macular edema [ see Warnings and Precautions ( 5.3 ) ] Intraocular inflammation [ see Warnings and Precautions ( 5.4 ) ] Pigmentation [ see Warnings and Precautions ( 5.5 ) ] Endophthalmitis [ see Warnings and Precautions ( 5.6 ) ] 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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common ocular adverse reaction observed in two randomized, active-controlled clinical trials with DURYSTA in patients with OAG or OHT was conjunctival hyperemia, which was reported in 27% of patients.

Other common ocular 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, and iritis. Ocular adverse reactions occurring in 1-5% of patients were anterior chamber cell, lacrimation increased, corneal edema, aqueous humor leakage, iris adhesions, ocular discomfort, corneal touch, iris hyperpigmentation, anterior chamber flare, anterior chamber inflammation, and macular edema.

The following additional adverse drug reactions occurred in less than 1% of patients: hyphema, iridocyclitis, uveitis, corneal opacity, corneal thickening, product administered at inappropriate site, corneal decompensation, cystoid macular edema, and drug hypersensitivity. The most common nonocular adverse reaction was headache, which was observed in 5% of patients.

6.2Postmarketing Experience

The following adverse reactions have been identified during postapproval use of DURYSTA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Eye disorders : endophthalmitis

Durysta

Indications

Contraindications

4.1Ocular or Periocular Infections

4.2Corneal Endothelial Cell Dystrophy

4.3Prior Corneal Transplantation

4.4Absent or Ruptured Posterior Lens Capsule

4.5Hypersensitivity

Warnings and precautions

At a glance

Two medicines in one question?

Durysta

Indications

Contraindications

4.1Ocular or Periocular Infections

4.2Corneal Endothelial Cell Dystrophy

4.3Prior Corneal Transplantation

4.4Absent or Ruptured Posterior Lens Capsule

4.5Hypersensitivity

Warnings and precautions

At a glance

Two medicines in one question?

5.1Corneal Adverse Reactions

5.2Iridocorneal Angle

5.3Macular Edema

5.4Intraocular Inflammation

5.5Pigmentation

5.6Endophthalmitis

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Trials Experience

6.2Postmarketing Experience

Composition

Official product information