IDOSE TR

iDose TR (travoprost intracameral implant) is a sterile intracameral implant containing 75 mcg of travoprost. The intracameral implant consists of a titanium implant reservoir with a membrane controlling the sustained release of travoprost. The sterile implant is pre-loaded in a sterile single-dose inserter to facilitate insertion directly through the trabecular meshwork of the anterior chamber angle into the sclera. Travoprost is a prostaglandin analog. Its chemical name is 5-heptenoic acid, 7-[(1R,2R,3R,5S)-3,5-dihydroxy-2-[(1E,3R)-3-hydroxy-4-[3-(trifluoromethyl)phenoxy]-1-buten-1-yl]cyclopentyl]-, 1-methylethyl ester, (5Z)-. Travoprost has a molecular formula of C 26 H 35 F 3 O 6 and a molecular weight of 500.55 g/mol. The chemical structure of travoprost is: Travoprost is a clear, colorless to slightly yellow oil that is very soluble in acetonitrile, methanol, octanol, and chloroform. It is practically insoluble in water. Figure-07

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 )

For ophthalmic intracameral administration ( 2.1 ) The intracameral administration should be carried out under standard aseptic conditions ( 2.2 ) 2.1 General Dosing Information iDose TR is a travoprost delivery system consisting of a travoprost releasing implant pre-loaded in a sterile, single-dose inserter. iDose TR is administered intracamerally through a small, clear corneal incision and is anchored into the sclera at the iridocorneal angle. iDose TR should not be readministered to an eye that received a prior iDose TR. 2.2 Administration 1. The procedure must be carried out under aseptic conditions which include use of sterile gloves and a sterile drape. 2. The eye should be anesthetized using general, retrobulbar, peribulbar, or topical anesthesia per standard operating room procedures. 3. The iDose TR implantation procedure must be performed under magnification that allows clear visualization of the anterior chamber angle and angle structures including trabecular meshwork, with the patient’s head in a stabilized position. The pupil should not be dilated prior to the procedure. 4. An intracameral miotic can be injected to deepen the angle prior to insertion of the iDose TR. 5. It is recommended that the implant surgery be performed from the temporal side, using a temporal clear corneal incision. The implant will be implanted through the angle and the trabecular meshwork into the sclera on the nasal side. 6. Remove the barrier pouch from the carton and examine for damage. Open the barrier pouch, discard the oxygen scavenger packet, and remove the blister tray with Tyvek® lid. Open the Tyvek lid containing the iDose TR pre-loaded inserter and present to the surgeon. The iDose TR implant and single-dose inserter should be handled in the sterile field. Caution: Do not use the iDose TR if the Tyvek lid has been opened or the packaging appears damaged. 7. Prepare for gonioscopy by turning the patient’s head away from the surgeon by approximately 15° to 25° and tilt the scope toward the surgeon by approximately 35°. The total combined angle should be approximately 50° to 60°. 8. Place a small amount of viscoelastic on the cornea. Position the gonioprism on the cornea using light touch gonioscopy. Adjust the microscope to locate and focus on the trabecular meshwork. 9. Inspect the angle with a gonioprism to ensure that a good view of all angle structures is available at the nasal implant location. 10. Hold the single-dose inserter as shown in Figure 1 with your index finger comfortably on the implant release button. Figure 1 11. Perform a detailed inspection of the tip of the sterile inserter under magnification to ensure that the iDose TR implant is present ( Figure 2 ) Figure 2 12. Create a clear corneal incision of approximately 2.4 mm at the temporal limbus location using an instrument of the surgeon’s choice. 13. Add a cohesive viscoelastic to the anterior chamber as needed to form the anterior chamber and improve visualization of the angle. Be careful not to overinflate. 14. Insertion of the implant: a. When ready for implantation, remove the safety clip which holds the release button in place by squeezing and rocking the clip backwards (see Figure 2 ). Place finger on the release button to ensure it remains in the forward position and does not prematurely release the implant. b. To smoothly enter the anterior chamber, slide the inserter tip with implant “side to side” in the incision. c. Advance to the pupillary margin and ensure there is sufficient cohesive viscoelastic on the cornea before replacing the gonioprism onto the cornea. d. Take care to avoid contact with the lens or cornea. e. Advance to the anterior chamber angle and approach the trabecular meshwork (see Figure 3 ). Figure 3 f. Press the implant directly through the trabecular meshwork, compressing the tissue until the implant anchor securely penetrates the sclera through the back wall of Schlemm’s canal. The base of the implant reservoir should be firmly in contact with and compressing the trabecular meshwork. g. Once the anchor of the implant is securely embedded in sclera, pause for the tissue to relax. Carefully slide the implant release button backwards to open the inserter tip with grasper and release the implant from the inserter ( Figure 4a ). Ensuring the implant has released from the inserter grasper, slowly remove the inserter straight back ( Figure 4b ). Avoid pulling the implant out of position. Figure 4a Figure 4b h. Apply slight pressure to the sides of the implant with the tip of the inserter to ensure the implant is fully anchored into scleral tissue. Note : If for any reason the implant appears loose or disengaged from the scleral tissue after the initial implantation, slide the implant release button back to fully open the graspers. Position the graspers between the ribs on the implant and regrasp the body of the implant between the ribs by pushing the release button forward and re-implant a minimum of ½ clock hour to either side. Do not re-implant at the same location. i. Withdraw the inserter from the eye. 15. Location of iDose TR in Trabecular Meshwork a. Perform a high-magnification examination to confirm that the implant is in proper position (i.e., the proximal end rests in the anterior chamber with an unobstructed membrane) (see Figure 5 ) and securely attached with the anchor thoroughly embedded in the sclera. Figure 5 b. It is normal for an edge of the implant to make contact with the iris. Note: In a normal iris (no viscoelastic in the anterior chamber and non-constricted pupil), the iris may obstruct the view of a portion of the cap of the implant. c. Irrigate and aspirate the anterior chamber with balanced salt solution to remove all viscoelastic. Press down on the posterior edge of the incision as needed to facilitate complete removal of viscoelastic. d. Inflate the anterior chamber with saline solution as needed to achieve physiologic pressure. Figure-01 Figure-02 Figure-03 Figure-04 Figure-05 Figure-06

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 endothelial cell dystrophy (e.g., Fuch’s Dystrophy, corneal guttatae). 4.3 Prior 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.

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 ( 5.3 )] 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 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.