Susvimo (Page 2 of 7)

2.5 Ocular Implant Insertion

SUSVIMO ocular implant insertion is a surgical procedure that is performed in an operating room. The procedure must be performed under aseptic conditions by a physician experienced in vitreoretinal surgery [see Dosage and Administration (2.1)].

The ocular implant is filled with SUSVIMO (ranibizumab injection) immediately prior to insertion. No more than 30 minutes should pass between the initial fill of the ocular implant and the insertion into the patient’s eye.

After placing an infusion line in the eye, create at least a 6×6 mm peritomy of the conjunctiva and Tenon’s capsule centered around the selected SUSVIMO implant location in the supero-temporal quadrant. Perform careful conjunctival incision, hemostasis of the underlying sclera, and generous undermining of Tenon’s capsule. Using aseptic technique, fill the ocular implant [see Dosage and Administration (2.4)]. Using an MVR blade, create a full thickness dissection of the sclera 4 mm from the limbus until the pars plana is fully visible, with final target scleral incision length of 3.5 mm. Using a 532 nm laser endoprobe, apply contiguous, overlapping laser spots starting at 300 mW 1000 ms along the full length of the exposed pars plana and repeat until complete ablation is achieved. Pass a 3.2 mm slit knife perpendicularly through the center of the scleral dissection to open the underlying pars plana. Use the insertion tool to slowly insert the SUSVIMO implant into the sclero-pars plana incision perpendicular to the globe, ensuring that the long axis of the implant flange is properly aligned with the sclero-pars plana incision. Using the closed gripper tips of the insertion tool, seat the implant flush against the sclera. Clean any residual vitreous around the implant flange using a vitrector. Suture both Tenon’s capsule and conjunctiva, using scleral anchoring at the apex of the peritomy, ensuring complete coverage of the implant flange. Refer to the complete SUSVIMO Instructions for Use for the initial fill and implant procedure included in the insertion tool assembly carton for further details.

2.6 Ocular Implant Removal

Removal of the SUSVIMO ocular implant is a surgical procedure that is performed in an operating room. The procedure must be performed under aseptic conditions by a physician experienced in vitreoretinal surgery [see Dosage and Administration (2.1)].

After placing an infusion line in the eye, create at least a 6×6 mm peritomy of the conjunctiva and Tenon’s capsule around the SUSVIMO ocular implant flange. Remove any fibrous capsule or scar tissue that may have formed over the implant flange and septum using scalpel and forceps. With the explant tool oriented perpendicular to the globe, align the contoured tips with the long axis of the implant flange and grasp underneath the implant flange. Once the implant is secured in the explant tool, pull the implant from the eye in a perpendicular motion. Clear any vitreous prolapse present within or around the scleral wound using a vitrector. Completely close the scleral incision with multiple non-absorbable sutures. Close the Tenon’s capsule and conjunctiva to completely cover the scleral incision. Refer to the complete Instructions for Use for the implant removal procedure included in the explant tool carton for further details.

2.7 Ocular Implant Refill-Exchange Procedure

The SUSVIMO ocular implant refill-exchange procedure must be performed under strict aseptic conditions by a physician experienced in ophthalmic surgery [see Dosage and Administration (2.1)]. This includes the use of a surgical mask, sterile gloves, and a lid speculum.

​Prior to and after the refill-exchange procedure, perform a dilated slit lamp exam and/or dilated indirect ophthalmoscopy to inspect the implant in the vitreous cavity through the pupil to identify if dislodgement of the implant septum has occurred [see Figure 31 and Warnings and Precautions (5.4)]. If the septum has dislodged, any further refill-exchange procedures should not be performed because normal device functioning cannot be assured. Discontinue treatment with SUSVIMO (ranibizumab injection) following septum dislodgement and consider implant removal should the benefit of the removal procedure outweigh the risk.

Step 1: Gather the supplies needed. One SUSVIMO Refill Needle (34-gauge with a 5 µm integrated filter) with clear cap (included) One SUSVIMO (ranibizumab injection) 100 mg/mL vial (included) One sterile 1 mL Luer Lock syringe (not included) One sterile 5-micron filter needle (19-gauge × 1½ inch) (not included) Additional materials required to perform the procedure but are not provided are: Anesthetic ophthalmic solutions Ophthalmic broad-spectrum microbicide solution Cotton tips and gauze Sterile powder free gloves Face masks Lid speculum Magnification such as visor or loupes Task lighting Indirect ophthalmoscope and lens Sterile drape (optional for refill-exchange procedure)
Step 2: Inspect Packaging and Components Prior to use in the clinic, inspect the packaging of the components for damage. Do not use if the sterility has been compromised or the contents have been dropped, damaged, or tampered with. Check the expiration date printed on the label. Remove the vial from the carton. Note: the outside of the vial is not sterile. Use aseptic technique to open packaging and remove the sterile refill needle from the tray. Inspect components and place onto sterile field (see Figure 16).		(click image for full-size original) Figure 16
Step 3: Inspect SUSVIMO (ranibizumab injection) Visually inspect the contents of the SUSVIMO (ranibizumab injection) vial for particulate matter and discoloration. SUSVIMO should be colorless to pale brown Do not use if particulate, cloudiness, or discoloration are visible.
Step 4: Patient Preparation ​Dilate the pupil of the eye. ​Perform slit lamp examination and/or indirect ophthalmoscopy to inspect the implant and its components in the vitreous cavity through the dilated pupil. Position the patient on exam chair in the supine position at approximately 20° to 30° angle for optimal visualization of the implant. Apply a broad-spectrum microbicide to the periocular skin, eyelid, and ocular surface prior to the refill-exchange procedure. The use of a sterile drape is up to the physician’s discretion. Perform the procedure under topical anesthesia. If needed, subconjunctival anesthesia may be administered in the nasal quadrant, away from the implant.
Step 5: Transfer Dose from Vial to Syringe		(click image for full-size original) Figure 17
Note:	Use the filter needle to withdraw SUSVIMO (ranibizumab injection) from the vial.
Do not use the SUSVIMO refill needle for this step. Prepare ranibizumab vial by removing the flip-off cap and disinfecting the rubber vial septum with alcohol. Attach a filter needle to the syringe by screwing it tightly onto the Luer lock (see Figure 17). Carefully remove the needle cap by pulling it straight off. Using aseptic technique, withdraw all of the contents of the SUSVIMO (ranibizumab injection) vial through the filter needle into the syringe.
​Step 6: Remove Air from Syringe ​With the filter needle attached, hold the syringe with the needle pointing up. ​If there are any air bubbles, gently tap the syringe with your finger until the bubbles rise to the top (Figure 18). ​Slowly push the plunger rod just until the air is expelled from the syringe and needle. – It is important to preserve as much drug as possible in order to completely refill the implant ​Remove and properly dispose of the filter needle after air is removed from the syringe.		Figure 18
Step 7: Attach SUSVIMO Refill Needle Do not use the filter needle to fill the implant. Attach the SUSVIMO refill needle firmly onto the syringe by screwing it tightly onto the Luer lock (see Figure 19). Ensure that the refill needle is attached to the syringe. Carefully remove the needle cap, pulling straight off to avoid damage to the needle cannula. Do not wipe the needle at any time.		(click image for full-size original) Figure 19
Step 8: Remove Any Remaining Air from Syringe and Adjust Drug Dose ​With the refill needle attached, hold the syringe with the needle pointing up. If there are any air bubbles, gently tap the syringe with your finger until the bubbles rise to the top (see Figure 20). Slowly push the plunger rod until all air is expelled from the syringe and needle and the uppermost edge of the black plunger tip is aligned with the 0.1 mL dose mark (see Figure 21).		(click image for full-size original) Figure 20 (click image for full-size original) Figure 21
Step 9: Inspect the Syringe for Air Bubbles		(click image for full-size original) Figure 22
Note:	Ensure no air bubbles are present in the syringe and needle hub. Air injected into the implant could result in slower drug release.
Inspect the syringe and the needle hub using magnification to ensure that no air bubbles are present (see Figure 22).
Note:	Use the syringe within 15 minutes of removing all air and adjusting the drug dose to avoid drug solution drying in the needle and impeding fluid flow.Do not use the refill needle or syringe if the needle is clogged.
Step 10: Stabilize the globe and orient the refill needle		(click image for full-size original) Figure 23 (click image for full-size original) Figure 24
Note:	Perform the refill-exchange procedure using magnification (e.g., loupes, reading glasses, magnifiers) for visual assistance.
After placing the lid speculum in the eye, stabilize the globe with a cotton-tipped applicator to minimize eye movement (see Figure 23). – Recommend standing on the contralateral side of the implanted eye, with the patient looking down and toward their nose to optimally expose the implant. Orient the refill needle perpendicular to the globe (see Figure 24).
Step 11: Insert the Refill Needle		(click image for full-size original) Figure 25 (click image for full-size original) Figure 26
Note:	Insert needle at the very center of the implant septum and perpendicular to the implant to ensure the needle inserts fully. Do not maneuver if there is resistance as it will bend the needle.Do not use a bent refill needle; replace if bent or if damage is suspected.
Targeting the center of the implant septum, insert the refill needle perpendicularly through the conjunctiva and into the implant septum (see Figure 25). – If excessive resistance, withdraw the refill needle. Orient and insert again. – Do not twist when encountering conjunctiva and Tenon’s capsule to gain access to the septum, as damage to the overlying tissue and to the septum of the device may result. Continue inserting the needle until the soft stop of the refill needle makes physical contact with the conjunctiva (see Figure 26) to provide a tactile cue that optimal contact has been made.
Step 12: Refill the SUSVIMO Implant Refill the implant slowly, by delivering the entire contents of the syringe into the implant, over approximately 5 to 10 seconds, to avoid pressure build-up in the implant reservoir. The soft stop of the refill needle must remain in contact with the conjunctiva throughout the procedure. As ranibizumab is administered into the implant, existing solution from the implant should immediately begin to fill the refill needle fluid collection chamber (see Figure 27). If fluid is not observed collecting in the refill needle fluid collection reservoir, stop injecting and ensure the refill needle is inserted into the center of the implant septum at a perpendicular angle and the soft stop is in contact with the conjunctiva. Administer all of the syringe contents in order to achieve the target replacement ranibizumab concentration in the implant reservoir.		(click image for full-size original) Figure 27
Step 13: Withdraw the Syringe Withdraw the syringe perpendicular to the globe to avoid damaging the septum (see Figure 28). A cotton-tipped applicator may be used to provide counter traction to the conjunctiva during needle withdrawal.		(click image for full-size original) Figure 28
Step 14: Dispose of the Used Components Do not recap the needle or detach it from the syringe. Dispose of the used syringe together with the refill needle in a sharps disposal container or in accordance with local requirements.
Step 15: Perform Indirect Ophthalmoscopy ​Perform dilated indirect ophthalmoscopy (and slit lamp exam as needed) to ensure continued proper position of the implant and its components (e.g., septum) in the vitreous cavity and to examine for complications.