Prostaglandin Analog

Idose TR

Approved 13 Dec 2023IntracameralImplant

Indications

iDose ® TR (travoprost intracameral implant) is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). iDose ® TR 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 dystrophy ( 4.2 ) Prior corneal transplantation ( 4.3 ) Hypersensitivity ( 4.4 )

4.1Ocular or Periocular

Infections iDose TR (travoprost intracameral implant) is contraindicated in patients with active or suspected ocular or periocular infections .

4.2Corneal Endothelial

Dystrophy iDose TR is contraindicated in patients with corneal endothelial cell dystrophy (e.g., Fuch's Dystrophy, corneal guttatae).

4.3Prior Corneal

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

4.4 Hypersensitivity iDose TR is contraindicated in patients with hypersensitivity to travoprost or to any other components of the product .

Warnings and precautions

Iridocorneal Angles : iDose TR should be used with caution in patients with narrow angles or other angle abnormalities ( 5.1 ) Device Dislocation : Monitor patients routinely to confirm the location of the iDose TR at the site of administration ( 5.2 ) Pigmentation : Increased pigmentation of the iris can occur. Iris pigmentation is likely to be permanent ( 5.8 )

5.1Iridocorneal

Angles iDose TR should be used with caution in patients with narrow iridocorneal angles (Shaffer grade < 3) or other angle abnormalities (e.g., peripheral anterior synechia, rubeosis iridis) that could impair proper placement of iDose TR at the planned implantation site.

At a glance

Brand name: Idose TR
Active substance: travoprost
Pharmacologic class: Prostaglandin Analog
Route: Intracameral
Dosage form: Implant
Applicant: Glaukos
Status: Prescription
FDA approval: 13 Dec 2023
Application: NDA218010-001

Indications

Contraindications

Ocular or periocular infections ( 4.1 ) Corneal endothelial dystrophy ( 4.2 ) Prior corneal transplantation ( 4.3 ) Hypersensitivity ( 4.4 )

4.1Ocular or Periocular

Infections iDose TR (travoprost intracameral implant) is contraindicated in patients with active or suspected ocular or periocular infections .

4.2Corneal Endothelial

Dystrophy iDose TR is contraindicated in patients with corneal endothelial cell dystrophy (e.g., Fuch's Dystrophy, corneal guttatae).

4.3Prior Corneal

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

4.4 Hypersensitivity iDose TR is contraindicated in patients with hypersensitivity to travoprost or to any other components of the product .

Warnings and precautions

5.1Iridocorneal

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

There are no adequate and well-controlled studies of iDose TR (travoprost intracameral implant) administration in pregnant women to inform a drug-associated risk. Subcutaneous administration of travoprost to pregnant mice and rats throughout the period of organogenesis produced embryo-fetal lethality, spontaneous abortion, and premature delivery at potentially clinically relevant doses. Advise pregnant women of a potential risk to a fetus. iDose TR should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Data Animal Data An embryo-fetal development study was conducted in pregnant rats administered travoprost once daily at doses up to 10 mcg/kg by subcutaneous injection from gestation day (GD) 6 to 17, to target the period of organogenesis. At 10 mcg/kg, 116 times the maximum human ocular dose (MHOD) of 1 implant per eye, based on body surface area (BSA), assuming sustained travoprost release from the implant for 6 months or 0.0139 mcg/kg/day, travoprost was teratogenic in rats, evidenced by an increase in the incidence of skeletal malformations as well as external and visceral malformations, including fused sternebrae, domed head and hydrocephaly.

Travoprost caused post-implantation loss at 10 mcg/kg. The fetal no observed adverse effect level (NOAEL) was 3 mcg/kg (34.5 times the maximum human ocular dose (MHOD) of 1 implant per eye, based on BSA). An embryo-fetal development study was conducted in pregnant mice administered travoprost once daily by subcutaneous injection at doses up to 1 mcg/kg from GD 6 to 16, to target the period of organogenesis. Travoprost induced an increase in post-implantation losses and a decrease in fetal viability in mice at subcutaneous doses > 0.3 mcg/kg.

The fetal NOAEL was 0.3 mcg/kg (1.7 times the MHOD based on BSA). The maternal NOAEL was 1 mcg/kg (5.8 times the MHOD based on BSA). Pre/postnatal development studies were conducted in rats administered travoprost once daily by subcutaneous injection from GD 7 (early embryonic period) to postnatal Day 21 (end of lactation period). At doses of greater than or equal to 0.12 mcg/kg/day (1.4 times the MHOD based on BSA), the incidence of post-natal mortality was increased, and neonatal body weight was decreased.

Neonatal development was also affected, evidenced by delayed eye opening, pinna detachment and preputial separation, and by decreased motor activity.

Idose TR

Indications

Contraindications

4.1Ocular or Periocular

4.2Corneal Endothelial

4.3Prior Corneal

Warnings and precautions

5.1Iridocorneal

At a glance

Two medicines in one question?

Idose TR

Indications

Contraindications

4.1Ocular or Periocular

4.2Corneal Endothelial

4.3Prior Corneal

Warnings and precautions

5.1Iridocorneal

At a glance

Two medicines in one question?

5.3Patients without Baseline Corneal Endothelial Cell Density Prior to Initial Administration

5.4Recommended Minimum Corneal Endothelial Cell Density for Readministration

5.5Corneal Endothelial Cell

5.6Macular Edema

5.7Intraocular Inflammation

5.8Pigmentation

5.9Endophthalmitis

5.10Magnetic Resonance Imaging (MRI)

3.0T

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Trials Experience

Composition

Official product information