Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS 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 [see Warnings and Precautions ( 5.8 )] Endophthalmitis [see Warnings and Precautions ( 5.9 )] In controlled studies, the most common ocular adverse reactions reported in 2% to 6% of patients were increases in intraocular pressure, iritis, dry eye, and visual field defects ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Glaukos Corporation at 1-888-404-1644 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical 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 following adverse events rates are derived from three randomized, double-masked clinical trials in which 868 patients with open angle glaucoma (OAG) or ocular hypertension (OHT) received an iDose TR and were followed for one year.
The most commonly reported ocular adverse reactions (2% to 6%) were increases in intraocular pressure, iritis, dry eye, visual field defects, eye pain, ocular hyperaemia, and reduced visual acuity.
Ocular adverse reactions reported in less than 2% of patients were conjunctival hemorrhage, photophobia, punctate keratitis, blepharitis, eye irritation, corneal abrasion, device dislocation, vitreous detachment, and foreign body sensation in eyes.
5 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 ) 5.1 Iridocorneal 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.
5.2 Device Dislocation Dislocation of the iDose TR has been observed in clinical trials.
Patients should be monitored routinely to confirm the location of the iDose TR at the site of administration.
If the iDose TR implant becomes dislocated, it should be surgically removed [see Dosage and Administration (2.3 , 2.4) ] .
Like all medications, Idose Tr can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: