IDOSE TR

Travoprost, an isopropyl ester prodrug, is hydrolyzed by esterases in the cornea and other intraocular tissues to its biologically active free acid. Systemically, travoprost free acid is metabolized to inactive metabolites via beta-oxidation of the α (carboxylic acid) chain to give the 1,2-dinor and 1,2,3,4-tetranor analogs, via oxidation of the 15-hydroxyl moiety, as well as via reduction of the 13, 14 double bond. Data from a pharmacokinetic study of 105 subjects evaluating two models of the t...

iDose TR was evaluated in two multicenter, 12-month, randomized, parallel-group, double-masked, controlled clinical trials in patients with OAG or OHT. In both trials (GC-010, NCT03519386, and GC-012, NCT03868124), iDose TR was compared to twice-daily topical administration of timolol maleate ophthalmic solution, 0.5%. In the first 3 months following administration, iDose TR demonstrated an IOP change from baseline of -6.6 to -8.4 mmHg in the study eye of patients with a mean baseline IOP of 24 mmHg (see Figure 6 ). Figure 6: Change from Baseline in Study Eye IOP (mmHg) and Treatment Differenc...

The following adverse reactions are described elsewhere in the labeling: Ocular or periocular infections [see Contraindications ( 4.1 )] Corneal endothelial dystrophy [see Contraindications ( 4.2 )] Prior corneal transplantation [see Contraindications ( 4.3 )] Hypersensitivity [see Contraindications ( 4.4 )] Device dislocation [see Warnings and Precautions ( 5.2 )] Macular edema [see Warnings and Precautions ( 5.6 )] Intraocular inflammation [see Warnings and Precautions ( 5.7 )] Pigmentation [s...

Ocular or periocular infections ( 4.1 ) Corneal endothelial dystrophy ( 4.2 ) Prior corneal transplantation ( 4.3 ) Hypersensitivity ( 4.4 ) 4.1 Ocular or Periocular Infections iDose TR (travoprost intracameral implant) is contraindicated in patients with active or suspected ocular or periocular infections . 4.2 Corneal Endothelial Dystrophy iDose TR is contraindicated in patients with corneal end...

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 ) 5.1 Iridocorneal Angles iDose TR should be used with caution in patients with narrow iridocorneal angles (Shaffer grade < 3) or other ...