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warnings and cautions
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) ] . 5.3 Patients without Baseline Corneal Endothelial Cell Density Prior to Initial Administration It is not recommended to readminister iDose TR if baseline central corneal endothelial cell density was not established prior to initial administration of iDose TR [see Warnings and Precautions (5.4 , 5.5) ] . 5.4 Recommended Minimum Corneal Endothelial Cell Density for Readministration Central corneal endothelial cell density should not be less than the recommended minimum listed in Table 2 prior to the initial administration of iDose TR and prior to each readministration. If corneal endothelial cell density was not established prior to the initial administration of iDose TR and only a single eye was implanted, corneal endothelial cell density in the un-implanted contralateral eye meeting the recommended minimum density may be used for eligibility determination for readministration of iDose TR (see Table 2 ). Table 2: Recommended Minimum Central Corneal Endothelial Cell Density Central Corneal Endothelial Cell Density Age Phakic Eyes Pseudophakic Eyes ≤ 45 years 2,200 (cells/mm 2 ) 1,540 (cells/mm 2 ) 46 to 55 years 2,000 (cells/mm 2 ) 1,400 (cells/mm 2 ) 56 to 65 years 1,800 (cells/mm 2 ) 1,260 (cells/mm 2 ) > 65 years 1,600 (cells/mm 2 ) 1,120 (cells/mm 2 ) 5.5 Corneal Endothelial Cell Loss iDose TR should be readministered with caution in eyes with 10% or greater loss in central corneal endothelial cell density from pre-administration baseline (adjusted for age-related 1% loss per year and for a 10% loss following an anterior segment surgical procedure [e.g., cataract surgery]). If baseline corneal endothelial cell density was not established prior to the initial administration of iDose TR and only a single eye is implanted, a 10% threshold level of endothelial cell density loss as a difference of the implanted eye versus un-implanted contralateral eye should be considered before readministering iDose TR. 5.6 Macular Edema Macular edema, including cystoid macular edema, has been reported during treatment with ophthalmic travoprost, including iDose TR intracameral implant. iDose TR should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema. 5.7 Intraocular Inflammation Prostaglandin analogs, including iDose TR, have been reported to cause intraocular inflammation. iDose TR should be used with caution in patients with active intraocular inflammation (e.g., uveitis) because the inflammation may be exacerbated. 5.8 Pigmentation Topical ophthalmic travoprost has been reported to cause increased pigmentation to pigmented tissues. Pigmentation is expected to increase as long as travoprost is administered. The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. After discontinuation of travoprost, pigmentation of the iris is likely to be permanent. The long-term effects of increased pigmentation are not known. Iris color change may not be noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of the iris become more brownish. Neither nevi nor freckles of the iris appear to be affected by treatment. While treatment with travoprost can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly. 5.9 Endophthalmitis Intraocular surgical procedures and injections have been associated with endophthalmitis. Proper aseptic technique must always be used with administering iDose TR, and patients should be monitored following the administration. 5.10 Magnetic Resonance Imaging (MRI) Conditional iDose TR is MR Conditional. Patients should be informed that the implant is MR Conditional (as noted on their Patient ID card). If the patient requires magnetic resonance imaging (MRI), they should inform their healthcare provider that they have an iDose TR implanted in their eye. A patient with the iDose TR may be safely scanned under the following conditions. Failure to follow these conditions may result in injury to the patient. Parameter Condition of Use / Information Nominal Values of Static Magnetic Field (T) 3.0 T or less Maximum Spatial Field Gradient (T/m and gauss/cm) 40-T/m (4,000-gauss/cm) Type of RF Excitation Circularly Polarized (CP) (i.e., Quadrature-Transmission) Transmit RF Coil Information Any transmit RF coil may be used Operating Mode of MR System Normal Operating Mode Maximum Whole Body Averaged SAR 2-W/kg (Normal Operating Mode) Maximum Head SAR 3.2-W/kg (Normal Operating Mode) Limits on Scan Duration Whole body averaged SAR of 2-W/kg for 60 minutes of continuous RF exposure (i.e., per pulse sequence or back-to-back sequences/series without breaks) MR Image Artifact The presence of this implant produces an imaging artifact. Therefore, carefully select pulse sequence parameters if the implant is located in the area of interest.
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.